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New treatment option for Pediatric Intensive Care Unit
Official title Comfort Intervention in PICU Children
ClinicalTrials.gov ID: NCT07441668
What this study is testing
- What it's testing
- This randomized controlled trial evaluates a family-centered comfort intervention for children hospitalized in a pediatric intensive care unit. The intervention consists of listening to the mother's voice, environmental light regulation, and use of a weighted blanket, delivered in addition to routine nursing care.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 10. Healthy volunteers may be eligible.
You may be able to join if
- Child aged 5-10 years
- Has not received intravenous sedation or anesthetic medication in the past 12 hours
- Expected to stay in the Pediatric Intensive Care Unit (PICU) for at least 48-72 hours
- Conscious and able to communicate
- Glasgow Coma Scale score of 15
You likely can't join if
- Mechanically ventilated or intubated
- Hearing impairment
- Visual impairment
- Hand motor limitations
- Severe or profound intellectual disability
- Epilepsy or history of seizures
See the full eligibility criteria
- Child aged 5-10 years
- Has not received intravenous sedation or anesthetic medication in the past 12 hours
- Expected to stay in the Pediatric Intensive Care Unit (PICU) for at least 48-72 hours
- Conscious and able to communicate
- Glasgow Coma Scale score of 15
- No pain as assessed by the Wong-Baker FACES Pain Rating Scale
- Written informed consent obtained from parent/legal guardian
- Child and parent able to communicate in Turkish
- No medical contraindications to non-pharmacological, non-interactive interventions
- Mechanically ventilated or intubated
- Hearing impairment
- Visual impairment
- Hand motor limitations
- Severe or profound intellectual disability
- Epilepsy or history of seizures
- Severe underweight
- Chronic respiratory disease
- Chronic cardiovascular disease
- Surgical implants
- Osteoporosis
- Diagnosis of sleep disorder
- Use of sleep medication
- Any physical or mental health condition that prevents communication
The study team makes the final eligibility decision.
Where it's taking place
- Ordu, Altınordu, Turkey (Türkiye)
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 10 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ordu, Altınordu, Turkey (Türkiye). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.