Pediatric Intensive Care UnitNCT07033546
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 study testing Toy bracelets in people with Pediatric Intensive Care Unit and Physical Restraint, run by Trakya University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Pediatric Intensive Care Unit, Physical Restraint, Anxiety
- What is being tested?
- Toy bracelets
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 8 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Pediatric Intensive Care Unit, Physical Restraint, Anxiety, Fear
- Being tested
- Toy bracelets
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toy braceletsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Not described |
| Intervention Group | Experimental | Not described Receives: Behavioral: Toy bracelets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children Fear Scale
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.
Measured: Fear was assessed at baseline and at the first, second, and third hours after admission of the children.
Child Anxiety State Scale
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.
Measured: Anxiety was assessed at baseline and at the first, second, and third hours after admission of the children.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start1 Dec 2023
- Primary completion30 Dec 2024
- Study completion8 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Intensive Care UnitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Remziye Semerci, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033546
- Sponsor's protocol ID
- OKAN_UNV
- Status last verified
- Jun 2025
- First submitted
- 5 Jun 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07033546
- Acronym / sponsor ID
- OKAN_UNV
- Conditions
- Pediatric Intensive Care Unit, Physical Restraint, Anxiety, Fear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 8 Apr 2025 (actual)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | – |
| Intervention Group | Experimental | Behavioral: Toy bracelets |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toy braceletsThe 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. | Behavioural | Intervention Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Pediatric Intensive Care Unit
Not yet recruitingObservational study
Platelet Transfusion Thresholds in Non-Bleeding Patients
Non Bleeding Patients With Thrombocytopenia
Not yet recruitingObservational study
PICS-p Longitudinal Cohort Study
Physical Functional Impairment, Cognitive Impairment
Not yet recruitingObservational study
pSOFA Score in Predicting Mortality in Pediatric Intensive Care
Critical Illness, Multiple Organ Dysfunction Syndrome
Recruiting
Probiotic Role in Prevention of Ventilator Associated Pneumonia in Critically- Ill Children Admitted at Pediatric Intensive Care Unit
Probiotic, Ventilator Associated Pneumonia
Not yet recruitingPhase 3
Impact on Delirium of the Use of DEXmedetomidine as First-line Sedation in PEDIAtric Intensive Care
Delirium in the Intensive Care Unit
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toy bracelets in people with Pediatric Intensive Care Unit and Physical Restraint, run by Trakya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children Fear Scale (time frame: Fear was assessed at baseline and at the first, second, and third hours after admission of the children.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.