Video Abstract

Video Abstract

CONTEXT:

Digital distraction is being integrated into pediatric pain care, but its efficacy is currently unknown.

OBJECTIVE:

To determine the effect of digital technology distraction on pain and distress in children experiencing acutely painful conditions or procedures.

DATA SOURCES:

Medline, Embase, Cochrane Library, Cumulative Index to Nursing and Allied Health Literature, PsycINFO, Institute of Electrical and Electronics Engineers Xplore, Ei Compendex, Web of Science, and gray literature sources.

STUDY SELECTION:

Quantitative studies of digital technology distraction for acutely painful conditions or procedures in children.

DATA EXTRACTION:

Performed by 1 reviewer with verification. Outcomes were child pain and distress.

RESULTS:

There were 106 studies (n = 7820) that reported on digital technology distractors (eg, virtual reality and video games) used during common procedures (eg, venipuncture, dental, and burn treatments). No studies reported on painful conditions. For painful procedures, digital distraction resulted in a modest but clinically important reduction in self-reported pain (standardized mean difference [SMD] −0.48; 95% confidence interval [CI] −0.66 to −0.29; 46 randomized controlled trials [RCTs]; n = 3200), observer-reported pain (SMD −0.68; 95% CI −0.91 to −0.45; 17 RCTs; n = 1199), behavioral pain (SMD −0.57; 95% CI −0.94 to −0.19; 19 RCTs; n = 1173), self-reported distress (SMD −0.49; 95% CI −0.70 to −0.27; 19 RCTs; n = 1818), observer-reported distress (SMD −0.47; 95% CI −0.77 to −0.17; 10 RCTs; n = 826), and behavioral distress (SMD −0.35; 95% CI −0.59 to −0.12; 17 RCTs; n = 1264) compared with usual care.

LIMITATIONS:

Few studies directly compared different distractors or provided subgroup data to inform applicability.

CONCLUSIONS:

Digital distraction provides modest pain and distress reduction for children undergoing painful procedures; its superiority over nondigital distractors is not established. Context, preferences, and availability should inform the choice of distractor.

Close to 2.5 million children visit Canadian emergency departments (EDs) each year to be treated for potentially painful injuries and illnesses.1  When hospitalized, almost 80% of children will undergo several (average 6.3) procedures per day,2  and many will experience moderate to severe pain.3  Poorly managed pain adversely impacts a child’s well-being and can lead to a reduced ability to cope effectively with future pain.46 

The prevention and management of children’s pain remains suboptimal.2,7  Children do not always perceive pharmacologic treatments to be effective8  because they are not always practical for urgent procedures,9  can cause adverse effects, and may not reduce anticipatory distress.10  Nonpharmacologic approaches such as distraction for children undergoing painful procedures are increasingly being adopted.1113  It is unclear how the type of distraction may affect efficacy for varied acutely painful conditions and procedures.11 

Digital technology distractors may be of particular relevance given their pervasive use in society, but their uptake is currently limited. Almost all major Canadian pediatric EDs have access to some type of digital screen,14  but ED physicians do not report using these tools regularly to treat or prevent pain.15  Although there have been many trials focusing on digital technology distraction published in recent years, they have not yet been synthesized, thereby limiting our understanding of their true impact.

To address this knowledge gap, we systematically reviewed evidence for the following question: for children with an acutely painful condition or undergoing an acutely painful medical procedure, what is the effect of digital technology as a distraction on their experienced pain and distress as compared with (1) no distraction and (2) other forms of distraction (digital or nondigital)?

We followed a predetermined protocol (International Prospective Register of Systematic Reviews CRD42017077622). Given the large number of included studies, we report only on the primary outcomes of pain and distress.

A research librarian implemented a peer-reviewed16  search strategy in October 2017 in ePub Ahead of Print, In-Process and Other Nonindexed Citations, Ovid Daily Medline Daily, and Ovid Medline; Ovid Embase; Wiley Cochrane Library; Cumulative Index to Nursing and Allied Health Literature (CINAHL) Plus with full text via Elton B. Stephens Co. host (EBSCOhost); Ovid PsycINFO; Institute of Electrical and Electronic Engineers Xplore; Ei Compendex via Engineering Village; and Web of Science Core Collection via Clarivate Analytics (Supplemental Information). We searched for gray literature via health technology assessment agency Web sites (Canadian Agency for Drugs and Technologies in Health [CADTH] and Turning Research Into Practice [TRIP]), clinical trial registries (clinicaltrials.gov) and Web search engines (Google). In November 2018, we updated the search in Medline, Embase, CINAHL, Ei Compendex, Web of Science, the CADTH Web site, the TRIP database, and Google. We also scanned reference lists (included studies and relevant reviews) and contacted 6 external content experts and the authors of ongoing research. We used EndNote (version X5; Clarivate Analytics, Philadelphia, PA) to manage records and remove duplicates.

Table 1 shows the eligibility criteria for inclusion of studies in the review. We included all quantitative primary studies reporting on digital technologies used as a distraction for children with acutely painful medical conditions or having painful procedures in any clinical setting. Birnie et al17  defined distraction as “a shifting of attention away from pain … to stimuli that are more engaging or enjoyable.” We defined acute pain as any pain related to an injury, harm, or repair that was of short duration (ie, <30 days), typically occurring as part of a single treatable incident.18  We included any medical procedure that could cause pain.2  Comparators were (1) usual care (could have included spontaneous caregiver or health care provider interaction without study-provided guidance) or (2) another form of distraction (digital or nondigital; eg, blowing bubbles or nonmedical conversation); we also included studies with no comparison group. We allowed for the use of similar cointerventions (eg, topical anesthetics) among groups being compared. The primary outcomes were child pain and distress (including anxiety, stress, and fear).

TABLE 1

Study Eligibility Criteria

IncludeExclude
Population Children (≤21 y old) with acutely painful conditions and/or who are undergoing a painful medical procedure Adults (>21 y old), animal studies, chronic pain conditions without acute pain 
Studies of children and adults (mixed population) may be included if (1) data for children may be isolated, (2) ≥80% of the sample is ≤21 y old, or (3) the mean ±1.5 SD age is ≤21 y old  
Subgroups: age, sex, clinical condition, type of procedure, setting, severity of pain, active (requires engagement of the child; eg, playing a video game) or passive (requires the child’s attention but not engagement; eg, television watching) distraction  
Intervention Any digital technology used as a form of distraction, including but not limited to television, DVDs, videos, personal computers or laptops, tablets or iPads, smartphones, mobile apps, video games, virtual reality, and humanoid robots Digital technologies used for other reasons (eg, teaching and discharge instruction), nondigital technologies (eg, music, iPod, and radio); multicomponent interventions in which the effect of distraction could not be isolated 
Comparators (1) No distraction, (2) any other form of distraction (may be digital or nondigital), (3) no comparator (study design includes no comparison group) We will not exclude by comparator 
Outcomes Primary: child pain and distress (broadly defined to include anxiety, stress, or other relevant descriptions); any form of measurement is acceptable (eg, self-report, proxy report, and observed) — 
Timing Any — 
Setting Any — 
Study design Any quantitative primary research design except case reports and case series Qualitative research and nonresearch (eg, opinion pieces, commentaries, and letters) 
Language Any — 
Date Any — 
IncludeExclude
Population Children (≤21 y old) with acutely painful conditions and/or who are undergoing a painful medical procedure Adults (>21 y old), animal studies, chronic pain conditions without acute pain 
Studies of children and adults (mixed population) may be included if (1) data for children may be isolated, (2) ≥80% of the sample is ≤21 y old, or (3) the mean ±1.5 SD age is ≤21 y old  
Subgroups: age, sex, clinical condition, type of procedure, setting, severity of pain, active (requires engagement of the child; eg, playing a video game) or passive (requires the child’s attention but not engagement; eg, television watching) distraction  
Intervention Any digital technology used as a form of distraction, including but not limited to television, DVDs, videos, personal computers or laptops, tablets or iPads, smartphones, mobile apps, video games, virtual reality, and humanoid robots Digital technologies used for other reasons (eg, teaching and discharge instruction), nondigital technologies (eg, music, iPod, and radio); multicomponent interventions in which the effect of distraction could not be isolated 
Comparators (1) No distraction, (2) any other form of distraction (may be digital or nondigital), (3) no comparator (study design includes no comparison group) We will not exclude by comparator 
Outcomes Primary: child pain and distress (broadly defined to include anxiety, stress, or other relevant descriptions); any form of measurement is acceptable (eg, self-report, proxy report, and observed) — 
Timing Any — 
Setting Any — 
Study design Any quantitative primary research design except case reports and case series Qualitative research and nonresearch (eg, opinion pieces, commentaries, and letters) 
Language Any — 
Date Any — 

DVD, digital versatile disk; —, not applicable.

