Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 3:49 AM
Study NCT ID:
NCT07441668
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comfort Intervention in PICU Children
Sponsor:
Ankara Yildirim Beyazıt University
Organization:
Study Overview
Official Title:
The Effect of a Kolcaba Comfort Theory-Based Child Comfort Intervention on Comfort, Anxiety, Fear, and Sleep in the Pediatric Intensive Care Unit: A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CCI-PICU
Brief 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.
Detailed Description:
This randomized controlled trial will be conducted in a PICU to evaluate the effectiveness of a family-centered comfort intervention based on Kolcaba's Comfort Theory. Eligible children and their parents will be enrolled after consent and randomly assigned to an intervention group or a control group.
The control group will receive routine nursing care. The intervention group will receive routine care plus a multidimensional comfort intervention including maternal voice exposure, environmental light regulation, and a weighted blanket.
Child outcomes will include comfort, anxiety, fear, and sleep parameters. Parent outcomes will include state anxiety and satisfaction with care. Assessments will be performed at baseline, 24 hours after admission, and 12 hours after completion of the intervention. The primary objective is to determine whether the intervention improves child comfort and related outcomes, and whether it positively affects parental anxiety and satisfaction compared with routine care.
The control group will receive routine nursing care. The intervention group will receive routine care plus a multidimensional comfort intervention including maternal voice exposure, environmental light regulation, and a weighted blanket.
Child outcomes will include comfort, anxiety, fear, and sleep parameters. Parent outcomes will include state anxiety and satisfaction with care. Assessments will be performed at baseline, 24 hours after admission, and 12 hours after completion of the intervention. The primary objective is to determine whether the intervention improves child comfort and related outcomes, and whether it positively affects parental anxiety and satisfaction compared with routine care.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: