The Effect of Using Toy Bracelets During Physical Restraint in a Pediatric Intensive Care Unit on Children's Physiological Parameters, Fear, and Anxiety Levels: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Children Fear Scale
研究概览
简要总结
This randomized controlled trial aimed to evaluate the effects of using toy bracelets during physical restraint on physiological parameters, fear, and anxiety levels in children aged 4 to 12 years in a pediatric intensive care unit. Conducted between December 2023 and December 2024 at Istanbul Şehit Prof. Dr. İlhan Varank Training and Research Hospital, the study included 65 children, with 32 in the intervention group and 33 in the control group. Data collection tools included the Child Information Form, Child Fear Scale, and State-Trait Anxiety Inventory for Children (STAI-C), along with calibrated devices for physiological monitoring. Assessments were carried out at baseline and during the first, second, and third hours of observation to evaluate the intervention's impact over time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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 between 4 and 12 years
- •Child is conscious
- •First admission to the intensive care unit
- •First-time experience of physical restraint
- •Parental consent for the child's participation in the study
排除标准
- •Intubated patients
- •Presence of burns, wounds, or similar conditions on the limb to be restrained
- •Hearing impairment
- •Known mental illness
- •Deep sedation administered (exceeding ketamine 1 mg/kg or midazolam 0.5 mg/kg)
- •Presence or suspicion of cranial or any other type of bleeding
- •Neurological disorder
- •Terminal stage of illness
研究组 & 干预措施
Control Group
Intervention Group
干预措施: Toy bracelets (Behavioral)
结局指标
主要结局
Children Fear Scale
时间窗: Fear was assessed at baseline and at the first, second, and third hours after admission of the children.
The Child Fear Scale consists of six facial expressions scored from 0 (no fear) to 10 (highest fear) in increments of two. Fear increases progressively across the faces. Its validity and reliability were confirmed by Avşan et al. (2024), and it aligns with pain scales in format and scoring.
Child Anxiety State Scale
时间窗: Anxiety was assessed at baseline and at the first, second, and third hours after admission of the children.
The Child Anxiety State Scale (CAS-S), developed by Ersig et al. (2013), was validated in Turkish by Özalp Gerçeker et al. (2019). Designed for children aged 4-10, it resembles a thermometer and measures current anxiety ("right now"). The scale has strong psychometric properties and is suitable for clinical use.
次要结局
未报告次要终点
研究者
Remziye Semerci
Principal Investigator
Koç University