Virtual Reality Games in Pediatric Surgery

Analgesia Clinical Trial

Official title:

A Randomized Controlled Trial Comparing Virtual Reality Games Versus Nitrous Oxide for Pain Reduction in Common Outpatient Procedures in Pediatric Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05510141
• Other study ID #: 2020-01446
• Status: Recruiting
• Phase: N/A
• Start date: August 24, 2022
• Est. completion date: October 1, 2024

Study information

• Verified date: April 2024
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: Cordula Scherer
• Phone: +41 31 632 92 38
• Email: cordula.scherer[@]insel.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Immersion
• Surgical Procedure, Unspecified

Intervention

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

Drug:
• Nitrous oxide
Standard procedure

Locations

Country	Name	City	State
Switzerland	Inselspital Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual 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)	Directly after surgery (up to 20 minutes)
Primary	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)	Directly after surgery (up to 20 minutes)
Primary	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)	Two weeks after surgery
Primary	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)	Two weeks after surgery
Primary	Change in objective pain reaction measured by heart frequencies	Elevation of the heart rate indicates pain	During the procedure, estimated to be in average 15-20min
Primary	Change in objective pain reaction measured by blood pressure	Elevation of blood pressure indicates pain, we measure the difference between the two measures	Before (up to 3 minutes) and directly after the surgery (up to 3 minutes)
Secondary	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)	Directly after surgery (up to 20 minutes)
Secondary	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)	Two weeks after surgery
Secondary	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)	Directly after surgery (up to 20 minutes)
Secondary	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)	Two weeks after surgery
Secondary	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)	During the surgery (estimated to be 3 to 25 minutes)