Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)NCT07232368
The Effect of Slow-Paced Breathing on Patient Outcomes in Pulmonary Arterial Hypertension
A study testing Slow-paced breathing intervention in people with Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH), run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the effects of slow-paced breathing (SPB) intervention applied to patients with pulmonary arterial hypertension (PAH) in the home environment on symptom management (dyspnea, fatigue, sleep quality), clinical parameters (Six-Minute Walking Test-6MWT), IL-6, NT-proBNP results) and quality… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)
- What is being tested?
- Slow-paced breathing intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Jun 2023to 15 Mar 2025
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between 18 and 65 years of age
- Being diagnosed with PAH (pulmonary arterial hypertension)- (Group I pulmonary hypertension (idiopathic, hereditary, drug or toxin-induced, or associated with connective tissue disease, congenital heart disease, or HIV-associated)) diagnosed by right heart catheterization
- Being on stable PAH treatment for the past three months and in a stable clinical condition (no changes in PAH medical treatment, no new medications added)
- Being in class II or III according to the World Health Organization functional classification
- Being able to speak Turkish
- Having a high level of technical digital literacy (obtaining the highest score (30 points) on the "technical subscale" of the Digital Literacy Scale*)
- Agreeing to participate in the study
Who cannot join
- Communication difficulties
- Symptomatic hypotension
- Pregnancy status for female participants (positive urine pregnancy test*)
- Presence of another underlying condition that may cause dyspnea, fatigue, and sleep difficulties (chronic fatigue syndrome, obstructive sleep apnea, restless legs syndrome, narcolepsy, major depression, etc.)
- Hospitalization or acute phase
- Active participation in a cardiac rehabilitation program
Show all 11Show fewer
- Presence of pulmonary hypertension due to left heart disease and pulmonary hypertension due to lung diseases and/or hypoxia
- Receiving a lung transplant
- Having had cardiac surgery within the last six months
- Presence of obesity
- Presence of mental retardation
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to investigate the effects of slow-paced breathing (SPB) intervention applied to patients with pulmonary arterial hypertension (PAH) in the home environment on symptom management (dyspnea, fatigue, sleep quality), clinical parameters (Six-Minute Walking Test-6MWT), IL-6, NT-proBNP results) and quality of life.
Read the detailed description
The therapeutic power of slow, controlled breathing has been recognized for centuries and is primarily used in relaxation techniques such as meditation and yoga.
It can be difficult for a patient to effectively perform these exercises on their own without training or individualized coaching.
Numerous studies in recent years have shown that therapeutic breathing exercises performed without conscious effort, using devices, have positive effects on parameters such as blood pressure, stress management, respiratory modulation, sleep difficulties, and quality of life.
Furthermore, the effects of slow-paced breathing performed with conscious effort using visual and auditory triggers have also been demonstrated in many studies.
Slow-paced breathing is a breathing technique that aims to slow the inhalation and exhalation phases to a controlled rate determined by a visual, auditory, or kinesthetic pacer.
While the spontaneous respiratory rate in adults is generally between 12 and 20 breaths per minute, this rate is reduced to as little as 6 breaths per minute with slow-paced breathing.
With the therapeutic use of slow-paced breathing intervention, Studies have shown that arterial baroreflex sensitivity is increased, cardiopulmonary reflexes are activated, vascular resistance is reduced, peripheral blood flow is increased, and many positive effects on the cardiovascular system and respiratory functions, including respiratory sinus arrhythmia and exercise tolerance.
There are very few studies on the outcomes of interventions aimed at symptom control, one of the most important goals of nursing care in pulmonary arterial hypertension.
The existing studies (only two) are foreign-based and uncontrolled experimental studies. While they demonstrate the positive effects of the interventions, they cannot provide comprehensive data and have limited evidence. Further studies are needed to provide sufficient evidence on the subject. Furthermore, a systematic review of the existing literature revealed that studies on PAH, a rare disease, are quite limited at all levels. The nursing literature is even more limited.
A video of a slow-paced breathing practice was used as an educational material in our research.
This video was prepared with expert support based on videos used in similar studies for educational and demonstration purposes.
The video preparation process: The presentation began with the preparation of a PowerPoint presentation using Microsoft Office 365 on a computer. The PowerPoint program's video conversion feature was used to make the presentation accessible on all platforms (Windows, iOS, Android, etc.).
The video included a visual guide (a moving ball) that was followed visually to ensure adherence to a predetermined breathing rate, accompanied by relaxing music. This visual guide asked patients to continuously inhale through the nose as the ball rose, and to continuously exhale through the mouth with pursed lips as the ball descended.
This study, which investigates the effects of slow-paced breathing intervention applied at home in patients with pulmonary arterial hypertension on symptom management, clinical parameters, and quality of life, is a study that will contribute to the literature on cardiology nursing in our country and around the world.
- Being tested
- Slow-paced breathing intervention
- Keywords
- Pulmonary Arterial Hypertension, Slow-paced Breathing, Symptom Management, Quality of life, Nursing
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slow-paced breathing interventionOther
Other: Slow-paced breathing intervention After the intervention and control groups were determined, the purpose of the study was explained to both groups. Participants were informed that the intervention would last 12 weeks. Data collection forms would be completed face-to-face before the intervention (initial follow-up), during the 6th week (interim follow-up), and at the 12th week (final follow-up).
Patients in the intervention group received a slow-paced breathing intervention in addition to the standard treatment protocol (verbal, video, and hands-on instruction, demonstration). After the first interview, participants received the application video (installed on a device such as a mobile phone, personal computer, and/or tablet, depending on the participant's preference and ease of use).
The control group received only the standard treatment protocol. However, they were informed that they could perform the slow-paced breathing intervention upon completion of the study if they wished
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Data collection tools were applied to individuals in the control group at week 0 (first follow-up), week 6 (interim follow-up) and week 12 (final follow-up) of the follow-up period. The data collection tools administered to the control group were: Patient Identification Form, Multidimensional Dyspnea Profile, Multidimensional Fatigue Inventory, Pittsburgh Sleep Quality Index, Six-Minute Walk Test Form and Modified Borg Scale, Laboratory Analysis Form, and EmPHasis-10 Quality of Life Scale, Digital Literacy Scale-Technical Subscale. |
| initiative group | Experimental | Data collection tools were administered to individuals in the intervention group at week 0 (initial follow-up), week 6 (interim follow-up), and week 12 (final follow-up).
Data collection tools administered to the intervention group included:
Patient Identification Form, Multidimensional Dyspnea Profile, Multidimensional Fatigue Inventory, Pitsburgh Sleep Quality Index, Six-Minute Walk Test Form and Modified Borg Scale, Laboratory Analysis Form, EmPHasis-10 Quality of Life Scale, Digital Literacy Scale-Technical Subscale. Receives: Other: Slow-paced breathing intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multidimensional Dyspnea Profile
The multidimensional dyspnea profile consists of subheadings assessing immediate perception (6 items; total score range 0-60) and emotional reactions (5 items; total score range 0-50). Items are rated on a 0-10 scale, with higher scores indicating greater intensity, unpleasantness, or distress.
Measured: Baseline, at the end of six weeks and at the end of twelve weeks
Multidimensional Fatigue Inventory
The inventory contains five subscales measuring general fatigue (items 1, 5, 12, and 16), physical fatigue (items 2, 8, 14, and 20), decreased activity (items 3, 6, 10, and 17), decreased motivation (items 4, 9, 15, and 18), and mental fatigue (items 7, 11, 13, and 19), totaling 20 items.
Measured: Baseline, at the end of six weeks and at the end of twelve weeks
Pittsburgh Sleep Quality Index
The index is a self-report measure that provides a quantitative measure of sleep quality to describe good and poor sleep over a one-month period. It consists of seven subcomponents and 24 items, 19 of which are self-reported and five of which are self-reported or evaluated by a roommate, if present.
Measured: Baseline, at the end of six weeks and at the end of twelve weeks
Six-Minute Walk Test Form and Modified Borg Scale
The 6MWT (Six-Minute Walk Test), the most commonly used exercise test in monitoring patients with pulmonary hypertension, is an easy-to-administer and inexpensive test. Walking speed should be determined by the patient, but the goal of the test is to walk as far as possible in six minutes.
The Modified Borg Scale, a unidimensional scale, is a subjective, reliable, and easily administered tool for determining the severity of dyspnea and fatigue perceived by the patient at rest and during exertion. The scale identifies the severity of dyspnea/fatigue by rating (0 to 10), with a score of 0 indicating "absent" and a score of 10 indicating "maximum" dyspnea/fatigue.
Measured: Baseline, and at the end of twelve weeks
Laboratory Analysis Form
It is recommended to monitor certain variables (NT-proBNP) at regular intervals during the diagnosis and follow-up phases of the disease. These variables can be used to assess prognosis and risk stratify, while also guiding the treatment protocol.
In addition, some studies have used IL-6 as an indicator of inflammation and correlated it with sleep quality.
Measured: Baseline, and at the end of twelve weeks
EmPHasis-10 Quality of Life Scale
This 10-question scale, developed for patients with pulmonary hypertension, addresses concerns about the disease's significant effects, such as shortness of breath, fatigue, and lack of energy, as well as its impact on social relationships. Each question on the scale has a score between 0 and 5 and is assessed using a Likert scale.
