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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
64
The experimental group performed 20-min mindful breathing sessions once a day for 8 weeks. Prior to these sessions, participants were given a 1-hour training on the basics and benefits of mindfulness and mindful breathing. Participants received an audio recording developed by the Investigators.The audio was sent via WhatsApp to ensure consistent intervention delivery. Also Breathing in My Heart Mobile Application was developed by investigators. These audio instructions were recorded in Turkish.
Ankara Health Sciences University
Ankara, Keçiören, Turkey (Türkiye)
Primary outcome measures
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.
Time frame: Baseline, Week 8, and Week 12
Change in Left Ventricular Ejection Fraction
Ejection fraction (%) obtained from the hospital data system via echocardiography.
Time frame: Baseline and Week 8
Change in High-Density Lipoprotein (HDL) Cholesterol
HDL cholesterol level (mg/dL) measured from peripheral venous blood samples.
Time frame: Baseline, Week 8, and Week 12
Change in Total Cholesterol
Total cholesterol level (mg/dL) measured from peripheral venous blood samples.
Time frame: Baseline, Week 8, and Week 12
Change in Triglycerides
Triglyceride level (mg/dL) measured from peripheral venous blood samples.
Time frame: Baseline, Week 8, and Week 12
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