Skip to main content
OpenTrials
Completed

NCT Number: NCT07796087

Three Distraction Techniques for Pain and Anxiety in Children During Allergy Skin Prick Testing

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Procedural Pain Neurologic Manifestations Pain Pain, Procedural Pathological Conditions, Signs and Symptoms Procedural Anxiety Signs and Symptoms

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Animated cartoon distraction

Behavioral

Children watched a self-selected, age-appropriate animated cartoon on a tablet computer during the skin prick test.

Distraction card intervention

Behavioral

Children viewed DistrACTION® Cards and answered goal-directed visual-search questions asked by the researcher during the skin prick test.

Interactive video game distraction

Behavioral

Children played a self-selected interactive video game on a tablet with the non-tested arm during the skin prick test.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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)

    Anxiety reported by the parent using the Children's Fear Scale (0 = no anxiety to 4 = severe anxiety; higher scores indicate higher anxiety).

  5. 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)

    Anxiety reported by the researcher using the Children's Fear Scale (0 = no anxiety to 4 = severe anxiety; higher scores indicate higher anxiety).

  6. Interrater agreement

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Collaborators

  • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Registry information

Official study title

The Effect of Three Different Distraction Techniques on Anxiety and Pain Levels in Children During Allergy Skin Prick Testing: A Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.