Procedural Anxiety, Procedural Pain
Conditions
Keywords
child, distraction, skin prick test, video games, cartoons, distraction cards
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALAnimated cartoon distraction
Children watched a self-selected, age-appropriate animated cartoon on a tablet computer during the skin prick test.
BEHAVIORALDistraction card intervention
Children viewed DistrACTION® Cards and answered goal-directed visual-search questions asked by the researcher during the skin prick test.
BEHAVIORALInteractive video game distraction
Children played a self-selected interactive video game on a tablet with the non-tested arm during the skin prick test.
Sponsors
Istanbul University
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
* Aged 6-10 years * Referred for allergy skin prick testing * Consent of both child and parent * No analgesic use in the previous six hours * Able to understand the Wong-Baker FACES Pain Rating Scale and answer the card questions
Exclusion criteria
* Neurodevelopmental conditions (diagnosis of autism or intellectual disability) * Chronic mental, cognitive, or visual problems * Cognitive, visual, or hearing impairment preventing scale use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child-reported procedural pain | During the skin prick test, a procedure lasting approximately 3 minutes | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Child-reported pain after the procedure | Immediately after the skin prick test, up to 15 minutes 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). |
| Parent-reported pain | During the skin prick test (approximately 3 minutes) and immediately after the procedure (up to 15 minutes) | 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). |
| Researcher-reported pain | During the skin prick test (approximately 3 minutes) and immediately after the procedure (up to 15 minutes) | 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). |
| Parent-reported anxiety | Approximately 10 minutes before the skin prick test, during the test (approximately 3 minutes), and immediately after the procedure (up to 15 minutes) | Anxiety reported by the parent using the Children's Fear Scale (0 = no anxiety to 4 = severe anxiety; higher scores indicate higher anxiety). |
| Researcher-reported anxiety | Approximately 10 minutes before the skin prick test, during the test (approximately 3 minutes), and immediately after the procedure (up to 15 minutes) | Anxiety reported by the researcher using the Children's Fear Scale (0 = no anxiety to 4 = severe anxiety; higher scores indicate higher anxiety). |
| Interrater agreement | During the skin prick test (approximately 3 minutes) and immediately after the procedure (up to 15 minutes) | Intraclass correlation coefficient between child, parent, and researcher ratings. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORLeyla Erdim
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Outcome results
None listed