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

31 de maio de 2026 atualizado por: 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.

Visão geral do estudo

Descrição detalhada

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 de estudo

Intervencional

Inscrição (Real)

42

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Sem intervenção: 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.
Eye masks were used during the sleep period to reduce environmental light stimuli and support sleep quality.
Outros nomes:
  • 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.
Age-appropriate calming audiobooks were provided through headphones during the sleep period to support relaxation and sleep quality.
Outros nomes:
  • Headphones With Audiobook Group

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Sleep Disturbance Scale for Children Score
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Heart Rate
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Diretor de estudo: Nurdan Akçay Didişen, Associate Professor, Ege university

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de fevereiro de 2025

Conclusão Primária (Real)

30 de novembro de 2025

Conclusão do estudo (Real)

30 de dezembro de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

31 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

31 de maio de 2026

Primeira postagem (Real)

4 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

4 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

31 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

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

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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