Heart FailureNCT07824687
Effect of Mindful Breathing in Patient With Heart Failure:
A study testing Mindful Breathing in people with Heart Failure and Nursing Care, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Nursing Care, Symptom Management
- What is being tested?
- Mindful Breathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2023to 15 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Health Sciences University
Ankara, Keçiören
About this study
Official title: Effect of Mindful Breathing on Symptom Status and Clinical Parameters in Patient With Heart Failure : A Randomized Controlled Trail
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.
Read the 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.
- Being tested
- Mindful Breathing
- Keywords
- heart failure, nursing care, symtpom management, mindful breathing, meditation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful BreathingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | 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 | Experimental | The experimental group received 20 min mindful breathing training according to Kabat - Zinn mindful meditation. Receives: Other: Mindful Breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 8, and Week 12
Secondary outcomes (4)
Change in Left Ventricular Ejection Fraction
Ejection fraction (%) obtained from the hospital data system via echocardiography.
Measured: Baseline and Week 8
Change in High-Density Lipoprotein (HDL) Cholesterol
HDL cholesterol level (mg/dL) measured from peripheral venous blood samples.
Measured: Baseline, Week 8, and Week 12
Change in Total Cholesterol
Total cholesterol level (mg/dL) measured from peripheral venous blood samples.
Measured: Baseline, Week 8, and Week 12
Change in Triglycerides
Triglyceride level (mg/dL) measured from peripheral venous blood samples.
Measured: Baseline, Week 8, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start10 Oct 2023
- Primary completion10 Apr 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve ÇAKICI, Ankara Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824687
- Sponsor's protocol ID
- 14082023
- Status last verified
- Jul 2026
- First submitted
- 9 Feb 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mindful Breathing on Symptom Status and Clinical Parameters in Patient With Heart Failure : A Randomized Controlled Trail
- ClinicalTrials.gov ID
- NCT07824687
- Acronym / sponsor ID
- 14082023
- Keywords
- heart failure, nursing care, symtpom management, mindful breathing, meditation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Ankara Medipol UniversityUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 10 Apr 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –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 | Experimental | Other: Mindful BreathingThe experimental group received 20 min mindful breathing training according to Kabat - Zinn mindful meditation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindful BreathingThe 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. | Other | experimental group |
Primary outcome
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.
4 secondary outcomes
Change in Left Ventricular Ejection Fraction
Time frame: Baseline and Week 8
Change in High-Density Lipoprotein (HDL) Cholesterol
Time frame: Baseline, Week 8, and Week 12
Change in Total Cholesterol
Time frame: Baseline, Week 8, and Week 12
Change in Triglycerides
Time frame: Baseline, Week 8, and Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Breathing in people with Heart Failure and Nursing Care, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome measures (time frame: Baseline, Week 8, and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.