The Effect of Using Toy Bracelets During Physical Restraint in a Pediatric Intensive Care Unit on Children's Physiological Parameters, Fear, and Anxiety Levels

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.

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Key information

Conditions

Pediatric Intensive Care Unit Anxiety Anxiety Disorders Fear Mental Disorders Physical Restraint

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Koç University

Istanbul, 34010, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Toy bracelets

Behavioral

The intervention involves the use of colorful, child-friendly toy bracelets worn by children during procedures requiring physical restraint in the pediatric intensive care unit. These bracelets are designed to offer a sense of familiarity, distraction, and emotional comfort during potentially distressing experiences. Unlike standard care, which involves restraint without any therapeutic distraction tools, the toy bracelets serve as a non-pharmacological, low-cost, and easily applicable intervention aimed at reducing emotional distress. The intervention is distinguished by its simplicity, immediate usability, and focus on integrating play-based elements into clinical care to address the psychological needs of hospitalized children.

Primary outcomes

Children Fear Scale

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Trakya University

Other

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2025
First posted: Jun 24, 2025
Registry last updated: Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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