- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07626047
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.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Bornova
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Izmir, Bornova, Tyrkiet (Türkiye), 35080
- Ege University Hospital Pediatric Intensive Care Unit
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: 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.
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Eksperimentel: 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.
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Eye masks were used during the sleep period to reduce environmental light stimuli and support sleep quality.
Andre navne:
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|
Eksperimentel: 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.
|
Age-appropriate calming audiobooks were provided through headphones during the sleep period to support relaxation and sleep quality.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Sleep Disturbance Scale for Children Score
Tidsramme: Up to 7 days during hospitalization
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Sleep disturbances in children hospitalized in the pediatric intensive care unit were evaluated using the Sleep Disturbance Scale for Children.
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Up to 7 days during hospitalization
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Heart Rate
Tidsramme: Up to 7 days during hospitalization
|
Heart rate values were monitored to evaluate physiological responses during the intervention process.
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Up to 7 days during hospitalization
|
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Respiratory Rate
Tidsramme: Up to 7 days during hospitalization
|
Respiratory rate was monitored throughout the intervention process to assess physiological changes associated with sleep support interventions.
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Up to 7 days during hospitalization
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Blood Pressure
Tidsramme: Up to 7 days during hospitalization
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Systolic and diastolic blood pressure values were monitored during the study process.
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Up to 7 days during hospitalization
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Oxygen Saturation
Tidsramme: Up to 7 days during hospitalization
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Peripheral oxygen saturation levels were monitored to evaluate physiological stability during the intervention period.
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Up to 7 days during hospitalization
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Body Temperature
Tidsramme: Up to 7 days during hospitalization
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Body temperature values were monitored during the study process as part of physiological parameter assessment.
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Up to 7 days during hospitalization
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Oxygen Requirement
Tidsramme: Up to 7 days during hospitalization
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Oxygen flow requirement (L/min) was monitored during the study process to evaluate respiratory support needs and physiological stability during the interventions.
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Up to 7 days during hospitalization
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Nurdan Akçay Didişen, Associate Professor, Ege University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- EGE-PICU-SLEEP-RCT-2025
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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