A Randomized Controlled Trial Comparing Virtual Reality Games Versus Nitrous Oxide for Pain Reduction in Common Outpatient Procedures in Pediatric Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Virtual reality gaming
- Conditions
- Analgesia
- Sponsor
- Insel Gruppe AG, University Hospital Bern
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Visual face scale of Bieri score two weeks after surgery
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Cordula Scherer
Dr.med
Insel Gruppe AG, University Hospital Bern
Eligibility Criteria
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
Arms & Interventions
Virtual Reality Gaming
Intervention: Virtual reality gaming
Nitrous Oxide
Standard procedure
Intervention: Nitrous oxide
Outcomes
Primary Outcomes
Visual face scale of Bieri score two weeks after surgery
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Patient satisfaction directly after surgery(Directly after surgery (up to 20 minutes))
- Fun two weeks after surgery(Two weeks after surgery)
- Time limit of virtual reality gaming(During the surgery (estimated to be 3 to 25 minutes))
- Fun directly after surgery(Directly after surgery (up to 20 minutes))
- Patient satisfaction two weeks after surgery(Two weeks after surgery)