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

NCT05796596 | Unknown

• 1 other identifier: RV-child-pain
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pain

Keywords

Children; Anxiety; Pain; Skin Prick Testing

Outcome Measures

Primary Outcomes (7)

• 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).

• 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.

• 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).

• 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).

• 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).

• 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).

• 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).

Study Arms (3)

Virtual Reality (VR) distraction

EXPERIMENTAL

Distraction intervention using a virtual environment

Behavioral: Experimental: Virtual Reality (VR) distraction

Distraction by the book

ACTIVE COMPARATOR

Distraction intervention using a book visualization

Behavioral: Active Comparator: Distraction by the book

Usual care

NO INTERVENTION

Control group receiving usual care and no distraction.

Interventions

Experimental: Virtual Reality (VR) distraction BEHAVIORAL

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.

Virtual Reality (VR) distraction

Active Comparator: Distraction by the book BEHAVIORAL

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.

Distraction by the book

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• speaking French regularly,
• requiring a skin prick test

You may not qualify if:

• have an epilepsy disorder
• have blindness

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

Clinique CHC MontLégia

Liège, 4000, Belgium

RECRUITING

MeSH Terms

Conditions

Acute Pain; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Céline Stassart, PhD

  University of Liege

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Céline Stassart, PhD

CONTACT

+32495906750; cstassart@uliege.be

Karin Giebels, Doctor

CONTACT

+324 355 50 20; karingiebels@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: April 3, 2023
• Study Start: February 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: April 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)