Slow BreathingNCT06098222
The Effect of Slow Breathing Exercise Applied to Patients on Pulse, Blood Pressure and Quality of Life
A study testing Slow breathing exercise training in people with Slow Breathing and Acute Myocardial Infarction, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study was designed as a randomized controlled experimental type in order to determine the effect of slow breathing exercise applied after the procedure on heart rate, blood pressure and quality of life in patients who underwent Primary Percutaneous Coronary Intervention (PCI) I after the diagnosis of ST Elevation… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Slow Breathing, Acute Myocardial Infarction
- What is being tested?
- Slow breathing exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Oct 2023to 1 Oct 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Young adult patients between the ages of 18-65,
- Patients who have not received fibrinolytic therapy before or simultaneously with Percutaneous Coronary Intervention (PCI) procedure,
- Patients who have passed 24 hours after the PCI procedure,
- Patients with a pulse > 60/min (whether or not beta blockers are used after PCI),
- Patients without rhythm problems,
- Patients with hypertension (systolic blood pressure 140-179 mmHg, diastolic blood pressure 90-109 mmHg), (whether or not they use antihypertensive and beta blocker drugs),
Show all 15Show fewer
- Patients without a diagnosis of mental or psychiatric disease,
- Patients who have the materials to watch the breathing exercise video,
- Patients who can receive reminder messages and make video calls (with devices such as a smartphone, computer, tablet, etc.),
- Patients with a portable blood pressure monitor suitable for pulse and blood pressure measurement during home monitoring (the necessary equipment will be provided within the scope of the TUBITAK project),
- Patients without hearing or visual impairment,
- Patients who can read and write
- Patients who can communicate,
- Patients without language problems,
- Patients who volunteer and indicate this verbally and in writing
Who cannot join
- Patients with elective/appointed appointments for whom PCI is planned in advance,
- Patients whose PCI procedure failed,
- Patients who underwent only thrombus aspiration and balloon angioplasty during the PCI procedure,
- Patients who have previously undergone PCI and at least one year has not passed since,
- Patients who do not comply with planned interventions,
- Patients who do not volunteer to participate in the study,
Show all 13Show fewer
- Patients with physical limitations and respiratory distress who cannot do breathing exercises,
- Patients with rhythm problems,
- Patients with diseases that can increase heart rate (anemia, hyperthyroidism, hyperthermia, infection),
- Patients who are morbidly obese (Body Mass Index > 40 kg/m2),
- Patients with hearing impairment,
- Patients with mental disabilities or perception problems,
- Patients who have previously received breathing therapy training will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Provincial Directorate of Health Koşuyolu High Specialization Education and Research Hospital
Istanbul, 34852
CELIK, MELIKE, +905321562205, celik.melike@live.com
About this study
Official title: The Effect of Slow Breathing Exercise Applied to Patients After Primary Percutaneous Coronary Intervention on Pulse, Blood Pressure and Quality of Life
This study was designed as a randomized controlled experimental type in order to determine the effect of slow breathing exercise applied after the procedure on heart rate, blood pressure and quality of life in patients who underwent Primary Percutaneous Coronary Intervention (PCI) I after the diagnosis of ST Elevation Myocardial Infarction (STEMI).
Patients who underwent primary PCI due to STEMI in a Training and Research Hospital in Istanbul will constitute the study population. A sample will be formed with a total of 80 patients, 40 experimental and 40 control groups, selected by computer assisted simple randomization method among volunteer patients who underwent primary PCI and met the inclusion criteria.
Read more
In this study, slow breathing exercise training will be given to the experimental group by the coordinator. In their home followmup after discharge, they will be asked to do slow breathing exercises for 10 minutes twice a day for eight weeks.
Data will be collected using the "Patient Information Form", "MacNew Heart Disease Health Related Quality of Life Scale", "VAS Breath Therapy Satisfaction Evaluation Form", "Self-Monitoring Form" and "Patient Follow up Form". Patients will be seen again during the outpatient clinic examination in the fourth and eighth weeks and the effectiveness of slow breathing exercises will be evaluated with data collection forms.
Read the detailed description
Cardiovascular Diseases (CVD) is still the leading cause of death in the world and in our country, despite significant advances in its diagnosis and treatment. Acute Coronary Syndromes (ACS), which are among the CVD's, occur with the deterioration of the integrity of the atherosclerotic plaque in the coronary vessels. The deadliest form of ACS is ST Elevation Myocardial Infarction (STEMI).
