RespiratoryNCT06485531
The Effect of Pranayama on Pain and Respiration After Coronary Bypass Surgery
A study testing Pranamaya and Pursed Lips Breathing in people with Respiratory and Postoperative Pain, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
After CABG surgery, patients tend to breathe superficially because they experience pain while breathing. By restricting deep inspiration and cough; There is a decrease in lung tidal volume, vital capacity, and functional residual capacity. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Respiratory, Postoperative Pain, Nursing
- What is being tested?
- Pranamaya and Pursed Lips Breathing
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2022to 22 May 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- CABG surgery performed on a stopped heart (On pump),
- Cardiopulmonary risk index score ≤2
- Those aged 18 and over,
- Being literate and communicative,
- American Society of Anesthesiologists (ASA) classification I or II,
- Preoperative respiratory function tests with normal FEV1, FVC, FEV1/FVC values,
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- No complications developed during and after the surgical intervention,
- An analgesic drug with the same active ingredient is applied to control pain after surgical intervention,
- Patients who were administered antibiotics with the same active ingredient after surgical intervention were included.
Who cannot join
- CABG surgery performed on a working heart (off-pump),
- Cardiopulmonary risk index score ≥4
- Complications developing during or after surgery,
- Intubated,
- Those with chronic pain in the pre-surgical period,
- Those with limited movement activity before surgery,
- Having a body mass index (BMI≥30),
- Patients who could not adapt to and tolerate the pranayama technique were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Pranayama and Pursed Lip Breathing Exercise on Pain and Respiration After Coronary Bypass Surgery
After CABG surgery, patients tend to breathe superficially because they experience pain while breathing. By restricting deep inspiration and cough; There is a decrease in lung tidal volume, vital capacity, and functional residual capacity. Accordingly, alveolar ventilation also decreases, and the oxygenation levels of the organs decrease due to alveolar collapse or developing hypoxemia. Due to the pain experienced, patients cannot cough and secretions accumulate in the alveoli. Due to accumulated secretions, patients are more prone to atelectasis and lung infections. The risk of pulmonary embolism increases in patients due to the limitation of movement caused by pain. It is aimed to replace these weak breathing patterns with conscious breathing patterns provided by pranayama. While pranayama improves regular, slow, and deep breathing, it activates nasal breathing and provides diaphragmatic breathing. Thanks to the suction pressure created in the chest cavity with diaphragmatic breathing, the venous return of blood also improves. Along with all these changes, it also helps reduce the heart's workload by regulating circulatory functions such as blood pressure, heart rate, left ventricular pressure, and coronary artery diameter. Alternating nasal breathing, slow and deep breathing, applied during pranayama, helps relieve breathing work in eliminating excessive breathing patterns. In addition, nasal breathing balances sympathetic and parasympathetic activity and makes an important contribution to the regulation of the activities of the autonomic nervous system. The vagus nerve, which has a parasympathetic effect, stimulates the left nostril, diagram, stomach, hypothalamus, pineal gland, and suprachiasmatic nucleus and stimulates the diaphragm and stomach, and with this control of the autonomic nervous system, it helps to keep the respiratory rate within normal ranges, improve breathing, reduce stress hormones and help relaxation. Controlled inspiration, breath holding, and slow expiration practices performed with pranayama also contribute to increasing the general capacity of the lungs and gradually improving respiratory functions.
