This randomized controlled trial compared three distraction techniques-animated cartoons, DistrACTION® Cards, and interactive video games-with standard care for reducing procedural pain and anxiety in children aged 6-10 years undergoing allergy skin prick testing. A total of 161 children were randomly assigned to four groups. Pain was rated by the child, a parent, and the researcher with the Wong-Baker FACES Pain Rating Scale during and after the procedure, and anxiety was rated by the parent and the researcher with the Children's Fear Scale before, during, and after the procedure.
This single-center, four-arm, parallel-group randomized controlled trial was conducted in the pediatric allergy outpatient clinic of a training and research hospital in Istanbul, Turkey, between November 2019 and January 2020. Children aged 6-10 years referred for allergy skin prick testing were randomly allocated by computer-generated assignment to a cartoon group (n = 40), a DistrACTION® Cards group (n = 40), a video game group (n = 40), or a standard-care control group (n = 41). All tests were performed by the same pediatric nurse under identical conditions. Between-group differences were tested with one-way ANOVA and change over time with two-way repeated-measures ANOVA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
161
Children watched a self-selected, age-appropriate animated cartoon on a tablet computer during the skin prick test.
Children viewed DistrACTION® Cards and answered goal-directed visual-search questions asked by the researcher during the skin prick test.
Children played a self-selected interactive video game on a tablet with the non-tested arm during the skin prick test.
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Istanbul, Turkey (Türkiye)
Child-reported procedural pain
Pain self-reported by the child on the Wong-Baker FACES Pain Rating Scale (0 = no pain to 10 = worst possible pain; higher scores indicate more pain).
Time frame: During the skin prick test, a procedure lasting approximately 3 minutes
Child-reported pain after the procedure
Pain self-reported by the child on the Wong-Baker FACES Pain Rating Scale (0 = no pain to 10 = worst possible pain; higher scores indicate more pain).
Time frame: Immediately after the skin prick test, up to 15 minutes after the procedure
Parent-reported pain
Pain reported by the parent on the Wong-Baker FACES Pain Rating Scale (0 = no pain to 10 = worst possible pain; higher scores indicate more pain).
Time frame: During the skin prick test (approximately 3 minutes) and immediately after the procedure (up to 15 minutes)
Researcher-reported pain
Pain reported by the researcher on the Wong-Baker FACES Pain Rating Scale (0 = no pain to 10 = worst possible pain; higher scores indicate more pain).
Time frame: During the skin prick test (approximately 3 minutes) and immediately after the procedure (up to 15 minutes)
Parent-reported anxiety
Anxiety reported by the parent using the Children's Fear Scale (0 = no anxiety to 4 = severe anxiety; higher scores indicate higher anxiety).
Time frame: Approximately 10 minutes before the skin prick test, during the test (approximately 3 minutes), and immediately after the procedure (up to 15 minutes)
Researcher-reported anxiety
Anxiety reported by the researcher using the Children's Fear Scale (0 = no anxiety to 4 = severe anxiety; higher scores indicate higher anxiety).
Time frame: Approximately 10 minutes before the skin prick test, during the test (approximately 3 minutes), and immediately after the procedure (up to 15 minutes)
Interrater agreement
Intraclass correlation coefficient between child, parent, and researcher ratings.
Time frame: During the skin prick test (approximately 3 minutes) and immediately after the procedure (up to 15 minutes)
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