Primary Percutaneous Coronary Intervention (PCI) is recommended primarily in the treatment of acute myocardial infarction. In these patients, changes in vital signs resulting from diagnosis and treatment and a permanent effect on quality of life can be observed.
Slow breathing exercise is a behavioral technique in which a low breathing rate is applied. Breathing exercises reduce heart rate, blood pressure, reduce anxiety and pain while shown to improve symptoms and improve quality of life in patients with chronic obstructive pulmonary disease and asthma. This technique provides conscious deep and slow breathing and effective breathing, as well as improving conscious control over relaxation and increasing awareness.
This study was designed as a randomized controlled experimental type in order to determine the effect of slow breathing exercise applied after the procedure on heart rate, blood pressure and quality of life in patients who underwent PCI after the diagnosis of STEMI. Study data will be collected between 23 October 2023- 30 April 2024 Patients who underwent primary PCI due to STEMI in a Training and Research Hospital in Istanbul will constitute the study population. A sample will be formed with a total of 80 patients, 40 experimental and 40 control groups, selected by computer assisted simple randomization method among volunteer patients who underwent primary PCI and met the inclusion criteria.
In the study, slow breathing exercise training will be given to the experimental group by the coordinator. In their home followmup after discharge, they will be asked to do slow breathing exercises for 10 minutes twice a day for eight weeks. It will be ensured that video calls and breathing exercises are performed together in the form of conference calls.. "Slow Breathing Exercise Training Booklet" and "Slow Breathing Exercise Short Film Video" will be used in the trainings. A calibrated portable digital upper arm sphygmomanometer will be used for heart rate and blood pressure measurement. Groups will be asked to record their own pulse and blood pressure measurements at home.
Data will be collected using the "Patient Information Form", "Mac New Heart Disease Health Related Quality of Life Scale", "VAS Breath Therapy Satisfaction Evaluation Form", "Self-Monitoring Form" and "Patient Follow up Form". Patients will be seen again during the outpatient clinic examination in the fourth and eighth weeks and the effectiveness of slow breathing exercises will be evaluated with data collection forms.
SPSS (IBM Corp., Armonk, NY, USA) program will be used in the analysis of the findings. Before analysis, the normality of the data will be evaluated with the Shapiro-Wilk test. Comparisons between the two groups will be made with descriptive statistics (frequency, percentage, etc.) in the analysis, as well as the Independent Sample t-test (in data with normal distribution) and Mann-Whitney U test (in data that does not show normal distribution) in quantitative data. In comparisons of more than two groups, One-Way Analysis of Variance (One-way ANOVA) or its non-parametric equivalent Kruskal-Wallis test will be used. Paired Samples t-Test or its non-parametric equivalent Wilcoxon test will be used to test the difference in quantitative repeated measurements. Qualitative comparisons between groups will be made with the Chi-Square test. Results, significance in the 95% confidence interval will be evaluated under p<0.05.
- Conditions
- Slow Breathing, Acute Myocardial Infarction
- Being tested
- Slow breathing exercise training
- Keywords
- Blood Pressure, Pulse, Percutaneous Coronary Intervention, Quality of Life, Slow Breathing Exercise
- Medical subject headings
- Hypoventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slow breathing exercise trainingBehavioural
Slow breathing exercise training will be given by the researcher in a single one-hour session in the meeting room of the unit 24 hours after the PCI and/or the next day. After a 20-minute silent rest in the training, patients will be asked to breathe slowly through the nostrils for 4 seconds and slowly exhale through the mouth for 6 seconds to reach 6-8 breaths/min. The patient will rest for 5 seconds after every 6 slow breaths. During the training period, a stopwatch will be used by observing the patient's chest and abdominal movements in order to determine whether the patients have reached the required respiratory rate.
