AnxietyCAST-REMOVENCT07842627
Smartphone-Based Cartoon Distraction During Cast Removal in Children
A study testing Smartphone-Based Cartoon Distraction and Standard Cast Removal Care in people with Anxiety and Fear, run by Caner Oguk at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 12 years
- What is being tested?
- Smartphone-Based Cartoon Distraction and Standard Cast Removal Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2024to 17 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Atatürk Sanatorium Training and Research Hospital
Ankara, Ankara, 06380
About this study
Official title: Does Watching Cartoons During Circular Cast Removal Reduce Anxiety and Fear in Children?
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.
Read the detailed description
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.
- Being tested
- Smartphone-Based Cartoon Distraction, Standard Cast Removal Care
- Keywords
- Smartphone, Casts, Surgical, Audiovisual Aids, Child, Preschool, Child, Anxiety, Fear
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone-Based Cartoon DistractionBehavioural
Participants watched a standardized age-appropriate cartoon on a smartphone during the cast-removal procedure as a passive distraction intervention.
Standard Cast Removal CareOther
Standard cast removal was performed after the child and family had been informed about the procedure and the safety of the vibrating cast saw.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Smartphone-Based Cartoon Distraction; Other: Standard Cast Removal Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the cast-removal procedure
Secondary outcomes (2)
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.
Measured: 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.
Measured: During the cast-removal procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start15 Jan 2024
- Primary completion17 Sep 2025
- Study completion17 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Caner Oguk
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Caner Oguk, Ankara Ataturk Sanatorium Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07842627
- Sponsor's protocol ID
- 2012-KAEK-15-2633_CAST_REMOVE
- Other IDs
- 2012-KAEK-15/2633
- Acronym
- CAST-REMOVE
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned for public sharing.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Watching Cartoons During Circular Cast Removal Reduce Anxiety and Fear in Children?
- ClinicalTrials.gov ID
- NCT07842627
- Acronym / sponsor ID
- CAST-REMOVE / 2012-KAEK-15-2633_CAST_REMOVE
- Keywords
- Smartphone, Casts, Surgical, Audiovisual Aids, Child, Preschool, Child, Anxiety, Fear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Caner OgukOther government
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 17 Sep 2025 (actual)
- Study completion
- 17 Sep 2025 (actual)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Active comparator | Other: Standard Cast Removal CareParticipants 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. |
| Smartphone-Based Cartoon Distraction | Experimental | Behavioral: Smartphone-Based Cartoon Distraction, Other: Standard Cast Removal CareParticipants 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. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone-Based Cartoon DistractionParticipants watched a standardized age-appropriate cartoon on a smartphone during the cast-removal procedure as a passive distraction intervention. | Behavioural | Smartphone-Based Cartoon Distraction |
| Standard Cast Removal CareStandard cast removal was performed after the child and family had been informed about the procedure and the safety of the vibrating cast saw. | Other | Smartphone-Based Cartoon Distraction, Standard Care |
Primary outcome
Children's Fear Scale (CFS) Score
Time frame: During the cast-removal procedure
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.
2 secondary outcomes
Study-Specific Modified Observational Scale of Behavioral Distress (mOSBD) Score During Cast Removal
Time frame: During the cast-removal procedure
Peak Pulse Rate During Cast Removal
Time frame: During the cast-removal procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data are not planned for public sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone-Based Cartoon Distraction and Standard Cast Removal Care in people with Anxiety and Fear, run by Caner Oguk at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Fear Scale (CFS) Score (time frame: During the cast-removal procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.