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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Instead of nitrous oxide, which is the standard procedure, virtual reality gaming is applied to reach pain reduction in minor surgery procedures
Standard procedure
Inselspital Bern
Bern, Switzerland
RECRUITINGVisual 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 0-10 (0: minimum value, no pain; 10: maximum value, strongest imaginable pain)
Time frame: 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 0-10 (0: minimum value, no pain; 10: maximum value, strongest imaginable pain)
Time frame: 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 0-10 (0: minimum value, no pain; 10: maximum value, strongest imaginable pain)
Time frame: 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 0-10 (0: minimum value, no pain; 10: maximum value, strongest imaginable pain)
Time frame: Two weeks after surgery
Change in objective pain reaction measured by heart frequencies
Elevation of the heart rate indicates pain
Time frame: 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
Time frame: Before (up to 3 minutes) and directly after the surgery (up to 3 minutes)
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Two weeks after surgery
Time limit of virtual reality gaming
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)
Time frame: During the surgery (estimated to be 3 to 25 minutes)
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