| Study group | Role | What they receive |
|---|---|---|
| Slow breathing exercise training | Experimental | Slow breathing exercise training will be given to patients in the experimental group. After discharge, patients will be asked to do slow breathing exercises twice a day for 10 minutes every day for eight weeks. Daily and/or weekly online, weekday, weekend, daytime, evening, video phone calls will be made with patients who are discharged at the end of the training to practice the slow breathing exercise every day according to the patients' demand. It will be provided that breathing exercises will be performed together with a video call in the form of a conference call. Patients will be asked to take measurements a total of two days a week, one day on weekdays and one day on weekends, in the morning, after a light breakfast, at least five minutes of rest and breathing exercises. Pulse and blood pressure measurements at home on weekdays will be asked to be measured Decouply from breathing exercise, and on weekends before and after breathing exercise. Receives: Behavioral: Slow breathing exercise training |
| Control group | No intervention | In the control group, patients will be shown and told self-blood pressure and pulse measurement at home at discharge. A reminder text message will be sent to the mobile phones of patients for blood pressure and pulse measurement at home. The control group will also be asked to perform their own blood pressure and pulse monitoring at home and record a Self-Monitoring Form (for the Control group).During home follow-up, patients will be sent reminder text messages to their mobile phones two days a week. According to the request of patients, daily and/or weekly online, weekdays, weekends, daytime, evening, phone calls will be made to measure pulse and blood pressure values two days a week. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Slow breathing exercise changes the pulse rate
The pulse rate in the experimental group that applied slow breathing exercises after Percutaneous Coronary Intervention is expected to be statistically significantly (p<0.05) lower than the control group.
A calibrated portable digital upper arm blood pressure monitor purchased within the scope of the TUBITAK project will be delivered to the patient to measure pulse values.
Volunteers will be asked to take measurements twice a week, one weekday and one weekend, in the morning, after a very light breakfast or 2 to 4 hours after a meal, and after at least five minutes of rest and breathing exercise.
The experimental group's heart rate will be measured at home on weekdays, independently of the breathing exercise, and on the weekends, before and after the breathing exercise.
Patients will be given a patient follow up form to record data.
Measured: 2 months
Slow breathing exercise changes systolic blood pressure
Systolic blood pressure in the experimental group that applied slow breathing exercises after Percutaneous Coronary Intervention is expected to be statistically significantly lower (p<0.05) than the control group.
A calibrated portable digital upper arm blood pressure monitor purchased within the scope of the TUBITAK project will be delivered to the patient to measure blood pressure values.
Volunteers will be asked to take measurements two days a week, one weekday and one weekend, in the morning, after a very light breakfast or 2 to 4 hours after a meal, and after at least five minutes of rest and breathing exercise.
The experimental group's blood pressure measurements will be measured at home during the weekdays, independently of the breathing exercise, and on the weekends, before and after the breathing exercise.
Patients will be given a patient follow up form to record data.
Measured: 2 months
Slow breathing exercise changes diastolic blood pressure
Diastolic blood pressure in the experimental group that applied slow breathing exercises after Percutaneous Coronary Intervention is expected to be statistically significantly lower (p<0.05) than the control group.
A calibrated portable digital upper arm blood pressure monitor purchased within the scope of the TUBITAK project will be delivered to the patient to measure blood pressure values.
Volunteers will be asked to take measurements two days a week, one weekday and one weekend, in the morning, after a very light breakfast or 2 to 4 hours after a meal, and after at least five minutes of rest and breathing exercise.
The experimental group's blood pressure measurements will be measured at home during the weekdays, independently of the breathing exercise, and on the weekends, before and after the breathing exercise.
Patients will be given a patient follow up form to record data.
Measured: 2 months
Mac New Heart Disease Health Related Quality of Life Scale
Mac New Heart Disease Health Related Quality of Life Questionnaire is a scale developed by Oldridge et al. in 1991 to determine the quality of life of patients after Myocardial Infarction. This scale is designed to evaluate how physical, emotional, social functions and daily activities are affected by Coronary Artery Disease over a two week period.
This scale consists of three subscales and 27 items: physical limitation scale (n=13), emotional function scale (n=14) and social function scale (n=13).
Scores range from 1 to 7 on average. A low score indicates worse quality of life, a high score indicates better quality of life. Some of the items contain more than one sub-dimension. Subscale scores are calculated by averaging the answers to questions in each subscale, and considering possible scores ranging from 1 to 7, higher scores indicate a better quality of life.
Cronbach Alpha Value is > 0.93. Written permission was obtained for the use of the scale.
