Virtual Reality Games in Pediatric Surgery

Study Overview
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Brief Summary
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Randomized controlled trial reporting the pain levels and pain control/reduction of children at the age of 6-15 undergoing surgical procedures by using 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.

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

Conditions
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Analgesia, Surgical Procedure, Unspecified, Immersion

Intervention / Treatment
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* Other: Virtual reality gaming
* Drug: Nitrous oxide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 1-10 (1: 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 1-10 (1: 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 1-10 (1: 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 1-10 (1: minimum value, no pain; 10: maximum value, strongest imaginable pain) | Two weeks after surgery | 
| 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) | 

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 |