- Conditions
- Respiratory, Postoperative Pain, Nursing
- Being tested
- Pranamaya, Pursed Lips Breathing
- Keywords
- CABG, pranayama, pain, respiration, nursing
- Medical subject headings
- Pain, Postoperative, Pain, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PranamayaOther
Pranamaya
Pursed Lips BreathingOther
Pursed Lips Breathing
| Study group | Role | What they receive |
|---|---|---|
| Pranayama | Active comparator | Nadi Shothana Pranayama was applied to the patients for 15 minutes before the surgery and for 7 days after the surgery. After the application, FVC, FEV1, and FEV1/FVC values were measured with a spirometer (Contec Spirometer SP70B, Contec Medical Systems Co,. Ltd., China) and recorded in the Patient Follow-up Form. In cases where the patient did not perform well, the measurement was repeated at least three times and the best data was taken. Systolic and diastolic blood pressure, heart rate, respiratory rate, and peripheral oxygen saturation, which were thought to affect the results of FVC, FEV1, and FEV1/FVC values, were also measured and recorded. In addition, hematocrit level, analgesia dose, and amounts used during the day were recorded daily and in the Patient Follow-up Form. Pain levels were evaluated 4 times daily (10:00-14:00-22:00-06:00) during the 0th to 6th days after surgery and recorded on the Visual Analog Scale Form. Receives: Other: Pranamaya |
| Pursed Lips Breathing | Sham comparator | Pursed Lip Breathing Exercise was applied to the patients before and after the surgery for 15 minutes. After the application, FVC, FEV1, and FEV1/FVC values were measured with a spirometer (Contec Spirometer SP70B, Contec Medical Systems Co., Ltd., China) and recorded in the Patient Follow-up Form. (Annex-3). In cases where the patient did not perform well, the measurement was repeated at least three times and the best data was taken. Systolic and diastolic blood pressure, heart rate, respiratory rate, and peripheral oxygen saturation, which are thought to affect the results of FVC, FEV1, and FEV1/FVC values, were also measured and recorded before and after the application. In addition, hematocrit level, analgesia dose, and amounts used during the day were recorded daily and in the Patient Follow-up Form. Pain levels were evaluated 4 times daily (10:00-14:00-22:00-06:00) during the 0th to 6th days after surgery and recorded on the Visual Analog Scale Form. Receives: Other: Pursed Lips Breathing |
| Control | No intervention | No intervention was made to the control group patients. FVC, FEV1 and FEV1/FVC values of the patients were measured with a spirometer (Contec Spirometer SP70B, Contec Medical Systems Co., Ltd., China) before the surgery and for 7 days after the surgery. In cases where the patient did not perform well, the measurement was repeated at least three times and the best data was taken. Systolic and diastolic blood pressure, heart rate, respiratory rate, and peripheral oxygen saturation, which are thought to affect the results of FVC, FEV1, and FEV1/FVC values, were also measured and recorded at 15-minute intervals. In addition, the hematocrit level, the dose, and amount of analgesia used during the day were recorded daily and in the Patient Follow-up Form. Pain levels were evaluated 4 times daily (10:00-14:00-22:00-06:00) during the 0th to 6th days after surgery and recorded on the Visual Analog Scale Form. |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative FVC
Improvement in FVC in patients treated with Pranayama after CABG
Measured: From admission to discharge, up to 1 week
FEV1
Improvement in FEV1 in patients treated with Pranayama after CABG
Measured: From admission to discharge, up to 1 week
FEV1/FVC level
Improvement in FEV1/FVC level in patients treated with Pranayama after CABG
Measured: From admission to discharge, up to 1 week
Change in postoperative pain measured by VAS
Change in postoperative pain measured by VAS in patients who underwent pranayama after CABG
Measured: From surgery to 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start15 Mar 2022
- Primary completion22 May 2023
- Study completion22 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RespiratoryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugba ALBAYRAM, Istanbul University - Cerrahpasa
- Investigators
- Tuğba Albayram, Principal investigator, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485531
- Sponsor's protocol ID
- TALBAYRAM
- Status last verified
- Jul 2024
- First submitted
- 18 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be made available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pranayama and Pursed Lip Breathing Exercise on Pain and Respiration After Coronary Bypass Surgery
- ClinicalTrials.gov ID
- NCT06485531
- Acronym / sponsor ID
- TALBAYRAM
- Conditions
- Respiratory, Postoperative Pain, Nursing
- Keywords
- CABG, pranayama, pain, respiration, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 22 May 2023 (actual)
- Study completion
- 22 May 2023 (actual)
- First posted
- 3 Jul 2024 (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.