Measured: 2 months
Secondary outcomes (1)
Satisfaction of Breathing Exercise
Visual Analog Scale will be used to evaluate patients' satisfaction with breathing therapy. A score of 'one' on the scale indicates that they are dissatisfied with the applied breathing therapy, a score of 'five' indicates that satisfaction is moderate, a score of '10' indicates that satisfaction is very high, and it will be indicated that satisfaction increases as the score increases. Patients will be asked to rate the level of satisfaction with breathing therapy.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start23 Oct 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Slow BreathingStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Melike Çelik, Saglik Bilimleri Universitesi
- Investigators
- Melike CELIK, Lecturer, Principal investigator, Marmara UniversitySelda CELIK, Assoc.Prof., Study director, University of Health scienceMELİKE CELİK, Lecturer, Study chair, 905321562205
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098222
- Sponsor's protocol ID
- TUBITAKprojectnumbered223S237
- Other IDs
- 223S237
- Status last verified
- Nov 2023
- First submitted
- 5 Oct 2023
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD sharing will be decided after the data collection has been started. It is planned to share the study protocol.
Publications
Celik M, Celik S. Effects of Slow Breathing Exercises on Heart Rate, Blood Pressure, and Quality of Life in Patients Undergoing Primary Percutaneous Coronary Intervention: Randomized Controlled Trial. Appl Psychophysiol Biofeedback. 2026 Feb 2. doi: 10.1007/s10484-026-09767-9. Online ahead of print.
PubMed 41627721
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Slow Breathing Exercise Applied to Patients After Primary Percutaneous Coronary Intervention on Pulse, Blood Pressure and Quality of Life
- ClinicalTrials.gov ID
- NCT06098222
- Acronym / sponsor ID
- TUBITAKprojectnumbered223S237
- Conditions
- Slow Breathing, Acute Myocardial Infarction
- Keywords
- Blood Pressure, Pulse, Percutaneous Coronary Intervention, Quality of Life, Slow Breathing Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 24 Oct 2023 (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 was designed as a randomized controlled experimental type in order to determine the effect of slow breathing exercise applied after the procedure on heart rate, blood pressure and quality of life in patients who underwent Primary Percutaneous Coronary Intervention (PCI) I after the diagnosis of ST Elevation Myocardial Infarction (STEMI).
Patients who underwent primary PCI due to STEMI in a Training and Research Hospital in Istanbul will constitute the study population. A sample will be formed with a total of 80 patients, 40 experimental and 40 control groups, selected by computer assisted simple randomization method among volunteer patients who underwent primary PCI and met the inclusion criteria.
In this study, slow breathing exercise training will be given to the experimental group by the coordinator. In their home followmup after discharge, they will be asked to do slow breathing exercises for 10 minutes twice a day for eight weeks.
Data will be collected using the "Patient Information Form", "MacNew Heart Disease Health Related Quality of Life Scale", "VAS Breath Therapy Satisfaction Evaluation Form", "Self-Monitoring Form" and "Patient Follow up Form". Patients will be seen again during the outpatient clinic examination in the fourth and eighth weeks and the effectiveness of slow breathing exercises will be evaluated with data collection forms.
Detailed description
Cardiovascular Diseases (CVD) is still the leading cause of death in the world and in our country, despite significant advances in its diagnosis and treatment. Acute Coronary Syndromes (ACS), which are among the CVD's, occur with the deterioration of the integrity of the atherosclerotic plaque in the coronary vessels. The deadliest form of ACS is ST Elevation Myocardial Infarction (STEMI).
Primary Percutaneous Coronary Intervention (PCI) is recommended primarily in the treatment of acute myocardial infarction. In these patients, changes in vital signs resulting from diagnosis and treatment and a permanent effect on quality of life can be observed.
Slow breathing exercise is a behavioral technique in which a low breathing rate is applied. Breathing exercises reduce heart rate, blood pressure, reduce anxiety and pain while shown to improve symptoms and improve quality of life in patients with chronic obstructive pulmonary disease and asthma. This technique provides conscious deep and slow breathing and effective breathing, as well as improving conscious control over relaxation and increasing awareness.
This study was designed as a randomized controlled experimental type in order to determine the effect of slow breathing exercise applied after the procedure on heart rate, blood pressure and quality of life in patients who underwent PCI after the diagnosis of STEMI. Study data will be collected between 23 October 2023- 30 April 2024 Patients who underwent primary PCI due to STEMI in a Training and Research Hospital in Istanbul will constitute the study population. A sample will be formed with a total of 80 patients, 40 experimental and 40 control groups, selected by computer assisted simple randomization method among volunteer patients who underwent primary PCI and met the inclusion criteria.
