Virtual Reality Games in Pediatric Surgery

Not Applicable

Recruiting

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Virtual Reality Gaming	Virtual reality gaming	-
Nitrous Oxide	Nitrous oxide	Standard procedure

Primary Outcome Measures

Name	Time	Method
Visual face scale of Bieri score two weeks after surgery	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)
Visual analogue scale (VAS) two weeks after surgery	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)
Change in objective pain reaction measured by heart frequencies	During the procedure, estimated to be in average 15-20min	Elevation of the heart rate indicates pain
Visual face scale of Bieri score directly after surgery	Directly after surgery (up to 20 minutes)	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)
Change in objective pain reaction measured by blood pressure	Before (up to 3 minutes) and directly after the surgery (up to 3 minutes)	Elevation of blood pressure indicates pain, we measure the difference between the two measures
Visual analogue scale (VAS) directly after surgery	Directly after surgery (up to 20 minutes)	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)

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction directly after surgery	Directly after surgery (up to 20 minutes)	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)
Fun two weeks after surgery	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)
Time limit of virtual reality gaming	During the surgery (estimated to be 3 to 25 minutes)	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)
Fun directly after surgery	Directly after surgery (up to 20 minutes)	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)
Patient satisfaction two weeks after surgery	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)