Virtual Reality Games in Pediatric Surgery

A Randomized Controlled Trial Comparing Virtual Reality Games Versus Nitrous Oxide for Pain Reduction in Common Outpatient Procedures in Pediatric Surgery

Randomized controlled trial reporting the pain levels and pain control/reduction of children at the age of 6-15 undergoing surgical procedures by using virtual reality gaming (VR) compared to nitrous oxide. Therefore, 50 patients in each treatment group are recruited, resulting in 100 children altogether. The pain levels and pain control/reduction is measured by the standard anesthesia protocol normally used when nitrous oxide is applied and questionnaires that are administered to the patients at baseline and two weeks after surgery including both the primary and secondary outcome.

Study Overview

• Status: Recruiting
• Conditions: Analgesia; Surgical Procedure, Unspecified; Immersion
• Intervention / Treatment: Other: Virtual reality gaming; Drug: Nitrous oxide

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cordula Scherer; Phone Number: +41 31 632 92 38; Email: cordula.scherer@insel.ch

Study Locations

• Switzerland
  • Bern, Switzerland
    • Recruiting
    • Inselspital Bern
    • Contact: Cordula Scherer, Dr.med

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 15 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Indication to undergo an elective minor surgical procedure (removal of percutaneous osteosynthesis or pin material or dressing change)
• Written informed consent by parents
• Written informed consent 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Gaming	Other: Virtual reality gaming; Instead of nitrous oxide, which is the standard procedure, virtual reality gaming is applied to reach pain reduction in minor surgery procedures
Active Comparator: Nitrous Oxide; Standard procedure	Drug: Nitrous oxide; Standard procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in objective pain reaction measured by heart frequencies	Elevation of the heart rate indicates pain	During the procedure, estimated to be in average 15-20min
Change in objective pain reaction measured by blood pressure	Elevation of blood pressure indicates pain, we measure the difference between the two measures	Before (up to 3 minutes) and directly after the surgery (up to 3 minutes)
Visual face scale of Bieri score directly after surgery	Pain scale to measure pain reduction for children at the age 6-9, the score results in a pain score from 0-10 (0: minimum value, no pain; 10: maximum value, strongest imaginable pain)	Directly after surgery (up to 20 minutes)
Visual analogue scale (VAS) directly after surgery	Pain scale to measure pain reduction for children at the age 11-15, the score results in a pain score from 0-10 (0: minimum value, no pain; 10: maximum value, strongest imaginable pain)	Directly after surgery (up to 20 minutes)
Visual face scale of Bieri score two weeks after surgery	Pain scale to measure pain reduction for children at the age 6-9, the score results in a pain score from 0-10 (0: minimum value, no pain; 10: maximum value, strongest imaginable pain)	Two weeks after surgery
Visual analogue scale (VAS) two weeks after surgery	Pain scale to measure pain reduction for children at the age 11-15, the score results in a pain score from 0-10 (0: minimum value, no pain; 10: maximum value, strongest imaginable pain)	Two weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fun directly after surgery	Did the patient have fun during the procedures, measured by questionnaires with a Likert Scale from 1 to 6 (1= no fun, 6= maximum of fun)	Directly after surgery (up to 20 minutes)
Fun two weeks after surgery	Did the patient have fun during the procedures, measured by questionnaires with a Likert Scale from 1 to 6 (1= no fun, 6= maximum of fun)	Two weeks after surgery
Patient satisfaction directly after surgery	The patient is asked in the 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)	Directly after surgery (up to 20 minutes)
Patient satisfaction two weeks after surgery	The patient is asked in the 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)	Two weeks after surgery
Time limit of virtual reality gaming	The time is measured while nitrous oxide or virtual reality gaming is administered. The investigators evaluate if there is a time limit for virtual reality gaming, where they have to stop the intervention (comparable to the time limit of nitrous oxide application of 20 min)	During the surgery (estimated to be 3 to 25 minutes)

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Investigators: Principal Investigator: Cordula Scherer, Dr.med, Insel Gruppe AG, University Hospital Bern

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2022
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: August 16, 2022
• First Submitted That Met QC Criteria: August 18, 2022
• First Posted (Actual): August 22, 2022

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Anesthetics, Inhalation; Nitrous Oxide
• Other Study ID Numbers: 2020-01446

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The final trial data set and statistical code will be made available from the corresponding author from three months following the final enrollment of patients within reasonable request, and will be published as mentioned in the ethical approvement. We plan to publish the study protocol in a peer-reviewed journal before end of enrolling.
• IPD Sharing Time Frame: Study Protocol: before end of enrolling Data Set and Statistical code: from three months following the final enrollment
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No