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Comfort Intervention in PICU Children

NCT07441668 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2026-05-12

No results posted yet for this study

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

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

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.

Sponsors & Collaborators

  • Ankara Yildirim Beyazıt University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-20
Primary Completion
2026-05-15
Completion
2027-07-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07441668 on ClinicalTrials.gov