- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07755280
Predictors of Sleep Quality in Patients Undergoing Open-Heart Surgery
5 de agosto de 2026 actualizado 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.
Descripción general del estudio
Estado
Terminado
Descripción detallada
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 estudio
De observación
Inscripción (Actual)
157
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Zafer Mahallesi
-
Aydin, Zafer Mahallesi, Turquía (Türkiye), 09010
- Aydın Adnan Menderes University
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
Patients admitted to the cardiovascular intensive care unit after open heart surgery
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pain
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
15 de septiembre de 2025
Finalización primaria (Actual)
15 de marzo de 2026
Finalización del estudio (Actual)
15 de mayo de 2026
Fechas de registro del estudio
Enviado por primera vez
5 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
5 de agosto de 2026
Publicado por primera vez (Actual)
10 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
5 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Predictors of Sleep Quality
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Marco de tiempo para compartir IPD
12 months after publication
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .