Comfort Intervention in PICU Children (NCT07441668) | Clinical Trial Compass
RecruitingNot Applicable
Comfort Intervention in PICU Children
Turkey (Türkiye)86 participantsStarted 2026-02-20
Plain-language summary
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. Outcomes include child comfort, anxiety, fear, and sleep parameters, as well as parental anxiety and satisfaction with care. The study will determine whether the intervention improves child and parent outcomes compared with routine care.
Who can participate
Age range
5 Years – 10 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:
* 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
Exclusion Criteria:
* 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
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.
1This trial is focused on measuring comfort, anxiety, fear, and sleep in children in the PICU using a behavioral scale — can you explain what kind of intervention my child would actually receive, and how it would fit into their existing care while they're in the ICU?
2Since this study is listed as Phase NA, which often means it's evaluating a care practice or comfort approach rather than a drug, what does that mean for what's already known about whether this intervention is safe and helpful for children in intensive care?
3The trial uses something called the COMFORT-B Behavioral Comfort Scale to measure outcomes — can you walk me through what that scale looks at, and how you would use those scores to make decisions about my child's care during the study?
4Given that my child is already dealing with the stress of being in the PICU, how would participating in this study change their daily experience, and is there any risk that it could add to their discomfort or disruption rather than reduce it?
5Are there standard comfort-care approaches already being used in this PICU that we could pursue without enrolling in the study, and how do those compare to what this trial is testing?
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
COMFORT-B Behavioral Comfort Scale Total Score (6-30)
Timeframe: Baseline; 24 hours after admission; 12 hours after intervention