Healing Care Environment and Sleep in Pediatric Intensive Care

NCT07626047 | Completed

• 1 other identifier: EGE-PICU-SLEEP-RCT-2025
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled study was conducted to evaluate the effects of non-pharmacological interventions used within the framework of a healing care environment on sleep disturbances in children hospitalized in the pediatric intensive care unit (PICU). The study aimed to support sleep quality by reducing environmental stimuli and promoting comfort through supportive nursing interventions. The interventions included the use of an eye mask and headphones with audiobooks in addition to standard nursing care. Children aged 6-15 years who met the inclusion criteria were randomly assigned to control and intervention groups. Sleep disturbances were evaluated using the Sleep Disturbance Scale for Children, and physiological parameters including heart rate, respiratory rate, blood pressure, oxygen saturation, and body temperature were monitored throughout the study process. The findings of this study are expected to contribute to evidence-based non-pharmacological nursing interventions aimed at improving sleep quality and supportive care practices in the PICU environment.

Conditions

Healing Care Environment; Sleep Quality; Sleep Disturbance; Pediatric Intensive Care Unit

Keywords

Children; Sleep; Sleep mask; Audiobook; Pediatric Intensive Care Unıt; Healing Care Environment; Sleep Disturbance; Non-Pharmacological Intervention; Pediatric Nursing

Outcome Measures

Primary Outcomes (1)

• Sleep Disturbance Scale for Children Score

  Sleep disturbances in children hospitalized in the pediatric intensive care unit were evaluated using the Sleep Disturbance Scale for Children.

  Up to 7 days during hospitalization

Secondary Outcomes (6)

• Heart Rate

  Up to 7 days during hospitalization

• Respiratory Rate

  Up to 7 days during hospitalization

• Blood Pressure

  Up to 7 days during hospitalization

• Oxygen Saturation

  Up to 7 days during hospitalization

• Body Temperature

  Up to 7 days during hospitalization

Study Arms (3)

Standard Care Group

NO INTERVENTION

Children in this group received routine pediatric intensive care nursing care without any additional non-pharmacological sleep-support intervention during the study period.

Eye Mask Group

EXPERIMENTAL

Children in this group received routine pediatric intensive care nursing care in addition to the use of an eye mask during the sleep period in order to reduce environmental light stimuli and support sleep quality.

Device: Eye Mask

Headphones With Audiobook Group

EXPERIMENTAL

Children in this group received routine pediatric intensive care nursing care in addition to listening to age-appropriate and calming audiobooks through headphones during the sleep period in order to promote relaxation and support sleep quality.

Behavioral: Audiobook Through Headphones

Interventions

Eye Mask DEVICE

Eye masks were used during the sleep period to reduce environmental light stimuli and support sleep quality.

Also known as: Eye Mask Group

Eye Mask Group

Audiobook Through Headphones BEHAVIORAL

Age-appropriate calming audiobooks were provided through headphones during the sleep period to support relaxation and sleep quality.

Also known as: Headphones With Audiobook Group

Headphones With Audiobook Group

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Being between 6 and 15 years of age
• Being hospitalized in the pediatric intensive care unit
• Not being intubated
• Not being monitored under sedation
• Having a Glasgow Coma Scale (GCS) score of 13 or higher
• Obtaining written and verbal informed consent from the child and the legal guardian

You may not qualify if:

• Presence of neurological disorders (e.g., cerebral palsy, epilepsy, neuromuscular diseases, mental retardation)
• Active central nervous system infection (meningitis, encephalitis) or sepsis
• Presence of visual or hearing impairment
• Continuous use of medications that may affect sleep patterns (e.g., anticonvulsants, antidepressants, antihistamines)
• Administration of sedative medication during the follow-up period
• Length of stay in the pediatric intensive care unit being less than three days

Sponsors & Collaborators

• Burçak Bahadır: lead

Study Sites (1)

Ege University Hospital Pediatric Intensive Care Unit

Izmir, Bornova, 35080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parasomnias; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Nurdan Akçay Didişen, Associate Professor

  Ege University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor was blinded to group allocation during the evaluation of study outcomes.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Pediatric Nurse, Master's Student in Child Health and Diseases Nursing

Model Details: Participants were assigned to groups using a block randomization method and were randomly allocated to one of three parallel groups: the standard care group, the eye mask intervention group, or the headphones with audiobook intervention group. Each participant received only the intervention assigned to their group throughout the study period. The interventions were applied in parallel during the hospitalization period, and the effects of the interventions on sleep disturbances and physiological parameters were compared between the groups.

Study Record Dates

• First Submitted: May 31, 2026
• First Posted: June 4, 2026
• Study Start: February 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)