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NCT07033546
The Effect of Using Toy Bracelets During Physical Restraint in a Pediatric Intensive Care Unit on Children's Physiological Parameters, Fear, and Anxiety Levels
NA trial testing Toy bracelets in Pediatric Intensive Care Unit in 65 participants. Completed in 8 April 2025.
30 December 2024
Quick facts
| Lead sponsor | Trakya University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 65 |
| Start date | 1 December 2023 |
| Primary completion | 30 December 2024 |
| Estimated completion | 8 April 2025 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Toy bracelets
Conditions studied
- Pediatric Intensive Care Unit — all drugs for Pediatric Intensive Care Unit →
- Physical Restraint — all drugs for Physical Restraint →
- Anxiety — all drugs for Anxiety →
- Fear — all drugs for Fear →
Sponsor
Trakya University
Who can join
Adults 4 to 12, any sex, with Pediatric Intensive Care Unit or Physical Restraint. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07033546
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Pediatric Intensive Care Unit
Currently open trials in the same condition.
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Other Trakya University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07033546 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Trakya University
- Last refreshed: 24 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07033546.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing