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

Acute Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05796596
• Other study ID #: RV-child-pain
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: March 2023
• Source: University of Liege
• Contact: Céline Stassart, PhD
• Phone: +32495906750
• Email: cstassart[@]uliege.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 7 Years

Eligibility

Inclusion Criteria:

• speaking French regularly,

• requiring a skin prick test

Exclusion Criteria:

• have an epilepsy disorder

• have blindness

Related Conditions & MeSH terms

• Acute Pain

Intervention

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
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.

Locations

Country	Name	City	State
Belgium	Clinique CHC MontLégia	Liège

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	T2 (right after the skin prick testing).
Primary	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.	During the skin prick testing.
Primary	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.	T1 (before the skin prick testing), T2 (right after the skin prick testing).
Primary	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.	T1 (before the skin prick testing), T2 (right after the skin prick testing).
Primary	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.).	T1 (before the skin prick testing for RV group only), T2 (right after the skin prick testing for RV group only).
Primary	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).	T2 (right after the skin prick testing for RV and Book groups only).
Primary	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).	T2 (right after the skin prick testing for RV and Book groups only).