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临床试验/NCT07755280
NCT07755280已完成不适用

Predictors of Sleep Quality in Patients Undergoing Open-Heart Surgery: A Hierarchical Regression Analysis

Aydin Adnan Menderes University1 个研究点 分布在 1 个国家目标入组 157 人开始时间: 2025年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
157
试验地点
1
主要终点
Pain

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

结局指标

主要结局

Pain

时间窗: 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.

Sleep quality

时间窗: 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.

Fatigue

时间窗: 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.

Environmental Stressors

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Aydin Adnan Menderes University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ezgi Arslan

PhD, Research Assisstant (Principal Investigator)

Aydin Adnan Menderes University

研究点 (1)

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