Benefits to Clinicians of Nonpharmacological Distraction During Pediatric Medical Procedure Free

We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines for reporting this meta-analysis of randomized controlled trials (RCTs). The study protocol was registered with the International Prospective Register of systematic reviews at the National Institute for Health Research and the Centre for Reviews and Dissemination at the University of York (CRD42021284456).

The inclusion criteria for trials in this review were as follows: (1) study design: RCT (only RCTs were included in this study because of insufficient confounding adjustment in observational studies); (2) population: children aged 1 month to 18 years undergoing medical procedures; (3) setting: inpatient and outpatient; (4) interventions and control: patients in the intervention group received NPD, whereas patients in the control group who had undergone medical procedures were not subjected to NPD (standard care without NPD); (5) primary outcomes (number of medical staff, procedure time, and initial success rate of venipuncture); and (6) publication type: full text, peer-reviewed articles published in the English language after January 1, 2010. We chose year 2010 and later because of the rapid advancements of digital devices and possible associated change in NPDs over the last decade.

We defined medical procedures as invasive procedures (eg, needle-related procedures, wound care procedures, fracture fixation, sutures, and diagnostic imaging) performed in routine practice.^8,9  NPD was defined as an intervention that can be easily and quickly implemented (eg, music, visual distraction, toys, and parent coaching).^7,9 

Study exclusion criteria includes (1) study design: crossover trials and with-in trials; (2) populations: patients presenting with critical conditions, developmental delays, visual impairments, and hearing impairments and neonates; (3) setting: surgical settings with need for anesthesia, NICU, or ICU and dental care; (4) interventions: those that required more staff, special staff such as a child life specialist, or staff that were difficult to obtain (eg, cognitive behavior, such as a medical clown or hypnosis)¹⁰ ; and (5) outcome: study outcomes did not include the primary outcome of this review.

We searched the Medline, Embase, CENTRAL, PsycInfo, and CINAHL databases up to March 2023. MeSH terms and free text words describing the use of medical procedures (eg, “needle-related procedures,” “wound care procedures,” “fracture fixation,” “ultrasonography,” “radiologic examination,” “endoscopy,” and “electrocardiogram”), NPD (eg, “parent coaching,” “audiovisual distraction,” including tablets, videos, virtual reality [VR], and toys), “child,” and “RCT” were used. It should be noted that because we focused on these search terms in our study and studies that did not include primary outcome were excluded, some studies that were eligible for inclusion may have been excluded.

In the search phase, the database was searched without language restrictions. Our search strategy was developed and assessed by 3 experienced medical information specialists from the National Center for Child Health and Development (Supplement 1). We used EndNote (version ×9; with Clarivate Analytics, Philadelphia, PA, USA) to manage records and remove duplicates and citations of trial registries and citations with the word “review” in the title before screening.

First, 2 of the 5 reviewers (S.U., T.M.,) independently screened the titles and abstracts from the database searches for inclusion in the review. Thereafter, full-text articles were obtained and assessed by 2 of 4 reviewers (S.U., T.M.) to determine eligibility. Discrepancies were resolved through discussion with a third reviewer. The Rayyan software (QCRI, Doha, Qatar; http://rayyan.qcri.org) was used for screening.

Data collection was independently performed by 2 of 3 review authors from eligible studies using forms designed by the authors. Extracted data included the study setting, participants’ demographics, type of medical procedure, details of the intervention and control arms, and outcomes. Regarding the outcome data, the unit of procedure time was unified in seconds. If the data extracted by 1 reviewer conflicted with the data extracted by the other, the disagreement was resolved by discussion or consultation with a third reviewer. If the included studies did not provide sufficient data for the meta-analysis, we contacted the study authors.

Risk of bias was independently assessed by 2 of 3 authors using the Cochrane Collaboration (Oxford, United Kingdom)’s RCT Risk of Bias Tool with regard to the following domains: bias arising from the randomization process, bias owing to deviations from intended interventions, bias caused by missing outcome data, bias in measurement of the outcome, and bias in selection of the reported result. Differences were resolved by consensus and consultation with a third reviewer.

