Heart FailureNCT07752706
Breathing Exercises for Dyspnea and Anxiety in Heart Failure
A study testing Diaphragmatic and Pursed-Lip Breathing Exercises in people with Heart Failure and Breathing Exercises, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Heart failure is a leading cause of emergency department admissions, with dyspnea and psychological distress being among the most common presenting symptoms. This randomized controlled trial aims to evaluate the effect of nurse-guided diaphragmatic breathing and pursed-lip breathing exercises on dyspnea and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Breathing Exercises, Dyspnea
- What is being tested?
- Diaphragmatic and Pursed-Lip Breathing Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Mar 2025to 5 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Applicants must be 18 years of age or older. Volunteer to participate in the study. Present to the emergency department of the hospital where the study is planned to be conducted.
- Having been diagnosed with NYHA stage III-IV heart failure by a physician. Being able to understand and speak Turkish.
Who cannot join
- Being under 18 years of age Not being a volunteer to participate in the study Using narcotic analgesics to a degree that affects understanding questions and communication, Having a diagnosis of serious mental illness Not having been diagnosed with NYHA stage III-IV heart failure by a physician
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Breathing Exercises on Dyspnea and Anxiety in Patients Presenting to the Emergency Department Due to Heart Failure
Heart failure is a leading cause of emergency department admissions, with dyspnea and psychological distress being among the most common presenting symptoms. This randomized controlled trial aims to evaluate the effect of nurse-guided diaphragmatic breathing and pursed-lip breathing exercises on dyspnea and psychological distress in patients presenting to the emergency department with heart failure. A total of 112 eligible participants will be randomly assigned in a 1:1 ratio to either an intervention group receiving breathing exercises in addition to standard care or a control group receiving standard care alone. Dyspnea severity will be assessed using the Modified Borg Dyspnea Scale, and psychological distress will be assessed using the Distress Thermometer at predefined time points. The findings are expected to provide evidence for the effectiveness of a simple, low-cost, nurse-led non-pharmacological intervention in improving symptom management in patients with heart failure.
Read the detailed description
Heart failure is a major public health problem associated with frequent emergency department admissions due to symptoms such as dyspnea and anxiety. Dyspnea is one of the most distressing symptoms experienced by patients with heart failure and is often accompanied by increased anxiety, which may further worsen respiratory distress. Although pharmacological treatment remains the cornerstone of acute management, non-pharmacological interventions, including breathing exercises, may provide additional symptom relief.
The aim of this randomized controlled trial is to evaluate the effect of diaphragmatic breathing and pursed-lip breathing exercises on dyspnea and anxiety in patients presenting to the emergency department with heart failure.
A total of 112 eligible patients will be randomly assigned to either an intervention group or a control group. Participants in the intervention group will receive standard emergency department care in addition to nurse-guided diaphragmatic breathing and pursed-lip breathing exercises. The control group will receive standard emergency department care alone.
Clinical parameters, including pulse rate, blood pressure, respiratory rate, oxygen saturation, and distress level, will be assessed according to the study protocol. Dyspnea severity will be evaluated using the Modified Borg Dyspnea Scale, and anxiety-related distress will be assessed using the Distress Thermometer. Outcome measurements will be obtained at baseline and at predefined time points following the intervention.
The primary objective is to determine whether breathing exercises reduce dyspnea severity and anxiety compared with standard care. The findings of this study are expected to provide evidence regarding the effectiveness of a simple, low-cost, and nurse-led non-pharmacological intervention that may improve symptom management in patients with heart failure treated in emergency departments.
- Conditions
- Heart Failure, Breathing Exercises, Dyspnea, Anxiety
- Being tested
- Diaphragmatic and Pursed-Lip Breathing Exercises
- Medical subject headings
- Heart Failure, Dyspnea, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic and Pursed-Lip Breathing ExercisesOther
Participants received standard emergency department care plus nurse-guided diaphragmatic breathing and pursed-lip breathing exercises. The intervention consisted of three cycles of breathing exercises with rest periods between cycles. Participants were observed and supported throughout the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No Intervention |
| Experimental | Experimental | Behavioral: Diaphragmatic and Pursed-Lip Breathing Exercises Receives: Other: Diaphragmatic and Pursed-Lip Breathing Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in psychological distress measured by the Distress Thermometer
Psychological distress will be assessed using the Distress Thermometer
Measured: Baseline (before intervention), and at 5, 10, 15, 30, 45, and 60 minutes after initiation of the intervention.