Measured: Baseline, at the end of six weeks and at the end of twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start11 Jun 2023
- Primary completion15 Sep 2023
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)Studies of the same condition, open and under way.
- More trials run by Ege UniversityThe 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
- Model description
- It consists of two groups, application and control
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fikriye Ersel, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07232368
- Sponsor's protocol ID
- 22-AKD-202
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Slow-Paced Breathing on Patient Outcomes in Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT07232368
- Acronym / sponsor ID
- 22-AKD-202
- Keywords
- Pulmonary Arterial Hypertension, Slow-paced Breathing, Symptom Management, Quality of life, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 11 Jun 2023 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 18 Nov 2025 (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.
This study aims to investigate the effects of slow-paced breathing (SPB) intervention applied to patients with pulmonary arterial hypertension (PAH) in the home environment on symptom management (dyspnea, fatigue, sleep quality), clinical parameters (Six-Minute Walking Test-6MWT), IL-6, NT-proBNP results) and quality of life.
Detailed description
The therapeutic power of slow, controlled breathing has been recognized for centuries and is primarily used in relaxation techniques such as meditation and yoga.
It can be difficult for a patient to effectively perform these exercises on their own without training or individualized coaching.
Numerous studies in recent years have shown that therapeutic breathing exercises performed without conscious effort, using devices, have positive effects on parameters such as blood pressure, stress management, respiratory modulation, sleep difficulties, and quality of life.
Furthermore, the effects of slow-paced breathing performed with conscious effort using visual and auditory triggers have also been demonstrated in many studies.
Slow-paced breathing is a breathing technique that aims to slow the inhalation and exhalation phases to a controlled rate determined by a visual, auditory, or kinesthetic pacer.
While the spontaneous respiratory rate in adults is generally between 12 and 20 breaths per minute, this rate is reduced to as little as 6 breaths per minute with slow-paced breathing.
With the therapeutic use of slow-paced breathing intervention, Studies have shown that arterial baroreflex sensitivity is increased, cardiopulmonary reflexes are activated, vascular resistance is reduced, peripheral blood flow is increased, and many positive effects on the cardiovascular system and respiratory functions, including respiratory sinus arrhythmia and exercise tolerance.
There are very few studies on the outcomes of interventions aimed at symptom control, one of the most important goals of nursing care in pulmonary arterial hypertension.
The existing studies (only two) are foreign-based and uncontrolled experimental studies. While they demonstrate the positive effects of the interventions, they cannot provide comprehensive data and have limited evidence. Further studies are needed to provide sufficient evidence on the subject. Furthermore, a systematic review of the existing literature revealed that studies on PAH, a rare disease, are quite limited at all levels. The nursing literature is even more limited.
A video of a slow-paced breathing practice was used as an educational material in our research.
This video was prepared with expert support based on videos used in similar studies for educational and demonstration purposes.
The video preparation process: The presentation began with the preparation of a PowerPoint presentation using Microsoft Office 365 on a computer. The PowerPoint program's video conversion feature was used to make the presentation accessible on all platforms (Windows, iOS, Android, etc.).
The video included a visual guide (a moving ball) that was followed visually to ensure adherence to a predetermined breathing rate, accompanied by relaxing music. This visual guide asked patients to continuously inhale through the nose as the ball rose, and to continuously exhale through the mouth with pursed lips as the ball descended.
This study, which investigates the effects of slow-paced breathing intervention applied at home in patients with pulmonary arterial hypertension on symptom management, clinical parameters, and quality of life, is a study that will contribute to the literature on cardiology nursing in our country and around the world.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- It consists of two groups, application and control
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Data collection tools were applied to individuals in the control group at week 0 (first follow-up), week 6 (interim follow-up) and week 12 (final follow-up) of the follow-up period. The data collection tools administered to the control group were: Patient Identification Form, Multidimensional Dyspnea Profile, Multidimensional Fatigue Inventory, Pittsburgh Sleep Quality Index, Six-Minute Walk Test Form and Modified Borg Scale, Laboratory Analysis Form, and EmPHasis-10 Quality of Life Scale, Digital Literacy Scale-Technical Subscale. |
| initiative group | Experimental | Other: Slow-paced breathing interventionData collection tools were administered to individuals in the intervention group at week 0 (initial follow-up), week 6 (interim follow-up), and week 12 (final follow-up). Data collection tools administered to the intervention group included: Patient Identification Form, Multidimensional Dyspnea Profile, Multidimensional Fatigue Inventory, Pitsburgh Sleep Quality Index, Six-Minute Walk Test Form and Modified Borg Scale, Laboratory Analysis Form, EmPHasis-10 Quality of Life Scale, Digital Literacy Scale-Technical Subscale. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Being between 18 and 65 years of age
- Being diagnosed with PAH (pulmonary arterial hypertension)- (Group I pulmonary hypertension (idiopathic, hereditary, drug or toxin-induced, or associated with connective tissue disease, congenital heart disease, or HIV-associated)) diagnosed by right heart catheterization
- Being on stable PAH treatment for the past three months and in a stable clinical condition (no changes in PAH medical treatment, no new medications added)
- Being in class II or III according to the World Health Organization functional classification
- Being able to speak Turkish
Key exclusion criteria (11 listed)
- Communication difficulties
- Symptomatic hypotension
- Pregnancy status for female participants (positive urine pregnancy test*)
- Presence of another underlying condition that may cause dyspnea, fatigue, and sleep difficulties (chronic fatigue syndrome, obstructive sleep apnea, restless legs syndrome, narcolepsy, major depression, etc.)
