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Sleep DisturbanceHEALSLEEPNCT07626047

Healing Care Environment and Sleep in Pediatric Intensive Care

A study testing Eye Mask and Audiobook Through Headphones in people with Sleep Disturbance and Pediatric Intensive Care Unit, run by Burçak Bahadır at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 6 to 15 years
What is being tested?
Eye Mask and Audiobook Through Headphones
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Feb 2025to 30 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ege University Hospital Pediatric Intensive Care Unit

    Izmir, Bornova, 35080

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
Eye Mask, Audiobook Through Headphones
Keywords
Children, Sleep, Sleep mask, Audiobook, Pediatric Intensive Care Unıt, Healing Care Environment, Sleep Disturbance, Non-Pharmacological Intervention, Pediatric Nursing
Medical subject headings
Parasomnias, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Eye MaskDevice

    Also called Eye Mask Group

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

  • Audiobook Through HeadphonesBehavioural

    Also called Headphones With Audiobook Group

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

Study groups in NCT07626047
Study groupRoleWhat they receive
Standard Care GroupNo interventionChildren in this group received routine pediatric intensive care nursing care without any additional non-pharmacological sleep-support intervention during the study period.
Eye Mask GroupExperimentalChildren 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.
Receives: Device: Eye Mask
Headphones With Audiobook GroupExperimentalChildren 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.
Receives: Behavioral: Audiobook Through Headphones

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 7 days during hospitalization

Secondary outcomes (6)
  1. Heart Rate

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

    Measured: Up to 7 days during hospitalization

  2. Respiratory Rate

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

    Measured: Up to 7 days during hospitalization

  3. Blood Pressure

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

    Measured: Up to 7 days during hospitalization

  4. Oxygen Saturation

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

    Measured: Up to 7 days during hospitalization

  5. Body Temperature

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

    Measured: Up to 7 days during hospitalization

  6. Oxygen Requirement

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

    Measured: Up to 7 days during hospitalization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2026
  2. Study start1 Feb 2025
  3. Primary completion30 Nov 2025
  4. Study completion30 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07626047
Sponsor's protocol ID
EGE-PICU-SLEEP-RCT-2025
Acronym
HEALSLEEP
Status last verified
May 2026
First submitted
31 May 2026
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared due to privacy and confidentiality considerations related to pediatric intensive care patients.

Questions about this trial

What is this clinical trial studying?

A study testing Eye Mask and Audiobook Through Headphones in people with Sleep Disturbance and Pediatric Intensive Care Unit, run by Burçak Bahadır at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sleep Disturbance Scale for Children Score (time frame: Up to 7 days during hospitalization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.

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