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临床试验/NCT07842627
NCT07842627已完成不适用

Does Watching Cartoons During Circular Cast Removal Reduce Anxiety and Fear in Children?

Caner Oguk1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2024年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
144
试验地点
1
主要终点
Children's Fear Scale (CFS) Score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
4 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

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

研究组 & 干预措施

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.

干预措施: Standard Cast Removal Care (Other)

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.

干预措施: Smartphone-Based Cartoon Distraction (Behavioral)

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.

干预措施: Standard Cast Removal Care (Other)

结局指标

主要结局

Children's Fear Scale (CFS) Score

时间窗: 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.

次要结局

  • Observational Scale of Behavioral Distress-Revised (OSBD-R) Score(During the cast-removal procedure)
  • Peak Pulse Rate During Cast Removal(During the cast-removal procedure)

研究者

发起方
Caner Oguk
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Caner Oguk

MD

Ankara Ataturk Sanatorium Training and Research Hospital

研究点 (1)

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