Virtual Reality Games in Pediatric Surgery

Sponsor
University Hospital Inselspital, Berne (Other)
Overall Status
Recruiting
CT.gov ID
NCT05510141
Collaborator
(none)
100
1
2
14.3
7

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
  • Other: Virtual reality gaming
  • Drug: Nitrous oxide
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Controlled Trial Comparing Virtual Reality Games Versus Nitrous Oxide for Pain Reduction in Common Outpatient Procedures in Pediatric Surgery
Anticipated Study Start Date :
Aug 24, 2022
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Virtual Reality Gaming

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

Active Comparator: Nitrous Oxide

Standard procedure

Drug: Nitrous oxide
Standard procedure

Outcome Measures

Primary Outcome Measures

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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

  6. 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

  1. 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)

  2. 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)

  3. 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)

  4. 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

Ages Eligible for Study:
6 Years to 15 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
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.
Responsible Party:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT05510141
Other Study ID Numbers:
  • 2020-01446
First Posted:
Aug 22, 2022
Last Update Posted:
Aug 22, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 22, 2022