The meta-analysis was performed using RevMan (version 5.4; The Cochrane Collaboration) on studies with similar outcomes to evaluate the effectiveness of NPD. Because a comprehensive search was conducted for medical procedures in the current study, it is assumed that there is variation in medical procedures; thus, a separate meta-analysis was performed by medical procedure. For all analyses, a 2-sided P value < .05 was considered significant. Risk ratios were calculated with 95% confidence intervals (CIs) for dichotomous outcome analyses. Mean differences were reported for concomitant outcomes measured on the same scale, and standardized mean differences and associated 95% CIs were reported for those measured on different scales. We calculated statistical heterogeneity using the I² statistics and assigned heterogeneity using I² values (I² values of 0% to 40%: may not be important; 30% to 60%: may represent moderate heterogeneity; 50% to 90%: may represent substantial heterogeneity; and 75% to 100%: considerable heterogeneity). Furthermore, we visually interpreted heterogeneity using forest plots. If heterogeneity was present, we planned to analyze the possible factors associated with heterogeneity using subgroup and sensitivity analyses. We explored heterogeneity using the following between-study subgroup analyses: age, and type of intervention. Publication bias was assessed using funnel plots. For included studies with incomplete data necessary for meta-analysis, we reported the results separately (Supplement 4).

Two reviewers independently assessed the certainty of evidence for each meta-analytic comparison using the grading of recommendations, assessment, development, and evaluation (GRADE) approach. Discrepancies were resolved through a discussion.

Of 33 344 abstracts identified through the database search, 19 291 records were removed before screening. A total of 14 053 records were screened by title and abstract; 247 full-text articles were screened to determine eligibility for inclusion. Of these, 22 were included in the final review; 14 were used for the meta-analysis. Figure 1 shows the PRISMA flowchart of our analysis. A total of 224 studies did not meet the criteria for population, intervention, outcome, study design, language, and publication type and were excluded (Supplement 2).

The present review included 1968 children from 22 RCTs^11–32  that compared medical procedures with and without NPD. Table 1 summarizes the main characteristics of all included studies. We organized the final 22 studies based on the type of medical procedure (most commonly, 14 studies, venipuncture [n = 1415; 72%]).^11–24  The main methods used for NPD were audiovisual distraction (eg, animation using a tablet, television, or VR) and toys, eg, cards, balls, and video games. The ages of the included patients ranged from 1 to 18 years. In 2 studies, the possibility of conflict of interest was mentioned.^16,26  For all included references that lacked the information necessary for meta-analysis, the responsible authors were contacted but were not available.

Supplement 3 shows the detailed risk of bias. Most studies were judged as having a high overall risk of bias owing to a lack of blinding and insufficient information to determine the risk of bias in the selection of the reported result (for studies judged to have concerns in multiple domains, we decided on an overall judgment of high risk of bias).

Effect sizes for the procedure time of venipuncture were generated for 7 of 14 studies (Fig 2).^{12,14,16–18,21,24}  Six studies used audiovisual distraction such as VR and tablet. Using the random-effects model, no statistically significant difference was found in venipuncture procedure time (mean difference [MD]: −9.79; 95% CI: −22.38 to 2.81; I²: 33%; 7 RCTs; 731 children; low certainty). We did not conduct another planned subgroup analysis because of the limited number of trials and the fact that data were not reported separately for different age groups. Two studies could not be integrated because they did not provide information on the value of the mean, SD, and 95% confidence interval necessary for meta-analysis.^25,26  In addition, these 2 studies reported no significant difference among the groups (Supplement 4).

Eight studies were identified as relevant for this review (Table 2).

