Analgesia, Immersion, Surgical Procedure, Unspecified
Conditions
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.
Interventions
Instead of nitrous oxide, which is the standard procedure, virtual reality gaming is applied to reach pain reduction in minor surgery procedures
DRUGNitrous oxide
Standard procedure
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 15 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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) |
| 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) |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
Countries
Switzerland
Contacts
Primary ContactCordula Scherer
Outcome results
None listed