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

Not Applicable

Recruiting

• Conditions: Acute Pain

• Registration Number: NCT05796596
• Lead Sponsor: University of Liege

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.

Study Timeline

• Study Start: 2023-02-01
• Status Verified: 2023-03
• Study First Submitted: 2023-03-06
• Study First Submitted QC: 2023-03-21
• Last Update Submitted: 2023-03-21
• Study First Posted: 2023-04-03
• Last Update Posted: 2023-04-03
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• speaking French regularly,
• requiring a skin prick test

Exclusion Criteria

• have an epilepsy disorder
• have blindness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.).
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).
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.
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).
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.
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.
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.

Trial Locations

Locations (1)

Clinique CHC MontLégia; 🇧🇪 Liège, Belgium