The Effect of Sleep Hygiene Education on Disease Management and Sleep Quality in Individuals With Cardiovascular Diseases: A Randomized Controlled Clinical Trial Protocol
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Improvement in Sleep Quality
研究概览
简要总结
This clinical trial aims to find out if sleep hygiene education helps people with cardiovascular disease manage their illness better and improve their sleep quality.
Participants will be randomly assigned to two groups. One group will receive sleep hygiene education through a 30-minute presentation and twice-daily reminder messages for four weeks. The other group will receive usual care without education.
Before and after the four-week period, all participants will complete questionnaires about their sleep habits, sleep quality, and disease management.
The study hopes to show that sleep hygiene education can improve participants' sleep and help them manage their disease symptoms better, leading to a better quality of life.
The trial will take place at Near East University Hospital's Cardiology Department from June to December 2025.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Clinical diagnosis of cardiovascular disease at least one year prior
- •No visual, hearing, communication, cognitive, or physical impairments
- •Literate and able to use a smartphone and/or computer
- •Willing to participate in the sleep hygiene education program
- •Able to provide informed consent
排除标准
- •Pregnancy
- •Working night shifts
- •Cognitive impairment preventing questionnaire completion
- •Visual, hearing, communication, or physical impairments that prevent participation
研究组 & 干预措施
Intervention Group
干预措施: Sleep Hygiene Education (Behavioral)
Control
结局指标
主要结局
Improvement in Sleep Quality
时间窗: 5 weeks (4 weeks intervention + final assessment in week 5)
This outcome measures the change in participants' sleep quality after the 4-week sleep hygiene education program. Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI total score ranges from 0 to 21, where higher scores indicate worse sleep quality and lower scores indicate better sleep quality. Data will be collected at baseline and after completion of the intervention.
次要结局
- Improvement in Disease Management(5 weeks (4 weeks intervention + final assessment in week 5))
研究者
Deniz Talaz
Dr. Deniz Talaz, PhD, Principal Investigator, Department of Medical Nursing, Near East University
Near East University, Turkey