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

Trakya University

Status: Completed

Conditions: Fear; Pediatric Intensive Care Unit; Anxiety; Physical Restraint

Treatments: Behavioral: Toy bracelets

Study type: Interventional

Funder types: Other

Identifiers

NCT07033546

OKAN_UNV

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: All

Ages: 4 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 2 patient groups

Control Group

No Intervention group

Intervention Group

Experimental group

Treatment:

Behavioral: Toy bracelets