The Effect of Using Toy Bracelets During Physical Restraint in a Pediatric Intensive Care Unit on… (NCT07033546) | Clinical Trial Compass
CompletedNot Applicable
The Effect of Using Toy Bracelets During Physical Restraint in a Pediatric Intensive Care Unit on Children's Physiological Parameters, Fear, and Anxiety Levels
Turkey (Türkiye)65 participantsStarted 2023-12-01
Plain-language summary
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.
Who can participate
Age range
4 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Children Fear Scale
Timeframe: Fear was assessed at baseline and at the first, second, and third hours after admission of the children.
2
Child Anxiety State Scale
Timeframe: Anxiety was assessed at baseline and at the first, second, and third hours after admission of the children.