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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
150
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.
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.
Clinique CHC MontLégia
Liège, Belgium
RECRUITINGChild'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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.).
Time frame: T1 (before the skin prick testing for RV group only), T2 (right after the skin prick testing for RV group only).
Child satisfaction questionnaire
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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).
Time frame: 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).
Time frame: T2 (right after the skin prick testing for RV and Book groups only).