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Recruiting NCT07441668

Comfort Intervention in PICU Children

No phase Interventional Pediatric Intensive Care Unit Comfort Anxiety in Children Fear

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intervention Family-Centered Comfort, Standard Care (in control arm).
Who it may be relevant to
Registry conditions: Pediatric Intensive Care Unit, Comfort, Anxiety in Children, Fear. Basic parameters: 5 years — 10 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • 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 Standard Care (in control arm)
    Routine care provided to children in the control group without additional comfort interventions.

Primary outcome measures

  • COMFORT-B Behavioral Comfort Scale Total Score (6-30) [Time frame: Baseline; 24 hours after admission; 12 hours after intervention]
Secondary outcome measures (7)
  • 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]
  • Child Anxiety Meter (CAM) Visual Analog Scale Total Score (0-10) [Time frame: 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]
  • Pediatric Quality of Life Inventory (PedsQL) Healthcare Satisfaction Parent Report Total Score (0-100) [Time frame: 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]
  • Number of Night Awakenings Measured by Wrist Actigraphy (count) [Time frame: 24 hours after admission; 12 hours after intervention]
  • Sleep Efficiency Measured by Wrist Actigraphy (%) [Time frame: 24 hours after admission; 12 hours after intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Ordu Universitesi Egitim ve Arastirma Hastanesi — Ordu

Identifiers

NCT: NCT07441668 · 2025/262

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