Comfort Intervention in PICU Children

NCT07441668 | Recruiting

• 1 other identifier: 2025/262
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Comfort; Anxiety in Children; Fear; Pediatric Intensive Care Unit; Sleep

Keywords

Pediatric intensive care; Child comfort; Kolcaba Comfort Theory; Anxiety; Fear; Sleep

Outcome Measures

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.

  Baseline; 24 hours after admission; 12 hours after intervention

Secondary Outcomes (7)

• Children's Fear Scale (CFS) Five-Face Visual Self-Report Fear Scale Total Score (0-4)

  Baseline; 24 hours after admission; 12 hours after intervention

• Child Anxiety Meter (CAM) Visual Analog Scale Total Score (0-10)

  Baseline; 24 hours after admission; 12 hours after intervention

• Spielberger State Anxiety Inventory (STAI-S) Parent Total Score (20-80)

  Baseline; 12 hours after intervention

• Pediatric Quality of Life Inventory (PedsQL) Healthcare Satisfaction Parent Report Total Score (0-100)

  24 hours after admission; 12 hours after intervention

• Total Sleep Duration Measured by Wrist Actigraphy (minutes)

  24 hours after admission; 12 hours after intervention

Study Arms (2)

Intervention Group - Family-Centered Comfort

EXPERIMENTAL

Children receive a multifaceted, family-centered comfort intervention including storytelling using the mother's voice, dimmed lighting, and weighted blanket. Outcomes measured include child comfort, anxiety, fear, sleep, and parent anxiety and satisfaction.

Behavioral: Intervention Family-Centered Comfort

Control Group - Standard Care

OTHER

Children receive standard care in the PICU without the additional comfort interventions. Outcomes measured are the same as the intervention group for comparison purposes.

Other: Standard Care (in control arm)

Interventions

Intervention Family-Centered Comfort BEHAVIORAL

Storytelling with the mother's voice, dimmed lighting, and weighted blanket administered by the researcher to children in the intervention group.

Intervention Group - Family-Centered Comfort

Standard Care (in control arm) OTHER

Routine care provided to children in the control group without additional comfort interventions.

Control Group - Standard Care

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Ordu Universitesi Egitim ve Arastirma Hastanesi

Ordu, Altınordu, 52200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned to either the intervention group, receiving a multifaceted, family-centered comfort intervention, or the control group, receiving standard care. Outcomes are compared between groups to assess the effectiveness of the intervention on child comfort, anxiety, fear, and sleep, as well as parent anxiety and satisfaction.

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: March 2, 2026
• Study Start: February 20, 2026
• Primary Completion: May 15, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-02

Locations

TU (1)