Using a piloted form, 2 reviewers independently screened all records by title and abstract then by full text in Microsoft Office Excel (version 2016; Microsoft Corporation, Redmond, WA). The final inclusion of studies was determined by consensus. We sought the opinion of a third reviewer with methodologic or content expertise when needed.

Using a piloted form in Microsoft Excel 2016, 1 reviewer independently extracted study characteristics, population characteristics, setting, intervention and comparator(s), and outcome data. This reviewer also categorized the studies on the basis of predetermined subgroups of interest (Supplemental Table 8). When needed, we estimated data points from graphs using Plot Digitizer software (http://plotdigitizer.sourceforge.net/). A second reviewer verified the extraction and subgroup categorizations, and a statistician independently verified all data entered into meta-analyses. Reviewers resolved disagreements by discussion. We contacted study authors twice via e-mail when data were missing or unclear.

We assessed the risk of bias of the included studies in duplicate using the following tools: Cochrane’s risk-of-bias tool19  for randomized controlled trials (RCTs) and nonrandomized controlled trials, an adapted tool developed by the Cochrane Effective Practice and Organization of Care Group20  for before-after and time series studies, and a Modified Newcastle-Ottawa Quality Assessment Scale21  for cross-sectional studies. The final rating was determined by consensus.

We synthesized data from randomized trials separately from the data obtained from other study designs. We first pooled data from RCTs and quasi RCTs via pairwise meta-analysis using the DerSimonian and Laird method random-effects model22,23  in Review Manager (version 5.3; Nordic Cochrane Centre, Cochrane Collaboration, Copenhagen, Denmark). The randomized trials were the main focus of our analyses because these offer higher internal validity than the other study designs included.

Self-report is the preferred measure of assessment for children who are able to describe their own pain, but it is not free from limitations.24  For this reason, studies often provide self-report alongside other measures (eg, observer reports and behavioral assessments; ie, by using a tool designed to assess pain- or distress-related behaviors). We therefore performed separate pain and distress meta-analyses for each type of assessment (ie, self-reported, observed, or behavioral) using mean differences (MDs) or standardized mean differences (SMDs) (results of studies that measure outcomes using different tools are standardized to a uniform scale) and 95% confidence intervals (CIs). We described non-RCTs and studies with inadequate data for meta-analysis in tables and compared findings to those of the RCTs.

We preferentially used data recorded during the first (if there were multiple) painful procedure or the closest time point thereafter. We preferentially used first-period data from crossover trials. When data were provided for multiple time points or observers, we produced a composite score.25  We computed SDs assuming a correlation of 0.5 between measurements unless data were available to compute correlations manually. To facilitate the interpretation of the clinical significance of the findings, we reexpressed SMDs using the mean control group SD for tools commonly used by studies within the meta-analyses and presented the absolute and relative differences in results tables.

We used the I2 statistic,26  the degree of overlap in CIs, and the direction of effect estimates across studies to quantify heterogeneity. We explored heterogeneity using the following between-study subgroup analyses: age category, type of patient population (added post hoc on the recommendation of a peer reviewer), setting, condition or procedure, type of digital technology distraction, active (requiring child engagement) versus passive (engagement not required) distraction,27  presence of cointerventions, and measurement scale. We conducted sensitivity analyses on the basis of whether the authors received industry funding as well as study design. We tested for small-study bias when analyses included at least 9 studies using funnel plots and Egger’s regression test.28 

Two reviewers independently judged the certainty of the body of evidence for each meta-analytic comparison by following the Grading of Recommendations Assessment, Development and Evaluation approach.29  Reviewers resolved disagreements by discussion.

We identified 3247 unique records, assessed the full text of 423, and included a total of 106 studies (reported in 109 publications)30138 ; 70 of these studies (reported in 73 publications) contributed to the quantitative synthesis (Fig 1; excluded studies in Supplemental Information).*

FIGURE 1

Flow of records through the selection process.

FIGURE 1

Flow of records through the selection process.

Table 2 provides a summary of the characteristics of the included studies (study-level details are available in Supplemental Table 9). The included studies reported on a total of 7820 (median 56; range 5–400) participants, and more than two-thirds were RCTs (n = 73 of 106; 68.9%). Most studies took place in an outpatient setting (n = 81 of 106; 76.4%). The most common age group studied was children aged 2 to 11 years (n = 57 of 106; 53.8%), followed by a mix of children and teenagers (aged 2–21 years; n = 40 of 106; 37.7%). The participants were most often previously healthy children (n = 68 of 106; 64.2%). The studies reported on children with a variety of painful procedures (most commonly venipuncture [n = 32 of 106; 30.2%] or dental procedures [n = 28 of 106; 26.4%]); we located no studies reporting on acutely painful conditions. The most common digital technology distractions were traditional audiovisual aids (ie, watching a movie, cartoon, or program; n = 45 of 106; 42.5%), followed by virtual reality (n = 22 of 106; 20.8%) and audiovisual eyeglasses (ie, goggles through which children can watch television or movies; n = 22 of 106; 20.8%). In approximately half of the studies (n = 51 of 106; 48.1%), additional pharmacologic treatments for pain were provided to all study participants.

TABLE 2

Summary of the Characteristics of the Included Studies (n = 106)