In the study, slow breathing exercise training will be given to the experimental group by the coordinator. In their home followmup after discharge, they will be asked to do slow breathing exercises for 10 minutes twice a day for eight weeks. It will be ensured that video calls and breathing exercises are performed together in the form of conference calls.. "Slow Breathing Exercise Training Booklet" and "Slow Breathing Exercise Short Film Video" will be used in the trainings. A calibrated portable digital upper arm sphygmomanometer will be used for heart rate and blood pressure measurement. Groups will be asked to record their own pulse and blood pressure measurements at home.
Data will be collected using the "Patient Information Form", "Mac New Heart Disease Health Related Quality of Life Scale", "VAS Breath Therapy Satisfaction Evaluation Form", "Self-Monitoring Form" and "Patient Follow up Form". Patients will be seen again during the outpatient clinic examination in the fourth and eighth weeks and the effectiveness of slow breathing exercises will be evaluated with data collection forms.
SPSS (IBM Corp., Armonk, NY, USA) program will be used in the analysis of the findings. Before analysis, the normality of the data will be evaluated with the Shapiro-Wilk test. Comparisons between the two groups will be made with descriptive statistics (frequency, percentage, etc.) in the analysis, as well as the Independent Sample t-test (in data with normal distribution) and Mann-Whitney U test (in data that does not show normal distribution) in quantitative data. In comparisons of more than two groups, One-Way Analysis of Variance (One-way ANOVA) or its non-parametric equivalent Kruskal-Wallis test will be used. Paired Samples t-Test or its non-parametric equivalent Wilcoxon test will be used to test the difference in quantitative repeated measurements. Qualitative comparisons between groups will be made with the Chi-Square test. Results, significance in the 95% confidence interval will be evaluated under p<0.05.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Slow breathing exercise training | Experimental | Behavioral: Slow breathing exercise trainingSlow breathing exercise training will be given to patients in the experimental group. After discharge, patients will be asked to do slow breathing exercises twice a day for 10 minutes every day for eight weeks. Daily and/or weekly online, weekday, weekend, daytime, evening, video phone calls will be made with patients who are discharged at the end of the training to practice the slow breathing exercise every day according to the patients' demand. It will be provided that breathing exercises will be performed together with a video call in the form of a conference call. Patients will be asked to take measurements a total of two days a week, one day on weekdays and one day on weekends, in the morning, after a light breakfast, at least five minutes of rest and breathing exercises. Pulse and blood pressure measurements at home on weekdays will be asked to be measured Decouply from breathing exercise, and on weekends before and after breathing exercise. |
| Control group | No intervention | –In the control group, patients will be shown and told self-blood pressure and pulse measurement at home at discharge. A reminder text message will be sent to the mobile phones of patients for blood pressure and pulse measurement at home. The control group will also be asked to perform their own blood pressure and pulse monitoring at home and record a Self-Monitoring Form (for the Control group).During home follow-up, patients will be sent reminder text messages to their mobile phones two days a week. According to the request of patients, daily and/or weekly online, weekdays, weekends, daytime, evening, phone calls will be made to measure pulse and blood pressure values two days a week. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Young adult patients between the ages of 18-65,
- Patients who have not received fibrinolytic therapy before or simultaneously with Percutaneous Coronary Intervention (PCI) procedure,
- Patients who have passed 24 hours after the PCI procedure,
- Patients with a pulse > 60/min (whether or not beta blockers are used after PCI),
- Patients without rhythm problems,
Key exclusion criteria (13 listed)
- Patients with elective/appointed appointments for whom PCI is planned in advance,
- Patients whose PCI procedure failed,
- Patients who underwent only thrombus aspiration and balloon angioplasty during the PCI procedure,
- Patients who have previously undergone PCI and at least one year has not passed since,
- Patients who do not comply with planned interventions,
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 breathing exercise trainingSlow breathing exercise training will be given by the researcher in a single one-hour session in the meeting room of the unit 24 hours after the PCI and/or the next day. After a 20-minute silent rest in the training, patients will be asked to breathe slowly through the nostrils for 4 seconds and slowly exhale through the mouth for 6 seconds to reach 6-8 breaths/min. The patient will rest for 5 seconds after every 6 slow breaths. During the training period, a stopwatch will be used by observing the patient's chest and abdominal movements in order to determine whether the patients have reached the required respiratory rate. | Behavioural | Slow breathing exercise training |
Primary outcome
Slow breathing exercise changes the pulse rate
Time frame: 2 months
The pulse rate in the experimental group that applied slow breathing exercises after Percutaneous Coronary Intervention is expected to be statistically significantly (p<0.05) lower than the control group. A calibrated portable digital upper arm blood pressure monitor purchased within the scope of the TUBITAK project will be delivered to the patient to measure pulse values. Volunteers will be asked to take measurements twice a week, one weekday and one weekend, in the morning, after a very light breakfast or 2 to 4 hours after a meal, and after at least five minutes of rest and breathing exercise. The experimental group's heart rate will be measured at home on weekdays, independently of the breathing exercise, and on the weekends, before and after the breathing exercise. Patients will be given a patient follow up form to record data.
