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

University of Liege

Status: Enrolling

Conditions: Acute Pain

Treatments: Behavioral: Active Comparator: Distraction by the book; Behavioral: Experimental: Virtual Reality (VR) distraction

Study type: Interventional

Funder types: Other

Identifiers

NCT05796596

RV-child-pain

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 4 to 7 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• speaking French regularly,
• requiring a skin prick test

Exclusion criteria

• have an epilepsy disorder
• have blindness

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Virtual Reality (VR) distraction

Experimental group

Description:

Distraction intervention using a virtual environment

Treatment:

Behavioral: Experimental: Virtual Reality (VR) distraction

Distraction by the book

Active Comparator group

Description:

Distraction intervention using a book visualization

Treatment:

Behavioral: Active Comparator: Distraction by the book

Usual care

No Intervention group

Description:

Control group receiving usual care and no distraction.