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Effectiveness of a Virtual Reality Game for Pediatric Pain and Anxiety Management During Skin Prick Testing

Primary Purpose

Acute Pain

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Experimental: Virtual Reality (VR) distraction
Active Comparator: Distraction by the book
Sponsored by
University of Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Pain focused on measuring Children, Anxiety, Pain, Skin Prick Testing

Eligibility Criteria

4 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: speaking French regularly, requiring a skin prick test Exclusion Criteria: have an epilepsy disorder have blindness

Sites / Locations

  • Clinique CHC MontLégiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Virtual Reality (VR) distraction

Distraction by the book

Usual care

Arm Description

Distraction intervention using a virtual environment

Distraction intervention using a book visualization

Control group receiving usual care and no distraction.

Outcomes

Primary Outcome Measures

Child's perceived pain
Child's perceived pain during prick test. Measured with Face Pain Scale - Revised (FPS-R) that is a self-report measure of pain intensity developed for children. Scores range from 0 (not bad at all) to 10 (very bad). The higher the score, the greater the pain.
Child's behavioral pain assessment
Child's behavioral pain assessment during skin prick testing. Measured with Face Legs Activity Cry Consolability (FLACC) that is behavioral pain assessment scale used for nonverbal or preverbal patients who are unable to self-report their level of pain. Scores range from 0 to 10. The higher the score, the greater the pain.
Change in child's state anxiety
Child skin prick testing anxiety. Measured with Glasses Fear Scale (GFQ; heteroevaluation and completed by the parent). Scores range from 0 (no fear) to 5 (intense fear). The higher the score, the greater the fear.
Change in parent's state anxiety
Parent skin prick testing anxiety. Measured with Glasses Fear Scale (GFQ). Scores range from 0 (no fear) to 5 (intense fear). The higher the score, the greater the fear.
Change in simulator sickness
Measured with Simulator Sickness Questionnaire (SSQ) that is an instrument which is used to measure the extent to which children feel simulator sickness due to their immersion in VR (e.g., nausea, eye fatigue, dizziness, etc.).
Child satisfaction questionnaire
Satisfaction questionnaire is a visual analogue scale to measure the degree of child satisfaction related to the distraction used during the skin prick testing. Scores range from 0 (very dissatisfied) to 100 (very satisfied).
Parent satisfaction questionnaire
Satisfaction questionnaire is a visual analogue scale to measure the degree of parent satisfaction related to the distraction used during the skin prick testing. Scores range from 0 (very dissatisfied) to 100 (very satisfied).

Secondary Outcome Measures

Full Information

First Posted
March 6, 2023
Last Updated
March 21, 2023
Sponsor
University of Liege
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1. Study Identification

Unique Protocol Identification Number
NCT05796596
Brief Title
Effectiveness of a Virtual Reality Game for Pediatric Pain and Anxiety Management During Skin Prick Testing
Official Title
Effectiveness of a Virtual Reality Game for Pediatric Pain and Anxiety Management During Skin Prick Testing
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Liege

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
This study investigated the effectiveness of virtual reality (VR) distraction, compared to book distraction and no distraction, in reducing pain and anxiety during a medical procedure in a pediatric population: the skin prick test. Although this test has many advantages and is considered to be minimally invasive, it causes anxiety and painful discomfort in children. This study concerns children aged 4 to 7 years consulting for an allergic test. Outcome measures include pain score, level of anxiety, VR measures, and satisfaction questionnaires.
Detailed Description
The use of skin prick tests is considered a gold standard in the evaluation of allergic reactions. These tests involve depositing a drop or small amount of the allergen on the skin and pricking the skin to let the allergen penetrate the epidermis. Although this test has many advantages and is considered to be minimally invasive, it causes anxiety and painful discomfort for children. Managing pain and anxiety during skin prick testing is essential to prevent long-term adverse effects, especially in the case of future needle-stick interventions. To our knowledge, the studies investigating distraction methods effect on reducing anxiety and pain during skin prick tests in childrenremain limited. No study has yet investigated the value of VR as a distraction tool in this field. We postulate a greater decrease in child pain and child and parent anxiety in the RV and book conditions compared to the control group. We also postulate a larger effect for the RV group compared to the book group. In the VR group, we postulate the absence of an increase in post-immersion cybersickness symptoms. In last, we postulated a good satisfaction to distractions proposed, with a best score for RV distraction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
Keywords
Children, Anxiety, Pain, Skin Prick Testing

