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Virtual Reality Games in Pediatric Surgery

Primary Purpose

Analgesia, Surgical Procedure, Unspecified, Immersion

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Virtual reality gaming
Nitrous oxide
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia

Eligibility Criteria

6 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Inselspital BernRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual Reality Gaming

Nitrous Oxide

Arm Description

Standard procedure

Outcomes

Primary Outcome Measures

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 1-10 (1: minimum value, no pain; 10: maximum value, strongest imaginable pain)
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 1-10 (1: minimum value, no pain; 10: maximum value, strongest imaginable pain)
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 1-10 (1: minimum value, no pain; 10: maximum value, strongest imaginable pain)
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 1-10 (1: minimum value, no pain; 10: maximum value, strongest imaginable pain)
Change in objective pain reaction measured by heart frequencies
Elevation of the heart rate indicates pain
Change in objective pain reaction measured by blood pressure
Elevation of blood pressure indicates pain, we measure the difference between the two measures

Secondary Outcome Measures

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)
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)
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)
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)

Full Information

First Posted
August 16, 2022
Last Updated
July 3, 2023
Sponsor
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT05510141
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 24, 2022 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia, Surgical Procedure, Unspecified, Immersion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Gaming
Arm Type
Experimental
Arm Title
Nitrous Oxide
Arm Type
Active Comparator
Arm Description
Standard procedure
Intervention Type
Other
Intervention Name(s)
Virtual reality gaming
Intervention Description
Instead of nitrous oxide, which is the standard procedure, virtual reality gaming is applied to reach pain reduction in minor surgery procedures
Intervention Type
Drug
Intervention Name(s)
Nitrous oxide
Intervention Description
Standard procedure
Primary Outcome Measure Information:
Title
Visual face scale of Bieri score directly after surgery
Description
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)
Time Frame
Directly after surgery (up to 20 minutes)
Title
Visual analogue scale (VAS) directly after surgery
Description
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)
Time Frame
Directly after surgery (up to 20 minutes)
Title
Visual face scale of Bieri score two weeks after surgery
Description
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)
Time Frame
Two weeks after surgery
Title
Visual analogue scale (VAS) two weeks after surgery
Description
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)
Time Frame
Two weeks after surgery
Title
Change in objective pain reaction measured by heart frequencies
Description
Elevation of the heart rate indicates pain
Time Frame
During the procedure, estimated to be in average 15-20min
Title
Change in objective pain reaction measured by blood pressure
Description
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)
Secondary Outcome Measure Information:
Title
Fun directly after surgery
Description
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)
Title
Fun two weeks after surgery
Description
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
Title
Patient satisfaction directly after surgery
Description
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)
Title
Patient satisfaction two weeks after surgery
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cordula Scherrer
Phone
+41 76 747 66 79
Email
cordula.scherrer@insel.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cordula Scherrer, Dr.med
Organizational Affiliation
Insel Gruppe AG, University Hospital Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inselspital Bern
City
Bern
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cordula Scherrer, Dr.med

12. IPD Sharing Statement

Plan to Share IPD
No

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Virtual Reality Games in Pediatric Surgery

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