- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07796087
Three Distraction Techniques for Pain and Anxiety in Children During Allergy Skin Prick Testing
August 26, 2026 updated by: Leyla Erdim, Istanbul University
The Effect of Three Different Distraction Techniques on Anxiety and Pain Levels in Children During Allergy Skin Prick Testing: A Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
161
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Istanbul, Turkey (Türkiye)
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cartoon group (CG)
Children watched a self-selected, age-appropriate animated cartoon on a tablet computer during the skin prick test.
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Children watched a self-selected, age-appropriate animated cartoon on a tablet computer during the skin prick test.
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Experimental: DistrACTION® Cards group (DC)
Children viewed DistrACTION® Cards and answered goal-directed visual-search questions asked by the researcher during the skin prick test.
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Children viewed DistrACTION® Cards and answered goal-directed visual-search questions asked by the researcher during the skin prick test.
|
|
Experimental: Video game group (VG)
Children played a self-selected interactive video game on a tablet with the non-tested arm during the skin prick test.
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Children played a self-selected interactive video game on a tablet with the non-tested arm during the skin prick test.
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No Intervention: Control group (C)
Children received the clinic's standard protocol; the nurse explained and performed the test, and no additional distraction was provided.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child-reported procedural pain
Time Frame: 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).
|
During the skin prick test, a procedure lasting approximately 3 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child-reported pain after the procedure
Time Frame: 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).
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Immediately after the skin prick test, up to 15 minutes after the procedure
|
|
Parent-reported pain
Time Frame: 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).
|
During the skin prick test (approximately 3 minutes) and immediately after the procedure (up to 15 minutes)
|
|
Researcher-reported pain
Time Frame: 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).
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During the skin prick test (approximately 3 minutes) and immediately after the procedure (up to 15 minutes)
|
|
Parent-reported 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)
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Anxiety reported by the parent using the Children's Fear Scale (0 = no anxiety to 4 = severe anxiety; higher scores indicate higher anxiety).
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Approximately 10 minutes before the skin prick test, during the test (approximately 3 minutes), and immediately after the procedure (up to 15 minutes)
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Researcher-reported 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)
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Anxiety reported by the researcher using the Children's Fear Scale (0 = no anxiety to 4 = severe anxiety; higher scores indicate higher anxiety).
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Approximately 10 minutes before the skin prick test, during the test (approximately 3 minutes), and immediately after the procedure (up to 15 minutes)
|
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Interrater agreement
Time Frame: During the skin prick test (approximately 3 minutes) and immediately after the procedure (up to 15 minutes)
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Intraclass correlation coefficient between child, parent, and researcher ratings.
|
During the skin prick test (approximately 3 minutes) and immediately after the procedure (up to 15 minutes)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Leyla Erdim, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 7, 2019
Primary Completion (Actual)
January 12, 2020
Study Completion (Actual)
January 21, 2020
Study Registration Dates
First Submitted
August 24, 2026
First Submitted That Met QC Criteria
August 26, 2026
First Posted (Actual)
August 31, 2026
Study Record Updates
Last Update Posted (Actual)
August 31, 2026
Last Update Submitted That Met QC Criteria
August 26, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-19-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data will not be shared.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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