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Children were randomly assigned to one of three conditions: VR distraction group, book distraction control group, and no distraction group. Random assignments were generated with a random numbers table before recruitment by the researcher.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality (VR) distraction
Arm Type
Experimental
Arm Description
Distraction intervention using a virtual environment
Arm Title
Distraction by the book
Arm Type
Active Comparator
Arm Description
Distraction intervention using a book visualization
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Control group receiving usual care and no distraction.
Intervention Type
Behavioral
Intervention Name(s)
Experimental: Virtual Reality (VR) distraction
Intervention Description
Children in the VR distraction group will begin interacting with the virtual environment (VE) 2 minutes prior to the skin prick test and will continue playing throughout. The VR environment is a game in which the child draw a 360 degree image.
Intervention Type
Behavioral
Intervention Name(s)
Active Comparator: Distraction by the book
Intervention Description
In the book distraction group, the child will be invited to find and count animals in various landscapes. The book will be given 2 minutes prior to the skin prick test and continued reading throughout.
Primary Outcome Measure Information:
Title
Child's perceived pain
Description
Child's perceived pain during prick test. Measured with Face Pain Scale - Revised (FPS-R) that is a self-report measure of pain intensity developed for children. Scores range from 0 (not bad at all) to 10 (very bad). The higher the score, the greater the pain.
Time Frame
T2 (right after the skin prick testing).
Title
Child's behavioral pain assessment
Description
Child's behavioral pain assessment during skin prick testing. Measured with Face Legs Activity Cry Consolability (FLACC) that is behavioral pain assessment scale used for nonverbal or preverbal patients who are unable to self-report their level of pain. Scores range from 0 to 10. The higher the score, the greater the pain.
Time Frame
During the skin prick testing.
Title
Change in child's state anxiety
Description
Child skin prick testing anxiety. Measured with Glasses Fear Scale (GFQ; heteroevaluation and completed by the parent). Scores range from 0 (no fear) to 5 (intense fear). The higher the score, the greater the fear.
Time Frame
T1 (before the skin prick testing), T2 (right after the skin prick testing).
Title
Change in parent's state anxiety
Description
Parent skin prick testing anxiety. Measured with Glasses Fear Scale (GFQ). Scores range from 0 (no fear) to 5 (intense fear). The higher the score, the greater the fear.
Time Frame
T1 (before the skin prick testing), T2 (right after the skin prick testing).
Title
Change in simulator sickness
Description
Measured with Simulator Sickness Questionnaire (SSQ) that is an instrument which is used to measure the extent to which children feel simulator sickness due to their immersion in VR (e.g., nausea, eye fatigue, dizziness, etc.).
Time Frame
T1 (before the skin prick testing for RV group only), T2 (right after the skin prick testing for RV group only).
Title
Child satisfaction questionnaire
Description
Satisfaction questionnaire is a visual analogue scale to measure the degree of child satisfaction related to the distraction used during the skin prick testing. Scores range from 0 (very dissatisfied) to 100 (very satisfied).
Time Frame
T2 (right after the skin prick testing for RV and Book groups only).
Title
Parent satisfaction questionnaire
Description
Satisfaction questionnaire is a visual analogue scale to measure the degree of parent satisfaction related to the distraction used during the skin prick testing. Scores range from 0 (very dissatisfied) to 100 (very satisfied).
Time Frame
T2 (right after the skin prick testing for RV and Book groups only).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: speaking French regularly, requiring a skin prick test Exclusion Criteria: have an epilepsy disorder have blindness
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Céline Stassart, PhD
Phone
+32495906750
Email
cstassart@uliege.be
First Name & Middle Initial & Last Name or Official Title & Degree
Karin Giebels, Doctor
Phone
+324 355 50 20
Email
karingiebels@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Céline Stassart, PhD
Organizational Affiliation
University of Liege
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique CHC MontLégia
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karin Giebels, Doctor
Phone
+3204 355 50 20
Email
karingiebels@hotmail.com
First Name & Middle Initial & Last Name & Degree
Céline Stassart, PhD
Phone
+320495906750
Email
cstassart@uliege.be
First Name & Middle Initial & Last Name & Degree
Céline Stassart, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of a Virtual Reality Game for Pediatric Pain and Anxiety Management During Skin Prick Testing

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