Comfort Intervention in PICU Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-10
SponsorAnkara Yildirim Beyazıt University
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Mechanically ventilated or intubated
Hearing impairment
Visual impairment
Hand motor limitations
Trial design
Treatments tested in this trial
- Intervention Family-Centered Comfort
- Standard Care (in control arm)
Treatment groups
86 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov