Clinical trial NCT05796596: Effectiveness of a Virtual Reality Game for Pediatric Pain and Anxiety Management During Skin Prick Testing
Official title: Effectiveness of a Virtual Reality Game for Pediatric Pain and Anxiety Management During Skin Prick Testing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Pain
Keywords: Children
Anxiety
Pain
Skin Prick Testing
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 150
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* speaking French regularly,
* requiring a skin prick test

Exclusion Criteria:

* have an epilepsy disorder
* have blindness

Primary outcomes:
measure: Child's perceived pain
timeFrame: T2 (right after the skin prick testing).
measure: Child's behavioral pain assessment
timeFrame: During the skin prick testing.
measure: Change in child's state anxiety
timeFrame: T1 (before the skin prick testing), T2 (right after the skin prick testing).
measure: Change in parent's state anxiety
timeFrame: T1 (before the skin prick testing), T2 (right after the skin prick testing).
measure: Change in simulator sickness
timeFrame: T1 (before the skin prick testing for RV group only), T2 (right after the skin prick testing for RV group only).
measure: Child satisfaction questionnaire
timeFrame: T2 (right after the skin prick testing for RV and Book groups only).
measure: Parent satisfaction questionnaire
timeFrame: T2 (right after the skin prick testing for RV and Book groups only).
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: Clinique CHC MontLégia
Study officials:
affiliation: University of Liege
name: Céline Stassart, PhD
role: PRINCIPAL_INVESTIGATOR
References: