An interventional study of Smartphone-Based Cartoon Distraction and Standard Cast Removal Care in Anxiety and Fear, sponsored by Caner Oguk. Completed at 1 site in Turkey (Türkiye). Open to participants aged 4 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Caner Oguk · Not applicable, Interventional, and Supportive care
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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.
Children aged 4 to 12 years undergoing removal of a short- or long-arm circumferential cast were included in this single-center randomized controlled trial. Eligible participants were assigned to either a control group or a smartphone-based distraction group.
In the control group, children underwent the routine cast-removal procedure after they and their families were informed about the procedure and the safety of the vibrating cast saw. In the intervention group, the same standard care was provided, and children additionally watched a standardized age-appropriate cartoon on a smartphone during cast removal. The selected cartoon was "Rafadan Tayfa, Episode 91: Health Guardians." No pharmacological agents were used for anxiety management in either group.
Fear, behavioral distress, and physiological response associated with cast removal were evaluated using the Children's Fear Scale, the Observational Scale of Behavioral Distress-Revised, and pulse rate measured by pulse oximetry.
7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's enrollment of 144 is above the median of 80 across 6,062 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →This is the only study on the registry with Caner Oguk as lead sponsor.
Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
The criteria were revised on the registry on Sep 30, 2026. See what changed
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Exclusion Criteria:
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
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
Participants watched a standardized age-appropriate cartoon on a smartphone during the cast-removal procedure as a passive distraction intervention.
Standard cast removal was performed after the child and family had been informed about the procedure and the safety of the vibrating cast saw.
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.
Time frame: During the cast-removal procedure
Study-Specific Modified Observational Scale of Behavioral Distress (mOSBD) Score During Cast Removal
Behavioral distress was assessed using a study-specific modified Observational Scale of Behavioral Distress (mOSBD), derived from the original OSBD behavioral domains. Eleven predefined behaviors were observed throughout the cast-removal procedure. Each behavior was recorded once as either present (assigned a predefined weight) or absent (0), without interval-based or frequency-dependent scoring. Weighted scores were summed to obtain a total score ranging from 0 to 23.5, with higher scores indicating greater behavioral distress. This study-specific scoring method differs from the original validated OSBD and OSBD-R instruments.
Time frame: During the cast-removal procedure
Peak Pulse Rate During Cast Removal
Peak pulse rate during the cast-removal procedure was measured noninvasively using pulse oximetry as an objective physiological indicator of procedure-related stress. Values were recorded in beats per minute.
Time frame: During the cast-removal procedure
Plan to share: No — Individual participant data are not planned for public sharing.
No publications or documents are linked to this record.
Ran from Jan 2024 to primary completion in Sep 2025, 20 months.
Of 3,841 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 20 months is above that.
Counting every sponsor, half of 3,943 studies reached it within 12 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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