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

31 maggio 2026 aggiornato da: Burçak Bahadır

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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

42

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: 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.
Sperimentale: 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.
Eye masks were used during the sleep period to reduce environmental light stimuli and support sleep quality.
Altri nomi:
  • Eye Mask Group
Sperimentale: 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.
Altri nomi:
  • Headphones With Audiobook Group

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Sleep Disturbance Scale for Children Score
Lasso di tempo: 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.
Up to 7 days during hospitalization

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Heart Rate
Lasso di tempo: Up to 7 days during hospitalization
Heart rate values were monitored to evaluate physiological responses during the intervention process.
Up to 7 days during hospitalization
Respiratory Rate
Lasso di tempo: Up to 7 days during hospitalization
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
Lasso di tempo: Up to 7 days during hospitalization
Systolic and diastolic blood pressure values were monitored during the study process.
Up to 7 days during hospitalization
Oxygen Saturation
Lasso di tempo: Up to 7 days during hospitalization
Peripheral oxygen saturation levels were monitored to evaluate physiological stability during the intervention period.
Up to 7 days during hospitalization
Body Temperature
Lasso di tempo: Up to 7 days during hospitalization
Body temperature values were monitored during the study process as part of physiological parameter assessment.
Up to 7 days during hospitalization
Oxygen Requirement
Lasso di tempo: 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.
Up to 7 days during hospitalization

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Direttore dello studio: Nurdan Akçay Didişen, Associate Professor, Ege University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 febbraio 2025

Completamento primario (Effettivo)

30 novembre 2025

Completamento dello studio (Effettivo)

30 dicembre 2025

Date di iscrizione allo studio

Primo inviato

31 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

31 maggio 2026

Primo Inserito (Effettivo)

4 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

31 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data will not be shared due to privacy and confidentiality considerations related to pediatric intensive care patients.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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