- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07755280
Predictors of Sleep Quality in Patients Undergoing Open-Heart Surgery
2026년 8월 5일 업데이트: 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.
연구 개요
상태
완전한
정황
상세 설명
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.
연구 유형
관찰
등록 (실제)
157
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Zafer Mahallesi
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Aydin, Zafer Mahallesi, 터키 (Türkiye), 09010
- Aydın Adnan Menderes University
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
Patients admitted to the cardiovascular intensive care unit after open heart surgery
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pain
기간: At least 24 hours after admission to the intensive care unit
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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.
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At least 24 hours after admission to the intensive care unit
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Sleep quality
기간: At least 24 hours after admission to the intensive care unit
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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.
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At least 24 hours after admission to the intensive care unit
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Fatigue
기간: At least 24 hours after admission to the intensive care unit
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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.
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At least 24 hours after admission to the intensive care unit
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Environmental Stressors
기간: At least 24 hours after admission to the intensive care unit
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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.
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At least 24 hours after admission to the intensive care unit
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2025년 9월 15일
기본 완료 (실제)
2026년 3월 15일
연구 완료 (실제)
2026년 5월 15일
연구 등록 날짜
최초 제출
2026년 8월 5일
QC 기준을 충족하는 최초 제출
2026년 8월 5일
처음 게시됨 (실제)
2026년 8월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 10일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 5일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- Predictors of Sleep Quality
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
IPD 공유 기간
12 months after publication
IPD 공유 지원 정보 유형
- 연구_프로토콜
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .