Clinical trial NCT05510141: Virtual Reality Games in Pediatric Surgery
Official title: A Randomized Controlled Trial Comparing Virtual Reality Games Versus Nitrous Oxide for Pain Reduction in Common Outpatient Procedures in Pediatric Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Analgesia
Surgical Procedure, Unspecified
Immersion
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Visual face scale of Bieri score directly after surgery
timeFrame: Directly after surgery (up to 20 minutes)
measure: Visual analogue scale (VAS) directly after surgery
timeFrame: Directly after surgery (up to 20 minutes)
measure: Visual face scale of Bieri score two weeks after surgery
timeFrame: Two weeks after surgery
measure: Visual analogue scale (VAS) two weeks after surgery
timeFrame: Two weeks after surgery
measure: Change in objective pain reaction measured by heart frequencies
timeFrame: During the procedure, estimated to be in average 15-20min
measure: Change in objective pain reaction measured by blood pressure
timeFrame: Before (up to 3 minutes) and directly after the surgery (up to 3 minutes)
Secondary outcomes:
measure: Fun directly after surgery
timeFrame: Directly after surgery (up to 20 minutes)
measure: Fun two weeks after surgery
timeFrame: Two weeks after surgery
measure: Patient satisfaction directly after surgery
timeFrame: Directly after surgery (up to 20 minutes)
measure: Patient satisfaction two weeks after surgery
timeFrame: Two weeks after surgery
measure: Time limit of virtual reality gaming
timeFrame: During the surgery (estimated to be 3 to 25 minutes)
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital Bern
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Cordula Scherer, Dr.med
role: PRINCIPAL_INVESTIGATOR
References: