Healing Care Environment and Sleep in Pediatric Intensive Care (HEALSLEEP)

The Effect of Auditory Methods Used Within the Framework of Healing Care on Sleep Disorders in the Pediatric Intensive Care Unit

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.

Study Overview

• Status: Completed
• Conditions: Sleep Disturbance; Sleep Quality; Pediatric Intensive Care Unit; Healing Care Environment
• Intervention / Treatment: Device: Eye Mask; Behavioral: Audiobook Through Headphones

Detailed Description

This study was planned as a randomized controlled experimental study to evaluate the effects of non-pharmacological interventions applied within the framework of a healing care environment on sleep disturbances in children hospitalized in the pediatric intensive care unit (PICU). Sleep is one of the fundamental physiological needs that plays a critical role in growth, development, immune function, emotional regulation, cognitive processes, and recovery in children. However, sleep disturbances are frequently observed in pediatric intensive care units due to environmental and clinical factors such as continuous light exposure, high noise levels, monitor alarms, frequent nursing and medical interventions, pain, anxiety, stress, unfamiliar surroundings, and separation from family members. Inadequate and disrupted sleep may negatively affect physiological recovery, emotional well-being, comfort, healing processes, and overall quality of life in critically ill children.

In recent years, there has been increasing interest in non-pharmacological nursing interventions aimed at improving sleep quality and creating a healing care environment in intensive care settings. Within this framework, supportive interventions focused on reducing environmental stimuli and promoting comfort are considered important components of pediatric intensive care nursing care. Eye masks may contribute to sleep quality by reducing light exposure and supporting melatonin secretion, while auditory interventions such as calming audiobooks may help reduce anxiety, provide relaxation, and facilitate the transition to sleep. Despite increasing interest in such interventions, studies evaluating these methods comparatively in pediatric intensive care populations remain limited.

The study was conducted in the Pediatric Intensive Care Unit of Ege University Hospital. A total of 42 children were included in the study. Participants were assigned to groups using a block randomization method. The children were randomly assigned to three groups, with 14 children in each group: the standard care group, the eye mask intervention group, and the headphones with audiobook intervention group. The interventions were applied for a minimum of 3 days and a maximum of 7 days depending on the child's duration of hospitalization and clinical condition.

Children aged 6-15 years who were hospitalized in the pediatric intensive care unit, were not intubated, were not receiving sedative treatment, had a Glasgow Coma Scale score of 13 or higher, and met the study eligibility criteria were included in the study. Written informed consent was obtained from the parents or legal guardians of the children prior to participation. Children with severe neurological impairment, hearing or visual problems preventing the interventions, or clinical instability preventing participation were excluded from the study.

Children in the standard care group received routine pediatric intensive care nursing care. Children in the eye mask intervention group received routine nursing care in addition to the use of an eye mask during the sleep period in order to reduce environmental light stimuli. Children in the headphones with audiobook intervention group received routine nursing care in addition to listening to age-appropriate and calming audiobooks through headphones. The interventions were implemented during evening hours under nurse supervision by considering the children's clinical condition, individual tolerance, developmental characteristics, comfort level, and safety. The children's responses to the interventions were closely monitored throughout the process.

The primary outcome of the study was the evaluation of sleep disturbances using the Sleep Disturbance Scale for Children. Secondary outcomes included physiological parameters such as heart rate, respiratory rate, systolic and diastolic blood pressure, mean arterial pressure, oxygen saturation, oxygen requirement, and body temperature. Sociodemographic and clinical characteristics of the participants were also collected using a descriptive information form.

The findings of this study are expected to contribute to evidence-based pediatric nursing practices related to sleep support and healing care environments in pediatric intensive care units. Furthermore, the study aims to provide evidence regarding the effectiveness of non-pharmacological interventions in improving sleep quality and supporting holistic nursing care for critically ill children.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Bornova
    • Izmir, Bornova, Turkey (Türkiye), 35080
      • Ege University Hospital Pediatric Intensive Care Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Care Group; Children in this group received routine pediatric intensive care nursing care without any additional non-pharmacological sleep-support intervention during the study period.
Experimental: Eye Mask Group; 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; Eye masks were used during the sleep period to reduce environmental light stimuli and support sleep quality.; Other Names: Eye Mask Group
Experimental: Headphones With Audiobook Group; 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; Age-appropriate calming audiobooks were provided through headphones during the sleep period to support relaxation and sleep quality.; Other Names: Headphones With Audiobook Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate	Heart rate values were monitored to evaluate physiological responses during the intervention process.	Up to 7 days during hospitalization
Respiratory Rate	Respiratory rate was monitored throughout the intervention process to assess physiological changes associated with sleep support interventions.	Up to 7 days during hospitalization
Blood Pressure	Systolic and diastolic blood pressure values were monitored during the study process.	Up to 7 days during hospitalization
Oxygen Saturation	Peripheral oxygen saturation levels were monitored to evaluate physiological stability during the intervention period.	Up to 7 days during hospitalization
Body Temperature	Body temperature values were monitored during the study process as part of physiological parameter assessment.	Up to 7 days during hospitalization
Oxygen Requirement	Oxygen flow requirement (L/min) was monitored during the study process to evaluate respiratory support needs and physiological stability during the interventions.	Up to 7 days during hospitalization

Collaborators and Investigators

• Sponsor: Burçak Bahadır
• Investigators: Study Director: Nurdan Akçay Didişen, Associate Professor, Ege University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Actual): November 30, 2025
• Study Completion (Actual): December 30, 2025

Study Registration Dates

• First Submitted: May 31, 2026
• First Submitted That Met QC Criteria: May 31, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: May 31, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Children; Sleep; Sleep Disturbance; Pediatric Nursing; Non-Pharmacological Intervention; Sleep mask; Audiobook; Pediatric Intensive Care Unıt; Healing Care Environment
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Parasomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: EGE-PICU-SLEEP-RCT-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to privacy and confidentiality considerations related to pediatric intensive care patients.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No