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

Sponsor
University of Liege (Other)
Overall Status
Recruiting
CT.gov ID
NCT05796596
Collaborator
(none)
150
1
3
19
7.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Experimental: Virtual Reality (VR) distraction
  • Behavioral: Active Comparator: Distraction by the book
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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)
Primary Purpose:
Supportive Care
Official Title:
Effectiveness of a Virtual Reality Game for Pediatric Pain and Anxiety Management During Skin Prick Testing
Actual Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Virtual Reality (VR) distraction

Distraction intervention using a virtual environment

Behavioral: Experimental: Virtual Reality (VR) distraction
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.

Active Comparator: Distraction by the book

Distraction intervention using a book visualization

Behavioral: Active Comparator: Distraction by the book
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.

No Intervention: Usual care

Control group receiving usual care and no distraction.

Outcome Measures

Primary Outcome Measures

  1. Child's perceived pain [T2 (right after the skin prick testing).]

    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.

  2. Child's behavioral pain assessment [During the skin prick testing.]

    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.

  3. Change in child's state anxiety [T1 (before the skin prick testing), T2 (right after the skin prick testing).]

    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.

  4. Change in parent's state anxiety [T1 (before the skin prick testing), T2 (right after the skin prick testing).]

    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.

  5. Change in simulator sickness [T1 (before the skin prick testing for RV group only), T2 (right after the skin prick testing for RV group only).]

    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.).

  6. Child satisfaction questionnaire [T2 (right after the skin prick testing for RV and Book groups only).]

    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).

  7. Parent satisfaction questionnaire [T2 (right after the skin prick testing for RV and Book groups only).]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 7 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • speaking French regularly,

  • requiring a skin prick test

Exclusion Criteria:
  • have an epilepsy disorder

  • have blindness

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinique CHC MontLégia Liège Belgium 4000

Sponsors and Collaborators

  • University of Liege

Investigators

  • Principal Investigator: Céline Stassart, PhD, University of Liege

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Liege
ClinicalTrials.gov Identifier:
NCT05796596
Other Study ID Numbers:
  • RV-child-pain
First Posted:
Apr 3, 2023
Last Update Posted:
Apr 3, 2023
Last Verified:
Mar 1, 2023
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
Keywords provided by University of Liege
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 3, 2023