Study CharacteristicStudies, n% of Total
Country of publication   
 United States 30 27.8 
 India 17 16.0 
 Italy 11 10.4 
 Australia 5.7 
 Canada 5.7 
 Iran 3.8 
 China 2.8 
 Turkey 2.8 
 Other (1–2 studies per country)a 26 24.5 
Date of publication (median 2014; range 1981–2018)   
Study design   
 RCT 73 68.9 
 Quasi RCT 3.8 
 Non-RCT 16 15.1 
 Uncontrolled before-after study 6.6 
 Time series 2.8 
 Cross-sectional 2.8 
Sources of supportb   
 Nonindustry 34 32.1 
 Industry 7.5 
 No external support 21 19.8 
 Not reported 43 40.6 
Settingb   
 Outpatient: day hospital clinic and/or ambulatory care center 42 39.6 
 Outpatient: dental clinic 27 25.5 
 Outpatient: ED 6.6 
 Outpatient: private physician’s office 3.8 
 Inpatient 26 24.5 
 Both inpatient and outpatient 1.9 
No. children (total 7820; median 56; range 5–400)   
Age category   
 Infants or toddlers (≤2 y old) 0.9 
 Children (2–11 y old) 57 53.8 
 Adolescents (12–21 y old) 2.8 
 Mixed: infant or toddler and children 4.7 
 Mixed: children and adolescents 40 37.7 
Proportion male sex (median 54%; range 0%–92%)   
Type of patient population   
 Generally healthy 68 64.2 
 Cancer or major medical diagnosis 17 16.0 
 Otherwise healthy with burns or wounds 15 14.2 
 General hospital population 5.7 
Painful procedure or conditionb   
 Venipuncture or phlebotomy 32 30.2 
 Dental anesthesia (injection) with or without dental restorationc 28 26.4 
 Intravenous cannulation 13 12.3 
 Immunization or intramuscular injection 12 11.3 
 Venous port access 6.6 
 Burn dressing change 8.5 
 Other (1–2 studies per procedure)d 14 13.2 
Type of digital technology used as distractionb   
 Audiovisual aid (watching a movie, cartoon, or television program) 45 42.5 
 Virtual reality 22 20.8 
 Audiovisual eyeglasses (watching a movie, cartoon, or scene) 22 20.8 
 Computer tablet with game apps 8.5 
 Playing a video game 6.6 
 Humanoid robot 3.8 
 Live video of the procedure 1.9 
 Handheld digital game 0.9 
Additional treatments provided for painb   
 Local anesthetics (topical and/or injected) 39 36.7 
 Analgesics: opioids 5.7 
 Analgesics: acetaminophen 4.7 
 Unspecified pharmacologic analgesia 0.9 
 Conscious sedation (benzodiazepines) 4.7 
 None reported 55 51.9 
Comparatorsb   
 Usual care control 90 84.9 
 Conventional (nondigital) distraction 16 15.1 
 Another digital technology 13 12.3 
 No comparator 7.5 
Outcomesb   
 Self-reported pain 75 70.8 
 Observer-reported pain 20 18.9 
 Behavioral measures of pain 32 30.2 
 Self-reported distress (including anxiety and fear) 31 29.2 
 Observer-reported distress 16 15.1 
 Behavioral measures of distress 21 19.8 
Study CharacteristicStudies, n% of Total
Country of publication   
 United States 30 27.8 
 India 17 16.0 
 Italy 11 10.4 
 Australia 5.7 
 Canada 5.7 
 Iran 3.8 
 China 2.8 
 Turkey 2.8 
 Other (1–2 studies per country)a 26 24.5 
Date of publication (median 2014; range 1981–2018)   
Study design   
 RCT 73 68.9 
 Quasi RCT 3.8 
 Non-RCT 16 15.1 
 Uncontrolled before-after study 6.6 
 Time series 2.8 
 Cross-sectional 2.8 
Sources of supportb   
 Nonindustry 34 32.1 
 Industry 7.5 
 No external support 21 19.8 
 Not reported 43 40.6 
Settingb   
 Outpatient: day hospital clinic and/or ambulatory care center 42 39.6 
 Outpatient: dental clinic 27 25.5 
 Outpatient: ED 6.6 
 Outpatient: private physician’s office 3.8 
 Inpatient 26 24.5 
 Both inpatient and outpatient 1.9 
No. children (total 7820; median 56; range 5–400)   
Age category   
 Infants or toddlers (≤2 y old) 0.9 
 Children (2–11 y old) 57 53.8 
 Adolescents (12–21 y old) 2.8 
 Mixed: infant or toddler and children 4.7 
 Mixed: children and adolescents 40 37.7 
Proportion male sex (median 54%; range 0%–92%)   
Type of patient population   
 Generally healthy 68 64.2 
 Cancer or major medical diagnosis 17 16.0 
 Otherwise healthy with burns or wounds 15 14.2 
 General hospital population 5.7 
Painful procedure or conditionb   
 Venipuncture or phlebotomy 32 30.2 
 Dental anesthesia (injection) with or without dental restorationc 28 26.4 
 Intravenous cannulation 13 12.3 
 Immunization or intramuscular injection 12 11.3 
 Venous port access 6.6 
 Burn dressing change 8.5 
 Other (1–2 studies per procedure)d 14 13.2 
Type of digital technology used as distractionb   
 Audiovisual aid (watching a movie, cartoon, or television program) 45 42.5 
 Virtual reality 22 20.8 
 Audiovisual eyeglasses (watching a movie, cartoon, or scene) 22 20.8 
 Computer tablet with game apps 8.5 
 Playing a video game 6.6 
 Humanoid robot 3.8 
 Live video of the procedure 1.9 
 Handheld digital game 0.9 
Additional treatments provided for painb   
 Local anesthetics (topical and/or injected) 39 36.7 
 Analgesics: opioids 5.7 
 Analgesics: acetaminophen 4.7 
 Unspecified pharmacologic analgesia 0.9 
 Conscious sedation (benzodiazepines) 4.7 
 None reported 55 51.9 
Comparatorsb   
 Usual care control 90 84.9 
 Conventional (nondigital) distraction 16 15.1 
 Another digital technology 13 12.3 
 No comparator 7.5 
Outcomesb   
 Self-reported pain 75 70.8 
 Observer-reported pain 20 18.9 
 Behavioral measures of pain 32 30.2 
 Self-reported distress (including anxiety and fear) 31 29.2 
 Observer-reported distress 16 15.1 
 Behavioral measures of distress 21 19.8 
a

Brazil (n = 1), Belgium (n = 1), Egypt (n = 2), Korea (n = 1), Mexico (n = 2), the Netherlands (n = 2), New Zealand (n = 2), Poland (n = 1), Saudi Arabia (n = 1), Singapore (n = 1), Spain (n = 2), Sweden (n = 2), Switzerland (n = 1), Syria (n = 1), the United Kingdom (n = 2), United Arab Emirates (n = 1), Taiwan (n = 1), and Thailand (n = 2).

b

Totals are >100% because some studies had >1 source of support, occurred in >1 setting, applied >1 intervention and/or comparison group, and reported on multiple outcomes.

c

Five studies focused on distraction for dental anesthetic injection only. Dental restoration was performed but was not the focus of these studies. Two studies focused on dental restoration or extraction without anesthetic injection.

d

Insertion of a venous catheter (n = 2), burn hydrotherapy (n = 2), burn physiotherapy (n = 2), genital or colposcopic examination (n = 2), wound dressing change (n = 2), lumbar puncture (n = 1), sutures (n = 1), removal of a foreign body (n = 1), and voiding cystourethrogram (n = 1).

Supplemental Tables 10 through 13 show the detailed risk-of-bias judgments for the included studies. We judged the overall risk of bias to be high among all studies. Common sources of potential bias included a lack of blinding, inadequate randomization and allocation concealment, the use of crossover designs, block randomization in unblinded trials, baseline imbalances, and a lack of control groups in the observational studies.

Table 3 presents the summary of findings for each meta-analysis by outcome (see the Supplemental Information for all forest plots); within this table, we have also reexpressed SMDs on common scales for ease of interpretation. Table 4 provides a summary of findings for studies not included in the meta-analyses because of design (not an RCT or quasi RCT) or a lack of suitable data. In most cases, the findings of these studies did not differ substantially from the results of the meta-analyses. Table 5 shows the findings from additional comparisons that involved only 1 study each as well as studies without a comparator.

TABLE 3

Summary of Findings for Each Outcome of Interest Across the 4 Comparisons Examined via Meta-analysis