Slow breathing exercise changes systolic blood pressure
Time frame: 2 months
Systolic blood pressure in the experimental group that applied slow breathing exercises after Percutaneous Coronary Intervention is expected to be statistically significantly lower (p<0.05) than the control group. A calibrated portable digital upper arm blood pressure monitor purchased within the scope of the TUBITAK project will be delivered to the patient to measure blood pressure values. Volunteers will be asked to take measurements two days a week, one weekday and one weekend, in the morning, after a very light breakfast or 2 to 4 hours after a meal, and after at least five minutes of rest and breathing exercise. The experimental group's blood pressure measurements will be measured at home during the weekdays, independently of the breathing exercise, and on the weekends, before and after the breathing exercise. Patients will be given a patient follow up form to record data.
Slow breathing exercise changes diastolic blood pressure
Time frame: 2 months
Diastolic blood pressure in the experimental group that applied slow breathing exercises after Percutaneous Coronary Intervention is expected to be statistically significantly lower (p<0.05) than the control group. A calibrated portable digital upper arm blood pressure monitor purchased within the scope of the TUBITAK project will be delivered to the patient to measure blood pressure values. Volunteers will be asked to take measurements two days a week, one weekday and one weekend, in the morning, after a very light breakfast or 2 to 4 hours after a meal, and after at least five minutes of rest and breathing exercise. The experimental group's blood pressure measurements will be measured at home during the weekdays, independently of the breathing exercise, and on the weekends, before and after the breathing exercise. Patients will be given a patient follow up form to record data.
Mac New Heart Disease Health Related Quality of Life Scale
Time frame: 2 months
Mac New Heart Disease Health Related Quality of Life Questionnaire is a scale developed by Oldridge et al. in 1991 to determine the quality of life of patients after Myocardial Infarction. This scale is designed to evaluate how physical, emotional, social functions and daily activities are affected by Coronary Artery Disease over a two week period. This scale consists of three subscales and 27 items: physical limitation scale (n=13), emotional function scale (n=14) and social function scale (n=13). Scores range from 1 to 7 on average. A low score indicates worse quality of life, a high score indicates better quality of life. Some of the items contain more than one sub-dimension. Subscale scores are calculated by averaging the answers to questions in each subscale, and considering possible scores ranging from 1 to 7, higher scores indicate a better quality of life. Cronbach Alpha Value is > 0.93. Written permission was obtained for the use of the scale.
1 secondary outcome
Satisfaction of Breathing Exercise
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Derived from this study: PubMed 41627721Celik M, Celik S. Effects of Slow Breathing Exercises on Heart Rate, Blood Pressure, and Quality of Life in Patients Undergoing Primary Percutaneous Coronary Intervention: Randomized Controlled Trial. Appl Psychophysiol Biofeedback. 2026 Feb 2. doi: 10.1007/s10484-026-09767-9. Online ahead of print.
- Individual participant dataSharing planned: No. The IPD sharing will be decided after the data collection has been started. It is planned to share the study protocol.
Related trials for Slow Breathing
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Recruiting
Assessing the Acute Effects of Virtual Reality Interventions on Stress
Slow Breathing
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
Not yet recruitingObservational study
EEG Markers From Polysomnography and Cognitive Performance in Obstructive Sleep Apnea
Obstructive Sleep Apnea, Cognitive Impairment
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.
Melike CELIK, Lecturer principal investigator
Marmara University
Selda CELIK, Assoc.Prof. study director
University of Health science
MELİKE CELİK, Lecturer study chair
905321562205
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 breathing exercise training in people with Slow Breathing and Acute Myocardial Infarction, run by Saglik Bilimleri Universitesi 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 15 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 7 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melike CELIK, Lecturer (905321562205, melike.celik@marmara.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Slow breathing exercise changes the pulse rate (time frame: 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06098222, which also lists 1 linked publication.
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 Dec 2023.