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Completed

NCT Number: NCT07626047

Healing Care Environment and Sleep in Pediatric Intensive Care

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.

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Key information

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University Hospital Pediatric Intensive Care Unit

Izmir, Bornova, 35080, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

eye mask

Device

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

Other names: 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.

Other names: Headphones With Audiobook Group

Primary outcomes

  1. Sleep Disturbance Scale for Children Score

    Time frame: Up to 7 days during hospitalization

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

Secondary outcomes

  1. Heart Rate

    Time frame: Up to 7 days during hospitalization

    Heart rate values were monitored to evaluate physiological responses during the intervention process.

  2. Respiratory Rate

    Time frame: Up to 7 days during hospitalization

    Respiratory rate was monitored throughout the intervention process to assess physiological changes associated with sleep support interventions.

  3. Blood Pressure

    Time frame: Up to 7 days during hospitalization

    Systolic and diastolic blood pressure values were monitored during the study process.

  4. Oxygen Saturation

    Time frame: Up to 7 days during hospitalization

    Peripheral oxygen saturation levels were monitored to evaluate physiological stability during the intervention period.

  5. Body Temperature

    Time frame: Up to 7 days during hospitalization

    Body temperature values were monitored during the study process as part of physiological parameter assessment.

  6. Oxygen Requirement

    Time frame: Up to 7 days during hospitalization

    Oxygen flow requirement (L/min) was monitored during the study process to evaluate respiratory support needs and physiological stability during the interventions.

Sponsors and collaborators

Lead sponsor

Burçak Bahadır

Other

Registry information

Official study title

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

Acronym: HEALSLEEP

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 4, 2026
Registry last updated
Jun 4, 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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