Wound care, imaging tests, and immunizations were included in 8 RCTs.^25–32 

Two studies showed a reduction in treatment time.^27,29  One study showed longer treatment times in the intervention group.³²  The other 5 studies showed no difference in procedure time between the NPD and control groups.^{25,26,28–30} 

Effect sizes for the success rate were generated for 7 studies.^{11,13–15,17,19,20}  Four studies used audiovisual distraction and 3 studies used toys (cards and video games). The results for this outcome showed no significant difference between patients with and without NPD (risk ratio: 0.98; 95% CI: 0.92 to 1.03; I2: 0%; 7 RCTs: 647 children; low certainty). We did not conduct a subgroup analysis owing to the limited number of trials for this outcome.

No study reported this outcome.

We were unable to assess the reporting bias using funnel plots because of the limited number of trials in the meta-analysis (n = 7).

The certainty of evidence was evaluated for procedure time and success rate. The overall certainty of evidence for the outcomes ranged from low to moderate. For first-time success rate, the evidence was downgraded by 1 for risk of bias. For procedure time, it was downgraded by the risk of bias and width of the 95% confidence interval (because it is wide on 1 side) although the number of cases was sufficient. A summary of findings and the GRADE evidence profile are presented in Table 3.

To the best of our knowledge, this is the first systematic review and meta-analysis that focused on the advantages of NPD for medical providers during pediatric medical procedures. In our review, we could not find clear benefits for medical providers, such as reduced medical procedure time or increased first-time success rates for venipuncture. Because of the small number of studies included, lack of a large number of cases, and low level of evidence for procedure time, further studies are warranted before conclusions can be reached on the benefits to medical providers.

The review included a variety of medical procedures, from venipuncture and echocardiography to burn treatment, which would be inappropriate to integrate in the same meta-analysis; a meta-analysis was not possible because of the small number of studies that included procedures other than venipuncture.

The procedure time and initial success rate of venipuncture were not improved by NPD. One factor that may have contributed to the lack of change in these outcomes was increased staffing to restrain patients in the control groups. In our review, we did not find any RCTs that reported the number of medical personnel needed during the procedure. A previous study reported that the use of VR during venipuncture reduced the number of personnel needed to restrain pediatric patients.³³  As to this study, various NPDs were used in the control group and were excluded from this review. Further studies are needed to validate the clinical significance of NPD during venipuncture, given that the number of personnel needed has not been evaluated, few studies and cases were included, and there was a low level of evidence.

Regarding medical procedures other than venipuncture, the small number of studies included in our review and the wide variety of medical procedures could not be integrated. However, it is well known that NPDs also reduce pain in these procedures,^5,6  and no disadvantages to the intervention group, such as longer procedure times, were found in this study. This suggests that NPD should continue to be used in these procedures.

The following limitations must be considered when interpreting the results of the present review and meta-analysis. First, some studies did not report the data required for a meta-analysis and thus, could not be included in this study. Second, age is a factor that should be considered in children. However, we could not examine age-related differences in this study because the data were not reported separately for different ages. Another limitation of the study is that the definition of treatment duration varied from study to study, resulting in different treatment times for the same venipuncture procedure, which were meta-integrated. Finally, we only included results from full-text English papers, which may have resulted in publication bias.

Despite these limitations, our study had several strengths. First, its comprehensive search strategy and rigorous methodology described using the PRISMA guidelines helped strengthen the study. Second, this study is the first to focus on the benefits of NPD to medical practitioners, which may encourage the use of such interventions during medical procedures. Finally, NPDs were defined as those that could be easily and quickly implemented, such as music and images, which highlighted the possibility that the results could be generalized.

This is the first systematic review and meta-analysis to evaluate the benefits of NPD to healthcare providers who provide NPDs to reduce pain and anxiety during medical procedures in pediatric patients. In our review, we did not find any benefits of NPD, such as procedure time, to the healthcare providers. Because it is well known that NPD relieves pain and stress and no disadvantage to healthcare providers was observed in the current study, its use during medical procedures is recommended. The small number of studies and patients included indicate that further research is needed to reach conclusions about the benefits of NPD to medical providers.

We thank Mr. Masahiko Watanabe, Ms. Chiemi Kataoka, and Ms. Yuko Serizawa for developing and executing the search strategy.