OutcomeChildren, n (RCTs)Anticipated Absolute Effects, SMD or MD (95% CI)aCertainty of Evidence (GRADE)SMD Reexpressed on a Common Scale, MD (95% CI)bRelative Difference
Any digital technology versus usual care      
 Self-reported pain: varied scales 3200 (46) SMD: −0.48 (−0.66 to −0.29) Very lowc,d Wong-Baker Faces Pain Scale (0–10): −1.02 (−1.40 to −0.61) 9% lower with digital technology 
 Observer-reported pain: varied scales 1199 (17) SMD: −0.68 (−0.91 to −0.45) Lowc,e Visual Analogue Scale (0–10): −1.82 (−2.43 to −1.20) 17% lower with digital technology 
 Behavioral measures of pain: varied scales 1173 (19) SMD: −0.57 (−0.94 to −0.19) Very lowc,d FLACC (0–10): −1.23 (−2.03 to −0.41) 11% lower with digital technology 
 Self-reported distress: varied scales 1818 (19) SMD: −0.49 (−0.70 to −0.27) Very lowc,d Visual Analogue Scale (0–100): −17.98 (−25.69 to −9.91) 18% lower with digital technology 
 Observer-reported distress: varied scales 826 (10) SMD: −0.47 (−0.77 to −0.17) Lowc,e Visual Analogue Scale (0–100): −10.90 (−17.86 to −3.94) 11% lower with digital technology 
 Behavioral measures of distress: varied scales 1264 (17) SMD: −0.35 (−0.59 to −0.12) Very lowc,d Groningen Distress Scale (1–5): −0.35 (−0.60 to −0.12) 7% lower with digital technology 
Any digital technology versus nondigital distractionc      
 Self-reported pain: varied scales 771 (8) SMD: −0.27 (−0.56 to 0.02) Lowc,e Wong-Baker Faces Pain Scale (0–10): −0.86 (−1.79 to −0.06) 8% lower with digital technology 
 Observer-reported pain: varied scales 181 (2) SMD: −0.66 (−1.08 to 0.23) Very lowc,f,g Wong-Baker Faces Pain Scale (0–10): −1.74 (−2.85 to 0.61) 16% lower with digital technology 
 Self-reported distress: varied scales 235 (3) SMD: −0.92 (−1.43 to −0.41) Very lowc,e,f Children’s Fear Scale (0–4): −1.33 (−2.07 to −0.59) 27% lower with digital technology 
 Observer-reported distress: varied scales 209 (3) SMD: −0.32 (−0.98 to 0.34) Very lowc,e,h Children’s Fear Scale (0–4): −0.42 (−1.28 to 0.45) 8% lower with digital technology 
 Behavioral measures of distress: varied scales 288 (4) SMD: 0.21 (−0.02 to 0.45) Very lowc,d,f mYPAS (23.33–100): 4.26 (−0.41 to 9.14) 6% lower with nondigital distraction 
Audiovisual eyeglasses versus projected movie distractiond      
 Self-reported pain: Wong-Baker Faces Pain Rating scale (0–10) 150 (2) MD: 0.01 (−2.36 to 2.39) Very lowc,d,h Not applicable Little to no difference 
Video game versus virtual reality distraction      
 Self-reported pain: varied scales 117 (3) SMD: 0.61 (−0.70 to 1.92) Very lowe,f,h Wong-Baker Faces Pain Scale (0–10): 0.93 (−1.06 to 2.92) Little to no difference 
 Observer-reported pain: varied scales 117 (3) SMD: 0.90 (−0.69 to 2.50) Very lowc,d,h Visual Analogue Scale (0–10): 2.10 (−1.51 to 5.83) Little to no difference 
 Behavioral measures of pain: varied scales 117 (3) SMD: 0.24 (−0.30 to 0.78) Very lowc,g,h FLACC (0–10): 0.53 (−0.67 to 1.73) Little to no difference 
OutcomeChildren, n (RCTs)Anticipated Absolute Effects, SMD or MD (95% CI)aCertainty of Evidence (GRADE)SMD Reexpressed on a Common Scale, MD (95% CI)bRelative Difference
Any digital technology versus usual care      
 Self-reported pain: varied scales 3200 (46) SMD: −0.48 (−0.66 to −0.29) Very lowc,d Wong-Baker Faces Pain Scale (0–10): −1.02 (−1.40 to −0.61) 9% lower with digital technology 
 Observer-reported pain: varied scales 1199 (17) SMD: −0.68 (−0.91 to −0.45) Lowc,e Visual Analogue Scale (0–10): −1.82 (−2.43 to −1.20) 17% lower with digital technology 
 Behavioral measures of pain: varied scales 1173 (19) SMD: −0.57 (−0.94 to −0.19) Very lowc,d FLACC (0–10): −1.23 (−2.03 to −0.41) 11% lower with digital technology 
 Self-reported distress: varied scales 1818 (19) SMD: −0.49 (−0.70 to −0.27) Very lowc,d Visual Analogue Scale (0–100): −17.98 (−25.69 to −9.91) 18% lower with digital technology 
 Observer-reported distress: varied scales 826 (10) SMD: −0.47 (−0.77 to −0.17) Lowc,e Visual Analogue Scale (0–100): −10.90 (−17.86 to −3.94) 11% lower with digital technology 
 Behavioral measures of distress: varied scales 1264 (17) SMD: −0.35 (−0.59 to −0.12) Very lowc,d Groningen Distress Scale (1–5): −0.35 (−0.60 to −0.12) 7% lower with digital technology 
Any digital technology versus nondigital distractionc      
 Self-reported pain: varied scales 771 (8) SMD: −0.27 (−0.56 to 0.02) Lowc,e Wong-Baker Faces Pain Scale (0–10): −0.86 (−1.79 to −0.06) 8% lower with digital technology 
 Observer-reported pain: varied scales 181 (2) SMD: −0.66 (−1.08 to 0.23) Very lowc,f,g Wong-Baker Faces Pain Scale (0–10): −1.74 (−2.85 to 0.61) 16% lower with digital technology 
 Self-reported distress: varied scales 235 (3) SMD: −0.92 (−1.43 to −0.41) Very lowc,e,f Children’s Fear Scale (0–4): −1.33 (−2.07 to −0.59) 27% lower with digital technology 
 Observer-reported distress: varied scales 209 (3) SMD: −0.32 (−0.98 to 0.34) Very lowc,e,h Children’s Fear Scale (0–4): −0.42 (−1.28 to 0.45) 8% lower with digital technology 
 Behavioral measures of distress: varied scales 288 (4) SMD: 0.21 (−0.02 to 0.45) Very lowc,d,f mYPAS (23.33–100): 4.26 (−0.41 to 9.14) 6% lower with nondigital distraction 
Audiovisual eyeglasses versus projected movie distractiond      
 Self-reported pain: Wong-Baker Faces Pain Rating scale (0–10) 150 (2) MD: 0.01 (−2.36 to 2.39) Very lowc,d,h Not applicable Little to no difference 
Video game versus virtual reality distraction      
 Self-reported pain: varied scales 117 (3) SMD: 0.61 (−0.70 to 1.92) Very lowe,f,h Wong-Baker Faces Pain Scale (0–10): 0.93 (−1.06 to 2.92) Little to no difference 
 Observer-reported pain: varied scales 117 (3) SMD: 0.90 (−0.69 to 2.50) Very lowc,d,h Visual Analogue Scale (0–10): 2.10 (−1.51 to 5.83) Little to no difference 
 Behavioral measures of pain: varied scales 117 (3) SMD: 0.24 (−0.30 to 0.78) Very lowc,g,h FLACC (0–10): 0.53 (−0.67 to 1.73) Little to no difference 

GRADE, Grading of Recommendations Assessment, Development, and Evaluation; mYPAS, modified Yale Preoperative Anxiety Scale.

a

The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

b

MDs should be interpreted with caution because the results are based on the mean control group SD for a subset of studies in the analysis that used the most commonly reported scale.

c

Downgraded 1 level for serious concerns about methodologic considerations (lack of blinding and, in some cases, other sources of bias).

d

Downgraded 2 levels for very serious concerns about inconsistency in effects across studies.

e

Downgraded 1 level for serious concerns about inconsistency in effects across studies.

f

Downgraded 1 level for serious concerns about imprecision; the sample size does not meet the optimal information size.

g

Downgraded 1 level for serious concerns about inconsistency. There is inadequate evidence of consistency because of the small number of studies.

h

Downgraded 2 levels for very serious concerns about imprecision; the sample size does not meet the optimal information size, and the CI indicates the potential for a null effect of benefit of either intervention.

TABLE 4

Findings on the Effect of Digital Technologies on Pain and Distress From Studies Not Included in the Meta-analyses (Because of Design or Lack of Suitable Data)

