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

NCT07796087 | Completed

• 1 other identifier: 2019-19-01
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

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.

Conditions

Procedural Pain; Procedural Anxiety

Keywords

child; distraction; skin prick test; video games; cartoons; distraction cards

Outcome Measures

Primary Outcomes (1)

• 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).

  During the skin prick test, a procedure lasting approximately 3 minutes

Secondary Outcomes (6)

• Child-reported pain after the procedure

  Immediately after the skin prick test, up to 15 minutes after the procedure

• Parent-reported pain

  During the skin prick test (approximately 3 minutes) and immediately after the procedure (up to 15 minutes)

• Researcher-reported pain

  During the skin prick test (approximately 3 minutes) and immediately after the procedure (up to 15 minutes)

• 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)

• 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)

Study Arms (4)

Cartoon group (CG)

EXPERIMENTAL

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

Behavioral: Animated cartoon distraction

DistrACTION® Cards group (DC)

EXPERIMENTAL

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

Behavioral: Distraction card intervention

Video game group (VG)

EXPERIMENTAL

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

Behavioral: Interactive video game distraction

Control group (C)

NO INTERVENTION

Children received the clinic's standard protocol; the nurse explained and performed the test, and no additional distraction was provided.

Interventions

Animated cartoon distraction BEHAVIORAL

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

Cartoon group (CG)

Distraction card intervention BEHAVIORAL

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

DistrACTION® Cards group (DC)

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.

Video game group (VG)

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Neurodevelopmental conditions (diagnosis of autism or intellectual disability)
• Chronic mental, cognitive, or visual problems
• Cognitive, visual, or hearing impairment preventing scale use

Sponsors & Collaborators

• Istanbul University: lead
• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: collaborator

Study Sites (1)

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Leyla Erdim

  Bakirkoy Dr. Sadi Konuk Research and Training Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 31, 2026
• Study Start: November 7, 2019
• Primary Completion: January 12, 2020
• Study Completion: January 21, 2020
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)