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NCT Number: NCT07441668

Comfort Intervention in PICU Children

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.

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Key information

Conditions

Pediatric Intensive Care Unit Anxiety Disorders Anxiety in Children Comfort Fear Mental Disorders Sleep

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ordu Universitesi Egitim ve Arastirma Hastanesi

Ordu, Altınordu, 52200, Turkey (Türkiye)

Location status: Recruiting

Location contact

Mine Nur Temucin, PhD

CONTACT

[email protected]

90452 226 52 00

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Standard Care (in control arm)

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Ankara Yildirim Beyazıt University

Other

Registry information

Official study 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

Acronym: CCI-PICU

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 2, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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