DesignAuthor and ynFindingsInterpretation
Any digital technology versus usual care     
 Self-reported pain     
  RCT Sharar et al 2007123  NR ↓ In 3 of 4 RCTs (n > 86), pain was lower in the digital technology versus the usual care group; 1 RCT revealed no difference between groups 
Stinley et al 2015125  40 ↔ 
Atzori et al 201836  22 ↓ 
Atzori et al 201837  24 ↓ 
Mott et al 2008105  NR ↓ 
  nRCT Chaturvedi et al 201651  40 ↓ In 7 of 9 nRCTs (n = 481), pain was lower in the digital technology versus the usual care group; 2 nRCTs revealed no difference between groups 
Cohen et al 199754  61 ↓ 
Kohli and Sobiya 201590  60 ↓ 
Hussein 2015a76  37 ↓ 
Hussein 2015b76  38 ↓ 
Lessi et al 201193  65 ↔ 
Lobo and Umarani 2013106  60 ↓ 
Nilsson et al 2009110  42 ↔ 
Piskorz 2018114  38 ↓ 
Yoo et al 2011134  40 ↓ 
  Before-after studies Bansal et al 2018a40  60 ↓ In 2 before-after (n = 128) and 2 time series (n = 72) studies in which children were their own controls, the effect of digital technologies versus usual care was equivocal 
Bansal 2018b40  60 ↓ 
Guinot Jimeno et al 201472  68 ↔ 
  Time series Kaur et al 201785  60 ↓ In 2 before-after (n = 128) and 2 time series (n = 72) studies in which children were their own controls, the effect of digital technologies versus usual care was equivocal 
van Twillert et al 2007128  12 ↔ 
 Observer-reported pain     
  nRCT Hussein 2015a76  37 ↓ In 2 nRCTs (n = 115), pain was lower in the digital technology versus the usual care group 
Hussein 2015b76  38 ↓ 
Yoo et al 2011134  40 ↓ 
 Behavioral measures of pain     
  nRCT Devi et al 201660  32 NR In 6 nRCTs (n = 499), pain was lower in the digital technology versus the usual care group; 1 nRCT showed no difference between groups, and in another, the effect was not tested statistically 
Gedam et al 201366  230 ↓ 
Gupta et al 201473  70 ↓ 
Lessi et al 2011a93  65 ↓ 
Lessi 2011b93  65 ↓ 
Maharjan et al 201798  60 ↓ 
Nilsson et al 2009110  42 ↔ 
  Before-after studies Bansal et al 2018a40  60 ↓ In 2 before-after studies (n = 110) in which children were their own controls, pain was lower in the digital technology versus the usual care group 
Bansal 2018b40  60 ↓ 
James et al 201279  50 ↓ 
 Self-reported distress     
  RCT Rickert et al 1994a116  21 ↔ In 2 RCTs (n = 98), there was no difference in distress between groups 
Rickert 1994b116  22 ↔ 
Venham et al 1981129  55 ↔ 
  nRCT Nilsson et al 2009110  42 ↔ In 2 of 3 nRCTs (n = 120), there was no difference in distress between groups 
Piskorz and Czub 2018114  38 ↓ 
Prabhakar et al 2007115  40 ↔ 
  Before-after studies Bansal et al 2018a40  60 ↔ In 1 of the 2 before-after (n = 128) and 2 time series (n = 34) studies in which children were their own controls, there was no difference in distress between groups; 1 study found lesser distress among 8–10 y olds in the digital technology versus the usual care group 
Bansal 2018b40  60 ↓ 
Guinot Jimeno et al 201472  68 ↔ 
  Time series Schneider and Workman 1999121  22 ↔ In 1 of the 2 before-after (n = 128) and 2 time series (n = 34) studies in which children were their own controls, there was no difference in distress between groups; 1 study found lesser distress among 8–10 y olds in the digital technology versus the usual care group 
van Twillert et al 2007128  12 ↔ 
 Observer-reported distress     
  RCT Venham et al 1981129  55 ↔ No difference between groups 
  nRCT Sullivan et al 2000126  60 ↔ No difference between groups 
  Cross-sectional Shahid et al 2015122  103 ↔ No difference between groups 
 Behavioral measures of distress     
  RCT Windich-Biermeier et al 2007131  50 ↔ No difference between groups 
  nRCT Cohen et al 199754  61 ↓ Lower distress in the digital technology group 
  Time series Kaur et al 201785  60 ↓ Lower distress in the digital technology group 
Any digital technology versus conventional (nondigital) distraction     
 Behavioral measures of pain     
  RCT Nilsson et al 2013109  40 ↓ Lower pain in the digital technology group 
  nRCT Gedam et al 201366  240 ↑ In 2 nRCTs (n = 278), the effect of digital technologies versus usual care was equivocal 
Knight et al 201889  38 ↓ 
 Self-reported distress     
  nRCT Prabhakar et al 2007115  40 ↔ No difference between groups 
 Behavioral measures of distress    
  RCT Berenson et al 1998a43  46 ↔ No difference between digital technology versus active play groups but lower distress in the digital technology group versus passive play 
Berenson 1998b43  43 ↓ 
  nRCT Knight et al 201889  38 ↔ No difference between groups 
DesignAuthor and ynFindingsInterpretation
Any digital technology versus usual care     
 Self-reported pain     
  RCT Sharar et al 2007123  NR ↓ In 3 of 4 RCTs (n > 86), pain was lower in the digital technology versus the usual care group; 1 RCT revealed no difference between groups 
Stinley et al 2015125  40 ↔ 
Atzori et al 201836  22 ↓ 
Atzori et al 201837  24 ↓ 
Mott et al 2008105  NR ↓ 
  nRCT Chaturvedi et al 201651  40 ↓ In 7 of 9 nRCTs (n = 481), pain was lower in the digital technology versus the usual care group; 2 nRCTs revealed no difference between groups 
Cohen et al 199754  61 ↓ 
Kohli and Sobiya 201590  60 ↓ 
Hussein 2015a76  37 ↓ 
Hussein 2015b76  38 ↓ 
Lessi et al 201193  65 ↔ 
Lobo and Umarani 2013106  60 ↓ 
Nilsson et al 2009110  42 ↔ 
Piskorz 2018114  38 ↓ 
Yoo et al 2011134  40 ↓ 
  Before-after studies Bansal et al 2018a40  60 ↓ In 2 before-after (n = 128) and 2 time series (n = 72) studies in which children were their own controls, the effect of digital technologies versus usual care was equivocal 
Bansal 2018b40  60 ↓ 
Guinot Jimeno et al 201472  68 ↔ 
  Time series Kaur et al 201785  60 ↓ In 2 before-after (n = 128) and 2 time series (n = 72) studies in which children were their own controls, the effect of digital technologies versus usual care was equivocal 
van Twillert et al 2007128  12 ↔ 
 Observer-reported pain     
  nRCT Hussein 2015a76  37 ↓ In 2 nRCTs (n = 115), pain was lower in the digital technology versus the usual care group 
Hussein 2015b76  38 ↓ 
Yoo et al 2011134  40 ↓ 
 Behavioral measures of pain     
  nRCT Devi et al 201660  32 NR In 6 nRCTs (n = 499), pain was lower in the digital technology versus the usual care group; 1 nRCT showed no difference between groups, and in another, the effect was not tested statistically 
Gedam et al 201366  230 ↓ 
Gupta et al 201473  70 ↓ 
Lessi et al 2011a93  65 ↓ 
Lessi 2011b93  65 ↓ 
Maharjan et al 201798  60 ↓ 
Nilsson et al 2009110  42 ↔ 
  Before-after studies Bansal et al 2018a40  60 ↓ In 2 before-after studies (n = 110) in which children were their own controls, pain was lower in the digital technology versus the usual care group 
Bansal 2018b40  60 ↓ 
James et al 201279  50 ↓ 
 Self-reported distress     
  RCT Rickert et al 1994a116  21 ↔ In 2 RCTs (n = 98), there was no difference in distress between groups 
Rickert 1994b116  22 ↔ 
Venham et al 1981129  55 ↔ 
  nRCT Nilsson et al 2009110  42 ↔ In 2 of 3 nRCTs (n = 120), there was no difference in distress between groups 
Piskorz and Czub 2018114  38 ↓ 
Prabhakar et al 2007115  40 ↔ 
  Before-after studies Bansal et al 2018a40  60 ↔ In 1 of the 2 before-after (n = 128) and 2 time series (n = 34) studies in which children were their own controls, there was no difference in distress between groups; 1 study found lesser distress among 8–10 y olds in the digital technology versus the usual care group 
Bansal 2018b40  60 ↓ 
Guinot Jimeno et al 201472  68 ↔ 
  Time series Schneider and Workman 1999121  22 ↔ In 1 of the 2 before-after (n = 128) and 2 time series (n = 34) studies in which children were their own controls, there was no difference in distress between groups; 1 study found lesser distress among 8–10 y olds in the digital technology versus the usual care group 
van Twillert et al 2007128  12 ↔ 
 Observer-reported distress     
  RCT Venham et al 1981129  55 ↔ No difference between groups 
  nRCT Sullivan et al 2000126  60 ↔ No difference between groups 
  Cross-sectional Shahid et al 2015122  103 ↔ No difference between groups 
 Behavioral measures of distress     
  RCT Windich-Biermeier et al 2007131  50 ↔ No difference between groups 
  nRCT Cohen et al 199754  61 ↓ Lower distress in the digital technology group 
  Time series Kaur et al 201785  60 ↓ Lower distress in the digital technology group 
Any digital technology versus conventional (nondigital) distraction     
 Behavioral measures of pain     
  RCT Nilsson et al 2013109  40 ↓ Lower pain in the digital technology group 
  nRCT Gedam et al 201366  240 ↑ In 2 nRCTs (n = 278), the effect of digital technologies versus usual care was equivocal 
Knight et al 201889  38 ↓ 
 Self-reported distress     
  nRCT Prabhakar et al 2007115  40 ↔ No difference between groups 
 Behavioral measures of distress    
  RCT Berenson et al 1998a43  46 ↔ No difference between digital technology versus active play groups but lower distress in the digital technology group versus passive play 
Berenson 1998b43  43 ↓ 
  nRCT Knight et al 201889  38 ↔ No difference between groups 

NR, not reported; nRCT, nonrandomized controlled trial; ↓, pain or distress significantly lower in the intervention group; ↔, no significant difference between groups; ↑, pain or distress significantly higher in the intervention group.

