Virtual Reality Games in Pediatric Surgery
Study Details
Study Description
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 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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Virtual Reality Gaming
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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
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Active Comparator: Nitrous Oxide Standard procedure |
Drug: Nitrous oxide
Standard procedure
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Outcome Measures
Primary Outcome Measures
- 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 1-10 (1: minimum value, no pain; 10: maximum value, strongest imaginable pain)
- 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 1-10 (1: minimum value, no pain; 10: maximum value, strongest imaginable pain)
- 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 1-10 (1: 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 1-10 (1: 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
- 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
Secondary Outcome Measures
- 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)
- 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)
- 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)
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Indication to undergo an elective minor surgical procedure (removal of percutaneous osteosynthesis or pin material or dressing change)
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Written informed consent by parents
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Written informed consent by patient if patient is 14 or 15 years old
Exclusion Criteria:
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Inability to understand the VR-program
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Inability to fill in the questionnaire because of language deficiencies
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Neurologic disorders
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Respiratory tract infections
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Intolerance of the VR headset or VR gaming procedure
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Inselspital Bern | Bern | Switzerland |
Sponsors and Collaborators
- University Hospital Inselspital, Berne
Investigators
- Principal Investigator: Cordula Scherrer, Dr.med, University Hospital Inselspital, Berne
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020-01446