Comfort Intervention in PICU Children (CCI-PICU)

May 9, 2026 updated by: Ankara Yildirim Beyazıt University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Altınordu
      • Ordu, Altınordu, Turkey (Türkiye), 52200
        • Recruiting
        • Ordu Universitesi Egitim ve Arastirma Hastanesi
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group - Family-Centered Comfort
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
Storytelling with the mother's voice, dimmed lighting, and weighted blanket administered by the researcher to children in the intervention group.
Other: Control Group - Standard Care
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)
Routine care provided to children in the control group without additional comfort interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COMFORT-B Behavioral Comfort Scale Total Score (6-30)
Time Frame: Baseline; 24 hours after admission; 12 hours after intervention
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Children's Fear Scale (CFS) Five-Face Visual Self-Report Fear Scale Total Score (0-4)
Time Frame: Baseline; 24 hours after admission; 12 hours after intervention
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.
Baseline; 24 hours after admission; 12 hours after intervention
Child Anxiety Meter (CAM) Visual Analog Scale Total Score (0-10)
Time Frame: Baseline; 24 hours after admission; 12 hours after intervention
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.
Baseline; 24 hours after admission; 12 hours after intervention
Spielberger State Anxiety Inventory (STAI-S) Parent Total Score (20-80)
Time Frame: Baseline; 12 hours after intervention
20-item questionnaire measuring parental situational anxiety. Higher scores indicate higher anxiety.
Baseline; 12 hours after intervention
Pediatric Quality of Life Inventory (PedsQL) Healthcare Satisfaction Parent Report Total Score (0-100)
Time Frame: 24 hours after admission; 12 hours after intervention
25-item parent-reported questionnaire assessing satisfaction with healthcare services. Higher scores indicate greater satisfaction.
24 hours after admission; 12 hours after intervention
Total Sleep Duration Measured by Wrist Actigraphy (minutes)
Time Frame: 24 hours after admission; 12 hours after intervention
Total sleep time recorded using wrist actigraphy.
24 hours after admission; 12 hours after intervention
Number of Night Awakenings Measured by Wrist Actigraphy (count)
Time Frame: 24 hours after admission; 12 hours after intervention
Number of awakenings recorded using wrist actigraphy.
24 hours after admission; 12 hours after intervention
Sleep Efficiency Measured by Wrist Actigraphy (%)
Time Frame: 24 hours after admission; 12 hours after intervention
Percentage of time asleep while in bed recorded using wrist actigraphy.
24 hours after admission; 12 hours after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Yildirim Beyazıt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2026

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

January 14, 2026

First Submitted That Met QC Criteria

February 27, 2026

First Posted (Actual)

March 2, 2026

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/262

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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