- Hospitalization or acute phase
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 |
|---|---|---|
| Slow-paced breathing interventionOther: Slow-paced breathing intervention After the intervention and control groups were determined, the purpose of the study was explained to both groups. Participants were informed that the intervention would last 12 weeks. Data collection forms would be completed face-to-face before the intervention (initial follow-up), during the 6th week (interim follow-up), and at the 12th week (final follow-up). Patients in the intervention group received a slow-paced breathing intervention in addition to the standard treatment protocol (verbal, video, and hands-on instruction, demonstration). After the first interview, participants received the application video (installed on a device such as a mobile phone, personal computer, and/or tablet, depending on the participant's preference and ease of use). The control group received only the standard treatment protocol. However, they were informed that they could perform the slow-paced breathing intervention upon completion of the study if they wished | Other | initiative group |
Primary outcome
Multidimensional Dyspnea Profile
Time frame: Baseline, at the end of six weeks and at the end of twelve weeks
The multidimensional dyspnea profile consists of subheadings assessing immediate perception (6 items; total score range 0-60) and emotional reactions (5 items; total score range 0-50). Items are rated on a 0-10 scale, with higher scores indicating greater intensity, unpleasantness, or distress.
Multidimensional Fatigue Inventory
Time frame: Baseline, at the end of six weeks and at the end of twelve weeks
The inventory contains five subscales measuring general fatigue (items 1, 5, 12, and 16), physical fatigue (items 2, 8, 14, and 20), decreased activity (items 3, 6, 10, and 17), decreased motivation (items 4, 9, 15, and 18), and mental fatigue (items 7, 11, 13, and 19), totaling 20 items.
Pittsburgh Sleep Quality Index
Time frame: Baseline, at the end of six weeks and at the end of twelve weeks
The index is a self-report measure that provides a quantitative measure of sleep quality to describe good and poor sleep over a one-month period. It consists of seven subcomponents and 24 items, 19 of which are self-reported and five of which are self-reported or evaluated by a roommate, if present.
Six-Minute Walk Test Form and Modified Borg Scale
Time frame: Baseline, and at the end of twelve weeks
The 6MWT (Six-Minute Walk Test), the most commonly used exercise test in monitoring patients with pulmonary hypertension, is an easy-to-administer and inexpensive test. Walking speed should be determined by the patient, but the goal of the test is to walk as far as possible in six minutes. The Modified Borg Scale, a unidimensional scale, is a subjective, reliable, and easily administered tool for determining the severity of dyspnea and fatigue perceived by the patient at rest and during exertion. The scale identifies the severity of dyspnea/fatigue by rating (0 to 10), with a score of 0 indicating "absent" and a score of 10 indicating "maximum" dyspnea/fatigue.
Laboratory Analysis Form
Time frame: Baseline, and at the end of twelve weeks
It is recommended to monitor certain variables (NT-proBNP) at regular intervals during the diagnosis and follow-up phases of the disease. These variables can be used to assess prognosis and risk stratify, while also guiding the treatment protocol. In addition, some studies have used IL-6 as an indicator of inflammation and correlated it with sleep quality.
EmPHasis-10 Quality of Life Scale
Time frame: Baseline, at the end of six weeks and at the end of twelve weeks
This 10-question scale, developed for patients with pulmonary hypertension, addresses concerns about the disease's significant effects, such as shortness of breath, fatigue, and lack of energy, as well as its impact on social relationships. Each question on the scale has a score between 0 and 5 and is assessed using a Likert scale.
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 18 Nov 2025.
- 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 Slow-paced breathing intervention in people with Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH), run by Ege 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 7 inclusion and 11 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 18 Nov 2025. 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?
Multidimensional Dyspnea Profile (time frame: Baseline, at the end of six weeks and at the end of twelve weeks). The study lists 6 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 18 Nov 2025.