Effect of Mindful Breathing on Symptom Status and Clinical Parameters in Patient With Heart Failure : A Randomized Controlled Trail
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Primary outcome measures
研究概览
简要总结
The aim of this study was to investigate the effect of mindful breathing on symptom status and clinical parameters in patients with heart failure. This randomized controlled trial was conducted with a total 64 patients who randomly allocated to receive 64 HF patients. Stratified block randomization was used for randomization according to New York Heart Association classification heart failure (NYHA Stage II -III). Patients in the intervention group (n=32) performed mindful breathing for 20 minutes daily for 8 weeks. The control group (n=32) received routine treatment. The Heart Failure Symptom Status Scale was administered face-to- face to both groups on 0th day, at 8th and 12th weeks. Routine clinic evaluations included low-density lipoprotein, high-density lipoprotein, total cholesterol, and triglyceride levels assessed on 0th day, at 8th and 12th weeks. Ejection fraction values were accessed from the hospital data system on 0th day at the 8th week. The data were analyzed using IBM SPSS V23 and JAMOVI software.
详细描述
This study was a single-site, parallel-group, randomized controlled trial.The study was carried out in a hospital located the Turkey between October 2023 and May 2024. 64 individuals with HF stages II and III.Participants were recruited through face-to-face contact at cardiology polyclinics. Researcher contacted all potentially eligible individuals referred by cardiology doctors to determine eligibility and interest for participation. Participants in intervention group were encouraged to daily 20 min mindful breathing practice along 8 weeks.In the control group received standard care alone.
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
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the research conducted, the researcher was involved in the implementation of the mindful breathing , data collection, and analysis phases; and the patients in the intervention group of the research were aware of the implementation, therefore, blinding of the researcher and participants could not be performed. The statistician who conducted the analysis phase of the research had no knowledge of the determined groups. In this way, selection bias, detection bias, and analysis bias were prevented.
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
- •Diagnosed with NYHA Stage II or III heart failure
- •Have experienced heart failure symptoms
- •Aged 18 years or older
- •Able to read and write in Turkish
- •Able to use a smartphone, respond to daily researcher calls, and participate in WhatsApp video conferences
排除标准
- •Diagnosed with NYHA Stage I or IV heart failure
- •Having physical or mental conditions that impair communication
- •Currently using non-pharmacological treatments such as herbal medicine, meditation, or yoga
- •Having health conditions that prevent breath awareness exercises (e.g., advanced asthma, advanced COPD)
研究组 & 干预措施
control group
In the control group received standard care alone. They received training about mindful breathing and accessed audio record via What's-App and mobile application end of the study.
experimental group
The experimental group received 20 min mindful breathing training according to Kabat - Zinn mindful meditation.
干预措施: Mindful Breathing (Other)
结局指标
主要结局
Primary outcome measures
时间窗: Baseline, Week 8, and Week 12
Change in Heart Failure Symptom Status Questionnaire (SSQ-HF) Score Description: The Symptom Status Questionnaire-Heart Failure (SSQ-HF) measures the frequency, severity, and distress of heart failure-related symptoms. Possible scores range from 0 to 84, with higher scores indicating greater symptom burden.
次要结局
- Change in Left Ventricular Ejection Fraction(Baseline and Week 8)
- Change in High-Density Lipoprotein (HDL) Cholesterol(Baseline, Week 8, and Week 12)
- Change in Total Cholesterol(Baseline, Week 8, and Week 12)
- Change in Triglycerides(Baseline, Week 8, and Week 12)
研究者
Merve ÇAKICI
Assistant professor
Ankara Medipol University