Heart Failure, Mindful Breathing Meditation, Nursing Care, Symptom Management
Conditions
Keywords
heart failure, nursing care, symtpom management, mindful breathing, meditation
Brief summary
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.
Detailed description
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.
Interventions
OTHERMindful Breathing
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.
Sponsors
Ankara Medipol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary outcome measures | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Left Ventricular Ejection Fraction | Baseline and Week 8 | Ejection fraction (%) obtained from the hospital data system via echocardiography. |
| Change in High-Density Lipoprotein (HDL) Cholesterol | Baseline, Week 8, and Week 12 | HDL cholesterol level (mg/dL) measured from peripheral venous blood samples. |
| Change in Total Cholesterol | Baseline, Week 8, and Week 12 | Total cholesterol level (mg/dL) measured from peripheral venous blood samples. |
| Change in Triglycerides | Baseline, Week 8, and Week 12 | Triglyceride level (mg/dL) measured from peripheral venous blood samples. |
Countries
Turkey (Türkiye)
Outcome results
None listed