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

NCT ID: NCT05796596

Last Updated: 2023-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-09-01

Brief Summary

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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

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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.

Conditions

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Acute Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Virtual Reality (VR) distraction

Distraction intervention using a virtual environment

Group Type EXPERIMENTAL

Experimental: Virtual Reality (VR) distraction

Intervention Type 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.

Distraction by the book

Distraction intervention using a book visualization

Group Type ACTIVE_COMPARATOR

Active Comparator: Distraction by the book

Intervention Type 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.

Usual care

Control group receiving usual care and no distraction.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* speaking French regularly,
* requiring a skin prick test

Exclusion Criteria

* have an epilepsy disorder
* have blindness
Minimum Eligible Age

4 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Liege

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Céline Stassart, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Liege

Locations

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Clinique CHC MontLégia

Liège, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Céline Stassart, PhD

Role: CONTACT

+32495906750

Karin Giebels, Doctor

Role: CONTACT

+324 355 50 20

Facility Contacts

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Karin Giebels, Doctor

Role: primary

+3204 355 50 20

Céline Stassart, PhD

Role: backup

+320495906750

Other Identifiers

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RV-child-pain

Identifier Type: -

Identifier Source: org_study_id

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