Change in dyspnea severity measured by the Modified Borg Dyspnea Scale
Dyspnea severity will be assessed using the Modified Borg Dyspnea Scale
Measured: Baseline (before intervention), and at 5, 10, 15, 30, 45, and 60 minutes after initiation of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start5 Mar 2025
- Primary completion5 Dec 2026 (estimated)
- Study completion5 Dec 2026 (estimated)
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.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Ağca, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752706
- Sponsor's protocol ID
- E-74555795-050.04-1248939
- Status last verified
- Mar 2026
- First submitted
- 11 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be available upon reasonable request from the corresponding author after publication of the study. Data will be shared in anonymized form.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breathing Exercises on Dyspnea and Anxiety in Patients Presenting to the Emergency Department Due to Heart Failure
- ClinicalTrials.gov ID
- NCT07752706
- Acronym / sponsor ID
- E-74555795-050.04-1248939
- Conditions
- Heart Failure, Breathing Exercises, Dyspnea, Anxiety
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- 5 Dec 2026 (estimated)
- Study completion
- 5 Dec 2026 (estimated)
- First posted
- 7 Aug 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.
Heart failure is a leading cause of emergency department admissions, with dyspnea and psychological distress being among the most common presenting symptoms. This randomized controlled trial aims to evaluate the effect of nurse-guided diaphragmatic breathing and pursed-lip breathing exercises on dyspnea and psychological distress in patients presenting to the emergency department with heart failure. A total of 112 eligible participants will be randomly assigned in a 1:1 ratio to either an intervention group receiving breathing exercises in addition to standard care or a control group receiving standard care alone. Dyspnea severity will be assessed using the Modified Borg Dyspnea Scale, and psychological distress will be assessed using the Distress Thermometer at predefined time points. The findings are expected to provide evidence for the effectiveness of a simple, low-cost, nurse-led non-pharmacological intervention in improving symptom management in patients with heart failure.
Detailed description
Heart failure is a major public health problem associated with frequent emergency department admissions due to symptoms such as dyspnea and anxiety. Dyspnea is one of the most distressing symptoms experienced by patients with heart failure and is often accompanied by increased anxiety, which may further worsen respiratory distress. Although pharmacological treatment remains the cornerstone of acute management, non-pharmacological interventions, including breathing exercises, may provide additional symptom relief.
The aim of this randomized controlled trial is to evaluate the effect of diaphragmatic breathing and pursed-lip breathing exercises on dyspnea and anxiety in patients presenting to the emergency department with heart failure.
A total of 112 eligible patients will be randomly assigned to either an intervention group or a control group. Participants in the intervention group will receive standard emergency department care in addition to nurse-guided diaphragmatic breathing and pursed-lip breathing exercises. The control group will receive standard emergency department care alone.
Clinical parameters, including pulse rate, blood pressure, respiratory rate, oxygen saturation, and distress level, will be assessed according to the study protocol. Dyspnea severity will be evaluated using the Modified Borg Dyspnea Scale, and anxiety-related distress will be assessed using the Distress Thermometer. Outcome measurements will be obtained at baseline and at predefined time points following the intervention.
The primary objective is to determine whether breathing exercises reduce dyspnea severity and anxiety compared with standard care. The findings of this study are expected to provide evidence regarding the effectiveness of a simple, low-cost, and nurse-led non-pharmacological intervention that may improve symptom management in patients with heart failure treated in emergency departments.
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 | No intervention | –No Intervention |
| Experimental | Experimental | Other: Diaphragmatic and Pursed-Lip Breathing ExercisesBehavioral: Diaphragmatic and Pursed-Lip Breathing Exercises |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Applicants must be 18 years of age or older. Volunteer to participate in the study. Present to the emergency department of the hospital where the study is planned to be conducted.
- Having been diagnosed with NYHA stage III-IV heart failure by a physician. Being able to understand and speak Turkish.
Key exclusion criteria (2 listed)
- Being under 18 years of age Not being a volunteer to participate in the study Using narcotic analgesics to a degree that affects understanding questions and communication, Having a diagnosis of serious mental illness Not having been diagnosed with NYHA stage III-IV heart failure by a physician
- -
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 |
|---|---|---|
| Diaphragmatic and Pursed-Lip Breathing ExercisesParticipants received standard emergency department care plus nurse-guided diaphragmatic breathing and pursed-lip breathing exercises. The intervention consisted of three cycles of breathing exercises with rest periods between cycles. Participants were observed and supported throughout the intervention. | Other | Experimental |
Primary outcome
Change in psychological distress measured by the Distress Thermometer
Time frame: Baseline (before intervention), and at 5, 10, 15, 30, 45, and 60 minutes after initiation of the intervention.
Psychological distress will be assessed using the Distress Thermometer
Change in dyspnea severity measured by the Modified Borg Dyspnea Scale
Time frame: Baseline (before intervention), and at 5, 10, 15, 30, 45, and 60 minutes after initiation of the intervention.
Dyspnea severity will be assessed using the Modified Borg Dyspnea Scale
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: Yes. Individual participant data will be available upon reasonable request from the corresponding author after publication of the study. Data will be shared in anonymized form.
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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 Diaphragmatic and Pursed-Lip Breathing Exercises in people with Heart Failure and Breathing Exercises, run by Istanbul University - Cerrahpasa 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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 7 Aug 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in psychological distress measured by the Distress Thermometer (time frame: Baseline (before intervention), and at 5, 10, 15, 30, 45, and 60 minutes after initiation of the intervention.). The study lists 2 primary outcomes in all. 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 7 Aug 2026.