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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Intervention Family-Centered Comfort
BehavioralStorytelling with the mother's voice, dimmed lighting, and weighted blanket administered by the researcher to children in the intervention group.
Standard Care (in control arm)
Other interventionRoutine care provided to children in the control group without additional comfort interventions.
Treatment groups
86 Participants
are divided into 2 treatment groupsGroup A: Intervention Group - Family-Centered ComfortExperimental treatment 1 intervention
Group B: Control Group - Standard CareOther 1 intervention
Trial outcomes
Primary outcomes
1
COMFORT-B Behavioral Comfort Scale Total Score (6-30)
Behavioral comfort assessed using the COMFORT-B Behavioral Comfort Scale. Six items scored from 1 to 5. Total score ranges from 6 to 30. Higher scores indicate lower comfort.
Time frame
Baseline; 24 hours after admission; 12 hours after interventionSecondary outcomes
1
Children's Fear Scale (CFS) Five-Face Visual Self-Report Fear Scale Total Score (0-4)
Fear intensity assessed using the validated Children's Fear Scale (CFS), a five-face visual self-report scale. Scores range from 0 (no fear) to 4 (extreme fear). Higher scores indicate greater fear.
Time frame
Baseline; 24 hours after admission; 12 hours after intervention2
Child Anxiety Meter (CAM) Visual Analog Scale Total Score (0-10)
Situational anxiety assessed using the Child Anxiety Meter (CAM), a thermometer-style visual analog scale ranging from 0 (no anxiety) to 10 (extreme anxiety). Higher scores indicate greater anxiety.
Time frame
Baseline; 24 hours after admission; 12 hours after intervention3
Spielberger State Anxiety Inventory (STAI-S) Parent Total Score (20-80)
20-item questionnaire measuring parental situational anxiety. Higher scores indicate higher anxiety.
Time frame
Baseline; 12 hours after intervention4
Pediatric Quality of Life Inventory (PedsQL) Healthcare Satisfaction Parent Report Total Score (0-100)
25-item parent-reported questionnaire assessing satisfaction with healthcare services. Higher scores indicate greater satisfaction.
Time frame
24 hours after admission; 12 hours after interventionSponsors and contacts
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Source ClinicalTrials.gov