TABLE 5

Findings on the Effect of Digital Technologies on Pain and Distress for Comparisons That Were Not Meta-analyzed and Studies Without a Comparator

Author and yDesignnInterventionComparatorFindings
Self-reported pain      
 Attar and Baghdadi 201535  RCT 78 Tablet (game app) AV eyeglasses ↔ 
 Inan and Inal 201877  RCT 90 Tablet (game app) AV aid (cartoon) ↓ 
 Jeffs et al 201480  RCT 18 Virtual reality AV aid (movie) ↓ 
 Hussein 201576  nRCT 50 Tablet (game app) AV aid (cartoon) ↓ 
 Ali et al 201415  Before-after study 30 Video game None Pain decreased over time while the device was being used 
 Juarez García et al 201882  Before-after study 13 Tablet (game app) None 11 children rated pain as mild or absent; 2 rated pain as moderate 
 Chad et al 201749  Before-after study 15 AV eyeglasses None No difference between anticipated and actual reported pain 
 Sonne et al 2017124  Before-after study 10 AV aid (movie) None Reported pain was not different from expected pain 
 Bagnasco et al 201239  Cross-sectional 203 AV aid (cartoon) None Pain score seemed lower than reports in the literature when no AV aid was used 
 Jibb et al 201881  RCT (1 arm) 21 Humanoid robot None Mean pain during the procedure was 1.4 (SD 3.0) on a scale of 0 (no pain) to 10 
Observer-reported pain      
 Inan and Inal 201877  RCT 90 Tablet (game app) AV aid (cartoon) ↔ 
 Chad 201749  Before-after study 17 AV eyeglasses None Observed pain was lower than the anticipated pain reported by the observer 
 Sonne et al 2017124  Before-after study 19 AV aid (movie) None Reported pain was not different from expected pain 
Behavioral measures of pain      
 Al-Halabi et al 201831  RCT 68 AV eyeglasses (movie) AV aid (movie) ↔ 
 Rickert et al 1994116  RCT 28 Live video of procedure AV aid (cartoon or movie) Pain seemed lower in the live video group, but was not tested statistically 
 Khadra et al 201886  Before-after study 15 Virtual reality dome None No difference in pain scores before, during, or after the procedure; pain tended to be either minor or severe 
 Juarez García et al 201882  Before-after study 25 Tablet (game app) None 22 children had minor or moderate pain; 5 had no pain 
 Bagnasco et al 201239  Cross-sectional 203 AV aid (cartoon) None Pain score seemed lower than reports in the literature when no AV aid was used 
 Chau et al 201852  Cross-sectional 13 Virtual reality None 9 patients had a positive experience (mean FLACC score of 2.5 (IQR 1–5.5); others had a neutral or negative experience 
Self-reported distress      
 Fakhruddin et al 201563  RCT 60 Projected movie AV eyeglasses Pain was reduced when the video eyewear was used in the second session in a series (versus projected movie); no difference was found when the opposite sequence was used 
 Gershon et al 2004137  RCT 37 Virtual reality Video game ↓ 
 Inan and Inal 201877  RCT 90 Tablet (game app) AV aid (cartoon) ↓ 
 MacLaren and Cohen 200597  Quasi RCT 59 Robot or video game AV aid (movie) ↔ 
 Rickert et al 1994116  RCT 28 Live video of procedure AV aid (music video) ↔ 
 Yasemin et al 2018133  RCT 200 Robot (iRobi) Robot (Nao) Distress appears similar but was not tested statistically 
 Chad et al 201749  Before-after study 15 AV eyeglasses None No difference between anticipated and actual reported fear 
 Sonne et al 2017124  Before-after study 19 AV aid (cartoon or movie) None No difference in fear before and after the procedure 
Observer-reported distress      
 Gershon et al 2004137  RCT 44 Virtual reality Video game ↔ 
 Inan and Inal 201877  RCT 90 Tablet (game app) AV aid (cartoon) ↓ 
 MacLaren and Cohen 200597  Quasi RCT 59 Robot or video game AV aid (movie) ↔ 
 Chad et al 201749  Before-after study 17 AV eyeglasses None Observed fear was lower than the anticipated fear reported by the observer 
 Sonne et al 2017124  Before-after study 19 AV aid (cartoon or movie) None No difference in fear before and after the procedure 
Behavioral measures of distress      
 MacLaren and Cohen 200597  Quasi RCT 59 Robot or video game AV aid (movie) ↔ 
 Jibb et al 201891  RCT 21 Humanoid robot None Mean ratings of distress were low for all procedural steps (ie, 1.3–2.3 out of 5) 
 Khadra et al 201886  Before-after study Virtual reality dome None There was no difference in anxiety at any time during the procedure 
Author and yDesignnInterventionComparatorFindings
Self-reported pain      
 Attar and Baghdadi 201535  RCT 78 Tablet (game app) AV eyeglasses ↔ 
 Inan and Inal 201877  RCT 90 Tablet (game app) AV aid (cartoon) ↓ 
 Jeffs et al 201480  RCT 18 Virtual reality AV aid (movie) ↓ 
 Hussein 201576  nRCT 50 Tablet (game app) AV aid (cartoon) ↓ 
 Ali et al 201415  Before-after study 30 Video game None Pain decreased over time while the device was being used 
 Juarez García et al 201882  Before-after study 13 Tablet (game app) None 11 children rated pain as mild or absent; 2 rated pain as moderate 
 Chad et al 201749  Before-after study 15 AV eyeglasses None No difference between anticipated and actual reported pain 
 Sonne et al 2017124  Before-after study 10 AV aid (movie) None Reported pain was not different from expected pain 
 Bagnasco et al 201239  Cross-sectional 203 AV aid (cartoon) None Pain score seemed lower than reports in the literature when no AV aid was used 
 Jibb et al 201881  RCT (1 arm) 21 Humanoid robot None Mean pain during the procedure was 1.4 (SD 3.0) on a scale of 0 (no pain) to 10 
Observer-reported pain      
 Inan and Inal 201877  RCT 90 Tablet (game app) AV aid (cartoon) ↔ 
 Chad 201749  Before-after study 17 AV eyeglasses None Observed pain was lower than the anticipated pain reported by the observer 
 Sonne et al 2017124  Before-after study 19 AV aid (movie) None Reported pain was not different from expected pain 
Behavioral measures of pain      
 Al-Halabi et al 201831  RCT 68 AV eyeglasses (movie) AV aid (movie) ↔ 
 Rickert et al 1994116  RCT 28 Live video of procedure AV aid (cartoon or movie) Pain seemed lower in the live video group, but was not tested statistically 
 Khadra et al 201886  Before-after study 15 Virtual reality dome None No difference in pain scores before, during, or after the procedure; pain tended to be either minor or severe 
 Juarez García et al 201882  Before-after study 25 Tablet (game app) None 22 children had minor or moderate pain; 5 had no pain 
 Bagnasco et al 201239  Cross-sectional 203 AV aid (cartoon) None Pain score seemed lower than reports in the literature when no AV aid was used 
 Chau et al 201852  Cross-sectional 13 Virtual reality None 9 patients had a positive experience (mean FLACC score of 2.5 (IQR 1–5.5); others had a neutral or negative experience 
Self-reported distress      
 Fakhruddin et al 201563  RCT 60 Projected movie AV eyeglasses Pain was reduced when the video eyewear was used in the second session in a series (versus projected movie); no difference was found when the opposite sequence was used 
 Gershon et al 2004137  RCT 37 Virtual reality Video game ↓ 
 Inan and Inal 201877  RCT 90 Tablet (game app) AV aid (cartoon) ↓ 
 MacLaren and Cohen 200597  Quasi RCT 59 Robot or video game AV aid (movie) ↔ 
 Rickert et al 1994116  RCT 28 Live video of procedure AV aid (music video) ↔ 
 Yasemin et al 2018133  RCT 200 Robot (iRobi) Robot (Nao) Distress appears similar but was not tested statistically 
 Chad et al 201749  Before-after study 15 AV eyeglasses None No difference between anticipated and actual reported fear 
 Sonne et al 2017124  Before-after study 19 AV aid (cartoon or movie) None No difference in fear before and after the procedure 
Observer-reported distress      
 Gershon et al 2004137  RCT 44 Virtual reality Video game ↔ 
 Inan and Inal 201877  RCT 90 Tablet (game app) AV aid (cartoon) ↓ 
 MacLaren and Cohen 200597  Quasi RCT 59 Robot or video game AV aid (movie) ↔ 
 Chad et al 201749  Before-after study 17 AV eyeglasses None Observed fear was lower than the anticipated fear reported by the observer 
 Sonne et al 2017124  Before-after study 19 AV aid (cartoon or movie) None No difference in fear before and after the procedure 
Behavioral measures of distress      
 MacLaren and Cohen 200597  Quasi RCT 59 Robot or video game AV aid (movie) ↔ 
 Jibb et al 201891  RCT 21 Humanoid robot None Mean ratings of distress were low for all procedural steps (ie, 1.3–2.3 out of 5) 
 Khadra et al 201886  Before-after study Virtual reality dome None There was no difference in anxiety at any time during the procedure 

