AbstractBackground Children often experience anxiety and pain during minor surgical procedures, prompting the search for effective pain management strategies beyond traditional pharmaceutical approaches. This study aims to evaluate the efficacy of virtual reality (VR) as a pain reduction method in pediatric outpatient surgical interventions compared to the standard use of nitrous oxide. The research questions explore pain reduction levels, patient preferences, enjoyment during VR use and the time limit of the VR application. Methods The study employs a randomized controlled trial design, utilizing VR technology and nitrous oxide in separate groups in 100 children at the age from 6 to 15 undergoing minor surgical procedures. Outcomes are monitored directly after the intervention and two weeks following the procedure. The primary outcome measure is the pain level, assessed using visual face and visual analog scales. Secondary outcomes are the fun and/or fear experienced during the intervention, the willingness to undergo the same procedure again (if necessary) and whether there is a time limit with the VR application compared to nitrous oxide. The study also considers adverse events and safety measures. Discussion The study aims to address a significant research gap in pediatric pain management strategies, as it is the first randomized controlled trial designed to compare pain levels using VR versus a control group with nitrous oxide analgosedation in children undergoing minor surgical procedures. Preliminary evidence suggests VR may offer a viable alternative to traditional pain management methods, as VR technology could be an effective distraction and pain management tool for pediatric patients undergoing outpatient surgical procedures. Trial registration ClinicalTrials.gov NCT05510141 Registered on August 22, 2022. Virtual Reality Games in Pediatric Surgery - Full Text View - ClinicalTrials.gov Primary Registry and Trial Identifying Number: ClinicalTrials.gov NCT05510141 Date of Registration in Primary Registry: August 22, 2022 Secondary Identifying Numbers: Unique Protocol ID: 2020-01446 Source(s) of Monetary or Material Support: University hospital Inselspital, Berne, Switzerland, Hospital foundation Batzebär, 2021, Stiftung Kinder Insel Bern, peer reviewed, 2023 Primary Sponsor: University Hospital Inselspital, Berne, Switzerland Contact for Public Queries: Dr.med. Cordula Scherer, Clinic for pediatric surgery Inselspital Bern, Bern University hospital, CH 3010 Bern, Switzerland, +41 31 632 92 38 cordula.scherer@insel.ch Contact for Scientific Queries: Dr.med. Cordula Scherer, Clinic for pediatric surgery Inselspital Bern, Bern University hospital, CH 3010 Bern, Switzerland, +41 31 632 92 38 cordula.scherer@insel.ch Public Title: Virtual Reality Games in Pediatric Surgery Scientific Title: A Randomized Controlled Trial Comparing Virtual Reality Games Versus Nitrous Oxide for Pain Reduction in Common Outpatient Procedures in Pediatric Surgery Countries of Recruitment: Switzerland Health Condition(s) or Problem(s) Studied: Outpatient Procedures in Pediatric Surgery Intervention(s): Experimental: Virtual Reality Gaming. Active Comparator: Nitrous Oxide Standard procedure Key Inclusion and Exclusion Criteria: Inclusion Criteria: Indication to undergo an elective minor surgical procedure, age 6 – 15 years old, written informed consent by parents and by patient if patient is 14 or 15 years old. Exclusion Criteria: Inability to understand the VR-program, Inability to fill in the questionnaire because of language deficiencies, Neurologic disorders, Respiratory tract infections, Intolerance of the VR headset or VR gaming procedure Study Type: interventional, randomized, no masking, parallel assignment, Primary purpose: treatment Date of First Enrollment: August 24, 2022 Target sample Size: 100 Recruitment Status: Recruiting Primary Outcomes: Pain scale to measure pain reduction during surgery measured 1) directly after surgery (up to 20 minutes) and 2) two weeks after surgery, measured with Visual face scale of Bieri for children at the age 6-9 and with Visual analogue scale (VAS) for children at the age 10-15; both scores result in a pain score from 0-10 (0: minimum value; 10: maximum value), to add to the measure of a potential pain reaction measure of 3) heartrate and 4) blood pressure before (up to 3 minutes) and directly after the surgery (up to 3 minutes) Key Secondary Outcomes: Fun 1) directly after surgery (up to 20 minutes) and 2) two weeks after surgery, measured by questionnaires with a Likert Scale from 1 to 6 (1= no fun, 6= maximum of fun); Patient satisfaction 1) directly after surgery (up to 20 minutes and 2) two weeks after surgery, measured by questionnaires if he/she woud undergo the procedures again with a Likert Scale from 1 to 6 (1= would absolutely not do it again, 6= would absolutely do it again)
Children often experience anxiety and pain during minor surgical procedures, prompting the search for effective pain management strategies beyond traditional pharmaceutical approaches. This study aims to evaluate the efficacy of virtual reality (VR) as a pain reduction method in pediatric outpatient surgical interventions compared to the standard use of nitrous oxide. The research questions explore pain reduction levels, patient preferences, enjoyment during VR use, and the time limit of the VR application. The study employs a randomized controlled trial design, utilizing VR technology and nitrous oxide in separate groups in 100 children at the age from 6 to 15 undergoing minor surgical procedures. Outcomes are monitored directly after the intervention and two weeks following the procedure. The primary outcome measure is the pain level, assessed using visual face and visual analog scales. Secondary outcomes are the fun and/or fear experienced during the intervention, the willingness to undergo the same procedure again (if necessary), and whether there is a time limit with the VR application compared to nitrous oxide. The study also considers adverse events and safety measures. The study aims to address a significant research gap in pediatric pain management strategies, as it is the first randomized controlled trial designed to compare pain levels using VR versus a control group with nitrous oxide analgosedation in children undergoing minor surgical procedures. Preliminary evidence suggests VR may offer a viable alternative to traditional pain management methods, as VR technology could be an effective distraction and pain management tool for pediatric patients undergoing outpatient surgical procedures. ClinicalTrials.gov NCT05510141. Registered on August 22, 2022. Virtual Reality Games in Pediatric Surgery—Full Text View—ClinicalTrials.gov. The principal investigator, Cordula Scherer act as the Sponsor, Clinic for pediatric surgery, Inselspital, Bern University Hospital, CH 3010 Bern, Switzerland.
