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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 86
- Locations
- 1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Masking Description
Children aged 5-10 who meet the inclusion criteria will be randomly assigned to intervention and control groups. Parents will provide written informed consent via a consent form without being informed of group allocation. Since the intervention (storytelling using the mother's voice, dimmed lighting, and weighted blanket) is administered directly by the researcher, the researcher cannot be blinded. To minimize detection bias, outcome assessments (child comfort, anxiety, fear, sleep, parent anxiety, and satisfaction with care) will be performed by two independent, university-educated nurses working in the PICU who are unaware of the group assignments. Inter-rater reliability between the two nurses will be evaluated, and the mean of their measurements will be used for analysis. To reduce bias during data analysis, group information will be coded as A and B by an individual outside the research team. Statistical analyses will be conducted by an independent statistician blinded to group id
Eligibility Criteria
- Ages
- 5 Years to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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