AV, audiovisual; IQR, interquartile range; nRCT, nonrandomized controlled trial; ↓, pain or distress significantly lower in the intervention group; ↔, no significant difference between groups; ↑, pain or distress significantly higher in the intervention group.

Pain

Compared with usual care, the use of digital technology distraction may result in a modest but clinically important reduction in pain for children undergoing painful procedures. We observed a small reduction in self-reported pain (SMD −0.48; 95% CI −0.66 to −0.29; I2 = 72%; 46 RCTs; 2609 children; very low certainty), moderate reduction in observer-reported pain (SMD −0.68; 95% CI −0.91 to −0.45; I2 = 83%; 17 RCTs; 1199 children; low certainty), and small reduction in behavioral measures of pain (SMD −0.57; 95% CI −0.94 to −0.19; I2 = 89%; 19 RCTs; 1173 children; very low certainty)§ with digital technologies.

Distress

Compared with usual care, the use of digital technology distraction may result in a modest but clinically important reduction in distress, as reported by children undergoing painful procedures and their observers (eg, caregivers and health care providers). We observed a moderate reduction in self-reported distress (SMD −0.49; 95% CI −0.70 to −0.27; I2 = 78%; 19 RCTs; 1818 children; very low certainty)|| and a small reduction observer-reported distress (SMD −0.47; 95% CI −0.77 to −0.17; I2 = 73%; 10 RCTs; 826 children, low certainty) with digital technology. The reduction in behavioral distress observed was small and potentially not clinically important (SMD −0.35; 95% CI −0.59 to −0.12; I2 = 72%; 17 RCTs; 1264 children; very low certainty).#

Subgroup and Sensitivity Analyses

Within-study analyses by age (n = 31)** and/or sex (n = 25)†† generally showed little to no difference in pain or distress scores; when a difference was noted, in most cases, younger children and girls experienced more pain and/or distress than did older children and boys.

When assessed by using behavioral measures of pain (eg, Face, Legs, Activity, Cry, Consolability scale [FLACC]), digital technology with active distraction (ie, requiring child engagement) resulted in reduced pain compared with usual care (SMD −0.92; 95% CI −1.52 to −0.31; I2 = 95%; 6 RCTs; 387 children), but there was little to no effect for passive distraction (SMD −0.06; 95% CI −0.27 to 0.14; I2 = 22%; 8 RCTs; 492 children). Sensitivity analyses showed no significant change in effects with the removal of quasi RCTs and crossover trials or industry-funded studies except for behavioral measures of pain, for which the effect for industry-funded studies appeared to be slightly greater (SMD −0.13; 95% CI −0.58 to 0.31; I2 = 59%; 4 RCTs; 207 children) than for nonindustry-funded studies (SMD −0.05; 95% CI −0.30 to 0.20; I2 = 30%; 6 RCTs; 384 children). We did not detect small-study bias.

Pain

Compared with nondigital distractors, the use of digital technology may result in a modest but clinically important reduction in pain for children undergoing painful procedures. We observed a small reduction in self-reported pain (SMD −0.27; 95% CI −0.56 to 0.02; I2 = 71%; 8 RCTs; 771 children; low certainty)‡‡ and moderate reduction in observer-reported pain (SMD −0.66; 95% CI −1.08 to 0.23; I2 = 45%; 2 RCTs; 181 children; very low certainty)41,77  with digital technology. However, the evidence for these outcomes was uncertain, and CIs included the potential for little to no difference. There were no data available for meta-analysis for the behavioral pain outcome.

Distress

When compared with nondigital distraction, the impact of digital technology on distress among children undergoing painful procedures is unclear. We observed a moderate reduction in self-reported distress (SMD −0.92; 95% CI −1.43 to −0.41; I2 = 69%; 3 RCTs; 235 children; very low certainty)77,109,111  with digital technology. Observer-reported distress was slightly higher for children distracted by digital technology compared with nondigital distractors (SMD −0.32; 95% CI −0.98 to 0.34; I2 = 78%; 3 RCTs; 209 children; very low certainty),77,94,99  but this effect was very uncertain, and the CI included the potential for no important difference. Behavioral measures of distress were reduced in children distracted with nondigital distractors compared with digital ones, but the difference was small enough that it may not be clinically important (SMD 0.21; 95% CI −0.02 to 0.45; I2 = 0%; 4 RCTs; 288 children; very low certainty).48,91,94,99 

Subgroup and Sensitivity Analyses

One study commented on within-study differences in pain by age and sex, finding no difference between groups.41  The small number of included studies for each comparison hindered our ability to identify any credible between-study subgroup differences. One RCT (n = 89) excluded from the meta-analysis showed no difference when comparing digital technologies to active nondigital distraction (ie, singing or blowing bubbles) but favored digital technology when compared with passive nondigital distraction (ie, being read a fairy tale),43  whereas another nonrandomized study showed little to no difference between groups.89  Sensitivity analyses showed no significant change in effects with the removal of quasi RCTs and crossover trials or industry-funded studies. Small-study bias was not detected.

Pain and Distress

The findings of 2 studies showed no important difference in self-reported pain for distraction via audiovisual eyeglasses compared with a projected movie during minor dental procedures (MD 0.01; 95% CI −2.36 to 2.39; I2 = 99%; 2 RCTs; 150 children; very low certainty).63,64  No other outcomes of interest were available in these studies.

Three RCTs (n = 117) examined distraction by using video games compared with virtual reality (2 for needle-related procedures and 1 for burn dressing changes).68,101,102,137  The CIs for these analyses were wide; thus, it was impossible to determine with any certainty whether any clinically important differences in self-reported, observer-reported, or behavioral pain might exist between the interventions.68,101,102,137  No distress-related outcomes were reported.

Subgroup and Sensitivity Analyses

The small number of included studies for each comparison hindered our ability to identify between-study subgroup differences, perform sensitivity analyses, or test for small-study bias.

There is a large and rapidly accumulating body of evidence exploring the use of digital technology distractors for children’s pain and distress during painful medical procedures (especially needle-related procedures, minor dental procedures, and burn treatments) when compared with usual care. We identified no studies reporting on acutely painful conditions. On the basis of the included studies, distraction appears to have a positive effect on both pain and distress, but digital technology does not seem to confer an obvious advantage over nondigital distractors. Certainty in the evidence ranged from low to very low, driven largely by risk of bias and inconsistency in effect estimates. More head-to-head trials are needed to clarify which type of distraction might work best, for which children and procedure, and in what setting.

There is little consensus in the literature on how to define a clinically significant difference in pain.139  On the basis of available literature,101,140,141  the reductions in pain associated with use of digital technology distractors may be considered clinically important (estimated between 10% and 20% on commonly used scales), although CIs were sometimes wide (including small effects). Large, high-quality trials are needed to improve the precision of current effect estimates. We did not specifically investigate the occurrence of adverse events, but these seemed to be limited to mild “simulator sickness” from virtual reality devices.120,123  Knowing that inadequate pain management can have both short- and long-term consequences for children,2,7  the potential for small to moderate reductions in pain and distress in the presence of what appears to be minimal risk supports the use of digital technology distraction for children and teenagers undergoing acutely painful procedures. Given proposed mechanisms,17,142  it seems plausible that digital technology distraction could be beneficial for children with acutely painful conditions, but this cannot be confirmed by our review. Understanding the potential value of digital technology distraction for acutely painful conditions should be a future research focus given the ubiquitous nature of this presentation.

Evidence from our meta-analyses showed little to no difference in the effect of various digital technologies on pain compared with nondigital distractors; there was a possible greater effect on distress reduction with digital technologies, but this was supported by only 3 trials. Similarly, a 2018 Cochrane Review on the effect of both digital (eg, watching cartoons or movies and using handheld video games) and nondigital (eg, music, playing with a toy, and presence of a medical clown) distraction on pain during needle procedures showed that a variety of distractors are likely to be equally effective.13  Although we focused on digital distraction, our findings extend those of Birnie et al’s13  recent systematic review, which showed that distraction works, but it is unclear which type of distraction is best suited for children on the basis of age, stage of development, or clinical setting. In the absence of concrete empirical evidence, health care providers should focus on implementing the type of distraction that is most feasible in their particular setting while taking into account the needs of their patient population (eg, child preference, type of procedure, and available resources and time).

Feasibility and resources should be taken into account when deciding whether to implement digital technology distractors. The purchase of digital devices can be costly, as is the replacement of damaged devices or upgrades for novel technologies that may rapidly become out of date. However, digital technologies (eg, virtual reality, tablets, and humanoid robots) may offer some unique advantages compared with nondigital distractions (eg, bubbles, reading a story, and puppets). Many digital technology distractions require little if any training to implement. Many families commonly have access to their own portable handheld devices (eg, smartphones and tablets), which can be used for various forms of distraction (eg, game applications [apps] and videos),143  and their use avoids important infection control issues that are of critical importance in health care settings. Distraction provided by virtual reality and humanoid robots might offer the most novel and immersive experience,144,145  at least for children using them infrequently. A few individual studies from our review suggest that active forms of distraction (eg, video games and virtual reality) might be more effective than passive distraction (eg, cartoons and movies),76,77,80  but this is not yet firmly established.31,35 

Although evidence on the use of digital technologies is rapidly accumulating, many of the included studies were likely underpowered to detect statistically significant differences. An essentially insurmountable weakness is that it is impossible to blind children and personnel to the intervention. This should not overshadow the other prevalent methodologic and reporting deficiencies that trialists could address (eg, inadequate description of allocation concealment, baseline imbalances, crossover effects, and heterogeneity in outcome assessment tools). To improve the quality of future research, we suggest that trialists consult established guidance (eg, Consolidated Standards of Reporting Trials146  and the Standards for Research in Child Health147 ) during trial planning and conduct. In addition, consideration of the recommendations of the Pediatric Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials148  regarding standardization of outcome measures will facilitate the synthesis of findings across studies. The inclusion of head-to-head comparisons and/or within-study subgroup analyses (eg, by age, sex, type of procedure, type of distractor, setting) would provide valuable information on the applicability of the findings to particular patient groups.

The review was limited by the quality of the included studies. Generalization of the findings to young children (eg, toddlers) should be made cautiously because we found few studies for these populations. It is not possible to generalize the findings to children with acutely painful conditions at this time.

The findings of this review have important clinical and research implications. Health care providers should strongly consider digital technology and other forms of distraction as a pain- and distress-reduction strategy for children and teenagers during common painful procedures (eg, venipuncture, minor dental procedures, and burn treatments). In the absence of sufficient data to make recommendations for specific distractors or populations, health care providers should choose distractors that are feasible to implement in their setting and desirable to the individual. Because of a lack of evidence, it is not possible at this time to know whether digital technology distraction would be a useful strategy to reduce pain and distress among children with acutely painful conditions. Research efforts should be focused on the planning of large, adequately powered trials that will contribute meaningfully to clinical recommendations.

We thank MacKinna Hauff for article retrieval.

Dr Gates contributed to the conception and design of the review, collected, analyzed, and interpreted data, and drafted the initial version of the manuscript; Dr Hartling contributed to the conception and design of the review, provided methodologic expertise, interpreted the findings, and critically reviewed the draft manuscript for important intellectual content; Ms Shilhan-Kilroy, Ms MacGregor, and Ms Guitard collected and interpreted data and critically reviewed the draft manuscript for important intellectual content; Ms Wingert interpreted the findings, performed assessments of the certainty of evidence, and critically reviewed the draft manuscript for important intellectual content; Ms Featherstone planned and executed the search strategies, assisted in record management, and critically reviewed the draft manuscript for important intellectual content; Mr Vandermeer verified and analyzed data, interpreted findings, and critically reviewed the draft manuscript for important intellectual content; Drs Poonai, Kircher, Graham, Scott, and Ali and Ms Perry contributed to the conception and design of the review, provided clinical expertise, interpreted the findings, and critically reviewed the draft manuscript for important intellectual content; and all authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.

The data pertaining to this research are available from the corresponding author on reasonable request.

This review has been registered with the International Prospective Register of Systematic Reviews (https://www.crd.york.ac.uk/prospero/) (identifier CRD42017077622).

FUNDING: Funded by a Women and Children’s Health Research Institute Innovation Grant and the Alberta Strategy for Patient-Oriented Research SUPPORT (Support for People and Patient-Oriented Research and Trials) Unit Knowledge Translation Platform, which is funded by Alberta Innovates and the Canadian Institutes of Health Research.

*

Refs 3034,36,38,41,42,4448,50,53,5559,6165,6771,74,75,77,78,80,83,84,87,88,91,92,9597,99105,107109,111113,116120,125,127,130133,135138.

Refs 53,55,58,68,71,77,95,97,99,131,136,137.

**

Refs 3942,48,5355,58,71,72,74,76,79,80,85,9092,96,100102,106,108,120,123,127,129,132,134136.

‡‡

Refs 41,48,57,77,94,109,111,130.

     
  • App

    application

  •  
  • CADTH

    Canadian Agency for Drugs and Technologies in Health

  •  
  • CI

    confidence interval

  •  
  • CINAHL

    Cumulative Index to Nursing and Allied Health Literature

  •  
  • EBSCOhost

    Elton B. Stephens Co. host

  •  
  • ED

    emergency department

  •  
  • FLACC

    Face, Legs, Activity, Cry, Consolability scale

  •  
  • MD

    mean difference

  •  
  • RCT

    randomized controlled trial

  •  
  • SMD

    standardized mean difference

  •  
  • TRIP

    Turning Research Into Practice

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Competing Interests

POTENTIAL CONFLICT OF INTEREST: Drs Hartling, Graham, Scott, and Ali and Mr Vandermeer are authors on 1 of the included studies; the other authors have indicated they have no potential conflicts of interest to disclose.

FINANCIAL DISCLOSURE: Dr Hartling is a Tier I Canada Research Chair in Knowledge Synthesis and Translation. Dr Scott is a Tier II Canada Research Chair for Knowledge Translation in Child Health; the other authors have indicated they have no financial relationships relevant to this article to disclose.

Supplementary data