Smartphone-Based Cartoon Distraction During Cast Removal in Children

NCT07842627 | Completed

• 2 other identifiers: 2012-KAEK-15-2633_CAST_REMOVE2012-KAEK-15/2633
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

Cast removal can cause considerable fear and anxiety in children despite being a generally painless procedure. This randomized controlled trial evaluated whether watching a cartoon on a smartphone during circumferential upper-extremity cast removal reduces procedure-related fear and behavioral distress in children aged 4 to 12 years compared with standard care. Participants were randomly assigned in a 1:1 ratio to standard cast removal alone or standard cast removal combined with smartphone-based cartoon distraction. The primary outcome was fear assessed using the Children's Fear Scale (CFS). Secondary outcomes included behavioral distress assessed using the Observational Scale of Behavioral Distress-Revised (OSBD-R) and pulse rate measured by pulse oximetry.

Conditions

Anxiety; Fear

Keywords

Smartphone; Casts, Surgical; Audiovisual Aids; Child, Preschool; Child; Anxiety; Fear

Outcome Measures

Primary Outcomes (1)

• Children's Fear Scale (CFS) Score

  Fear associated with the cast-removal procedure was assessed using the Children's Fear Scale (CFS), a five-face scale ranging from 0 to 4. Higher scores indicate greater fear.

  During the cast-removal procedure

Secondary Outcomes (2)

• Study-Specific Modified Observational Scale of Behavioral Distress (mOSBD) Score During Cast Removal

  During the cast-removal procedure

• Peak Pulse Rate During Cast Removal

  During the cast-removal procedure

Study Arms (2)

Standard Care

ACTIVE COMPARATOR

Participants underwent the standard cast-removal procedure after being informed about the procedure and the safety of the vibrating cast saw. No pharmacological anxiolytic intervention was used.

Other: Standard Cast Removal Care

Smartphone-Based Cartoon Distraction

EXPERIMENTAL

Participants underwent the same standard cast-removal procedure and additionally watched a standardized age-appropriate cartoon on a smartphone during cast removal. No pharmacological anxiolytic intervention was used.

Behavioral: Smartphone-Based Cartoon Distraction; Other: Standard Cast Removal Care

Interventions

Smartphone-Based Cartoon Distraction BEHAVIORAL

Participants watched a standardized age-appropriate cartoon on a smartphone during the cast-removal procedure as a passive distraction intervention.

Smartphone-Based Cartoon Distraction

Standard Cast Removal Care OTHER

Standard cast removal was performed after the child and family had been informed about the procedure and the safety of the vibrating cast saw.

Smartphone-Based Cartoon Distraction; Standard Care

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 4 to 12 years.
• Scheduled to undergo removal of a short-arm or long-arm circumferential plaster cast.
• Undergoing cast removal at the orthopedic outpatient clinic.

You may not qualify if:

• Presence of a neurological disorder that could affect the assessment of fear, anxiety, or behavioral responses.
• Presence of a cognitive disorder that could interfere with study participation or outcome assessment.

Sponsors & Collaborators

• Caner Oguk: lead

Study Sites (1)

Ankara Atatürk Sanatorium Training and Research Hospital

Ankara, Ankara, 06380, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Orthopaedic Surgeon - Sub Investigator

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 25, 2026
• Study Start: January 15, 2024
• Primary Completion: September 17, 2025
• Study Completion: September 17, 2025
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)