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临床试验/NCT07747597
NCT07747597已完成不适用

Effect of a Structured Nursing Intervention Incorporating Sleep Hygiene and Cognitive-Behavioral Strategies on Sleep Quality Among Patients With Chronic Heart Failure

Al-Zaytoonah University of Jordan1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年6月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Sleep Quality

研究概览

简要总结

This study aims to evaluate the effectiveness of a structured nursing intervention incorporating sleep hygiene education and cognitive-behavioral strategies on improving sleep quality among patients with chronic heart failure. Sleep disturbances are common in patients with chronic heart failure and are associated with poorer functional status, reduced quality of life, and increased healthcare utilization. Participants will receive a structured nursing intervention that includes education on healthy sleep practices and cognitive-behavioral techniques to improve sleep.

详细描述

Chronic heart failure is a progressive cardiovascular condition that is frequently accompanied by sleep disturbances, including insomnia, fragmented sleep, and poor sleep quality. These sleep problems contribute to fatigue, impaired daily functioning, poor self-care, and reduced health-related quality of life. Although pharmacological treatment is essential for heart failure management, non-pharmacological interventions such as sleep hygiene education and cognitive-behavioral strategies have shown promise in improving sleep outcomes.

This study will evaluate the effectiveness of a structured nursing intervention that integrates sleep hygiene education with cognitive-behavioral strategies for improving sleep quality among patients with chronic heart failure. The intervention will be delivered by trained nurses through structured educational sessions and individualized counseling.

The sleep hygiene component includes education on maintaining a regular sleep schedule, optimizing the sleep environment, limiting caffeine and stimulating activities before bedtime, promoting physical activity appropriate to the patient's condition, and establishing healthy bedtime routines. The cognitive-behavioral component includes relaxation techniques, cognitive restructuring of maladaptive beliefs about sleep, stimulus control, and behavioral strategies to reduce sleep-related anxiety.

Participants will be assessed at baseline before the intervention and at predetermined follow-up intervals after completion of the program. The primary outcome is sleep quality measured using a validated sleep assessment instrument. Secondary outcomes may include fatigue, quality of life, daytime functioning, and adherence to recommended sleep practices. The findings of this study are expected to support the integration of evidence-based nursing interventions into routine care for patients with chronic heart failure to improve sleep and overall well-being.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

盲法说明

Outcome assessors will be blinded to participants' group allocation to minimize assessment bias. Participants and the nurses delivering the intervention cannot be blinded because of the nature of the educational and behavioral intervention.

入排标准

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

入选标准

  • Adult patients aged 18 to 65 years.
  • Diagnosed with chronic heart failure for at least 6 months according to the New York Heart Association (NYHA) classification.
  • Experiencing poor sleep quality as indicated by a score >5 on the Pittsburgh Sleep Quality Index during the previous month.

排除标准

  • Patients with diagnosed psychiatric disorders or severe cognitive impairment.
  • Patients receiving sedative-hypnotic therapy initiated within the previous month.
  • Patients diagnosed with obstructive sleep apnea requiring continuous positive airway pressure therapy.
  • Patients participating in other behavioral intervention program

研究组 & 干预措施

Structured Nursing Intervention

Experimental

Participants receive the structured nursing intervention incorporating sleep hygiene education and cognitive-behavioral strategies in addition to usual care.

干预措施: Structured Nursing Intervention Incorporating Sleep Hygiene and Cognitive-Behavioral Strategies (Behavioral)

Routine Care

No Intervention

Participants assigned to the control arm will receive the standard care routinely provided for patients with chronic heart failure, including routine medical management, nursing care, and follow-up according to hospital practice. They will not receive the structured nursing intervention incorporating sleep hygiene education and cognitive-behavioral strategies.

结局指标

主要结局

Sleep Quality

时间窗: Baseline and 3 months after completion of the intervention.

Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a validated self-reported questionnaire that measures subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Higher global PSQI scores indicate poorer sleep quality.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eman Abdelfatah Shokr

Dr

Al-Zaytoonah University of Jordan

研究点 (1)

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