Skip to main content
OpenTrials
Completed

NCT Number: NCT07824687

Effect of Mindful Breathing in Patient With Heart Failure:

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases Mindful Breathing Meditation Nursing Care Symptom Management

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Health Sciences University

Ankara, Keçiören, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mindful Breathing

Other

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.

Primary outcomes

  1. Primary outcome measures

    Time frame: 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 outcomes

  1. Change in Left Ventricular Ejection Fraction

    Time frame: Baseline and Week 8

    Ejection fraction (%) obtained from the hospital data system via echocardiography.

  2. Change in High-Density Lipoprotein (HDL) Cholesterol

    Time frame: Baseline, Week 8, and Week 12

    HDL cholesterol level (mg/dL) measured from peripheral venous blood samples.

  3. Change in Total Cholesterol

    Time frame: Baseline, Week 8, and Week 12

    Total cholesterol level (mg/dL) measured from peripheral venous blood samples.

  4. Change in Triglycerides

    Time frame: Baseline, Week 8, and Week 12

    Triglyceride level (mg/dL) measured from peripheral venous blood samples.

Sponsors and collaborators

Lead sponsor

Ankara Medipol University

Other

Registry information

Official study title

Effect of Mindful Breathing on Symptom Status and Clinical Parameters in Patient With Heart Failure : A Randomized Controlled Trail

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.