- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07755280
Predictors of Sleep Quality in Patients Undergoing Open-Heart Surgery
5 de agosto de 2026 atualizado por: Ezgi Arslan, Aydin Adnan Menderes University
Predictors of Sleep Quality in Patients Undergoing Open-Heart Surgery: A Hierarchical Regression Analysis
Sleep quality is a complex and multidimensional phenomenon shaped by the interaction of patient characteristics, symptom burden, and environmental factors specific to the intensive care unit environment.
Despite this multidimensional nature, studies identifying predictors of sleep quality in intensive care units after cardiac surgery are limited.
Visão geral do estudo
Status
Concluído
Descrição detalhada
Sleep is a fundamental biological process necessary for maintaining physiological homeostasis, supporting immune function, and promoting healing.
Sleep quality is a multidimensional construct influenced by individual characteristics such as age and body mass index, as well as psychological factors like stress and anxiety, and environmental factors such as noise, light, lack of privacy, and care practices.
However, patients in intensive care units often experience poor sleep quality, characterized by reduced sleep duration, fragmented sleep, prolonged sleep latency, and frequent awakenings.
Poor sleep quality in intensive care units leads to a higher incidence of delirium and atrial fibrillation complications in patients during the postoperative period, delayed recovery time, negative impact on immune function, and prolonged stay in the intensive care unit.
Open heart surgery is a frequently performed operation in ischemic and non-ischemic heart diseases (valve diseases, aortic stenosis, and atrial septal defect, etc.) that requires close monitoring of patients in an intensive care environment after surgery.
Following these surgeries, physiological issues such as pain, surgical wound problems, fatigue, dyspnea, and sleep problems commonly experienced by patients in intensive care settings, and psychological issues such as anxiety, stress, fear of death negatively affect sleep quality.
In addition, individual characteristics such as age and body mass index (BMI) can also affect sleep quality in this patient population.
Poor sleep quality in intensive care units is a commonly reported problem by patients, but due to its multifaceted nature, it is often not effectively managed.
Although previous studies have reported the prevalence of sleep disorders in intensive care patients, most studies have failed to adopt a comprehensive and multifactorial approach that examines the variables affecting sleep quality individually.
This situation highlights the need for studies using multivariate analytical methods to identify independent predictors of sleep quality.
The aim of this study is to examine the predictors of sleep quality in patients undergoing open heart surgery and admitted to the cardiovascular surgery intensive care unit, using a multivariate approach.
Tipo de estudo
Observacional
Inscrição (Real)
157
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
-
-
Zafer Mahallesi
-
Aydin, Zafer Mahallesi, Turquia (Türkiye), 09010
- Aydın Adnan Menderes University
-
-
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
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Método de amostragem
Amostra Não Probabilística
População do estudo
Patients admitted to the cardiovascular intensive care unit after open heart surgery
Descrição
Inclusion Criteria:
- ability to understand and speak Turkish,
- willingness to participate in the study,
- having spent at least 24 hours in the intensive care unit, and
- having the cognitive ability to understand and answer questions.
Exclusion Criteria:
- having taken narcotic or sedative drugs within the last 48 hours,
- having a history of chronic diseases that can cause sleep problems such as Chronic Obstructive Pulmonary Disease or sleep apnea,
- having a psychiatric illness diagnosed by a physician,
- having a visual or hearing impairment.
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
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pain
Prazo: At least 24 hours after admission to the intensive care unit
|
Assessed wit Visual Analog Scale.
his scale is a unidimensional, self-report instrument measuring 10 cm in length.
The lower end corresponds to a score of 0, labeled 'no pain,' while the upper end corresponds to a score of 10, labeled 'unbearable pain.' Higher scores on the scale indicate greater severity of pain as reported by the patient.
|
At least 24 hours after admission to the intensive care unit
|
|
Sleep quality
Prazo: At least 24 hours after admission to the intensive care unit
|
Assessed with Richard- Campbell Sleep Questionnaire. he scale consists of 6 items assessing sleep quality, nocturnal sleep depth, frequency of awakening, ambient noise level, time spent awake, and sleep onset latency.
Each item is rated on a visual analog scale ranging from 0 to 100.
The total score obtained from the scale is divided by the number of items to calculate the scale score.
A scale score between 0 and 25 is interpreted as very poor sleep, while a score between 76 and 100 is interpreted as very good sleep.
|
At least 24 hours after admission to the intensive care unit
|
|
Fatigue
Prazo: At least 24 hours after admission to the intensive care unit
|
Assessed wit Visual Analog Scale.
his scale is a unidimensional, self-report instrument measuring 10 cm in length.
The lower end corresponds to a score of 0, labeled 'no fatigue,' while the upper end corresponds to a score of 10, labeled 'unbearable fatigue.'
Higher scores on the scale indicate greater severity of fatigue as reported by the patient.
|
At least 24 hours after admission to the intensive care unit
|
|
Environmental Stressors
Prazo: At least 24 hours after admission to the intensive care unit
|
Assessed with Intensive Care Unit Environmental Stressors Scale.
The scale is of a 4-point Likert type and consists of 42 items.
The minimum possible score is 42 and the maximum is 168.
Higher scores are interpreted as indicating a greater degree of being affected by environmental stressors.
|
At least 24 hours after admission to the intensive care unit
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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)
15 de setembro de 2025
Conclusão Primária (Real)
15 de março de 2026
Conclusão do estudo (Real)
15 de maio de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
5 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
5 de agosto de 2026
Primeira postagem (Real)
10 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
10 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
5 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Predictors of Sleep Quality
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Prazo de Compartilhamento de IPD
12 months after publication
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
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 .