After CABG surgery, patients tend to breathe superficially because they experience pain while breathing. By restricting deep inspiration and cough; There is a decrease in lung tidal volume, vital capacity, and functional residual capacity. Accordingly, alveolar ventilation also decreases, and the oxygenation levels of the organs decrease due to alveolar collapse or developing hypoxemia. Due to the pain experienced, patients cannot cough and secretions accumulate in the alveoli. Due to accumulated secretions, patients are more prone to atelectasis and lung infections. The risk of pulmonary embolism increases in patients due to the limitation of movement caused by pain. It is aimed to replace these weak breathing patterns with conscious breathing patterns provided by pranayama. While pranayama improves regular, slow, and deep breathing, it activates nasal breathing and provides diaphragmatic breathing. Thanks to the suction pressure created in the chest cavity with diaphragmatic breathing, the venous return of blood also improves. Along with all these changes, it also helps reduce the heart's workload by regulating circulatory functions such as blood pressure, heart rate, left ventricular pressure, and coronary artery diameter. Alternating nasal breathing, slow and deep breathing, applied during pranayama, helps relieve breathing work in eliminating excessive breathing patterns. In addition, nasal breathing balances sympathetic and parasympathetic activity and makes an important contribution to the regulation of the activities of the autonomic nervous system. The vagus nerve, which has a parasympathetic effect, stimulates the left nostril, diagram, stomach, hypothalamus, pineal gland, and suprachiasmatic nucleus and stimulates the diaphragm and stomach, and with this control of the autonomic nervous system, it helps to keep the respiratory rate within normal ranges, improve breathing, reduce stress hormones and help relaxation. Controlled inspiration, breath holding, and slow expiration practices performed with pranayama also contribute to increasing the general capacity of the lungs and gradually improving respiratory functions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pranayama | Active comparator | Other: PranamayaNadi Shothana Pranayama was applied to the patients for 15 minutes before the surgery and for 7 days after the surgery. After the application, FVC, FEV1, and FEV1/FVC values were measured with a spirometer (Contec Spirometer SP70B, Contec Medical Systems Co,. Ltd., China) and recorded in the Patient Follow-up Form. In cases where the patient did not perform well, the measurement was repeated at least three times and the best data was taken. Systolic and diastolic blood pressure, heart rate, respiratory rate, and peripheral oxygen saturation, which were thought to affect the results of FVC, FEV1, and FEV1/FVC values, were also measured and recorded. In addition, hematocrit level, analgesia dose, and amounts used during the day were recorded daily and in the Patient Follow-up Form. Pain levels were evaluated 4 times daily (10:00-14:00-22:00-06:00) during the 0th to 6th days after surgery and recorded on the Visual Analog Scale Form. |
| Pursed Lips Breathing | Sham comparator | Other: Pursed Lips BreathingPursed Lip Breathing Exercise was applied to the patients before and after the surgery for 15 minutes. After the application, FVC, FEV1, and FEV1/FVC values were measured with a spirometer (Contec Spirometer SP70B, Contec Medical Systems Co., Ltd., China) and recorded in the Patient Follow-up Form. (Annex-3). In cases where the patient did not perform well, the measurement was repeated at least three times and the best data was taken. Systolic and diastolic blood pressure, heart rate, respiratory rate, and peripheral oxygen saturation, which are thought to affect the results of FVC, FEV1, and FEV1/FVC values, were also measured and recorded before and after the application. In addition, hematocrit level, analgesia dose, and amounts used during the day were recorded daily and in the Patient Follow-up Form. Pain levels were evaluated 4 times daily (10:00-14:00-22:00-06:00) during the 0th to 6th days after surgery and recorded on the Visual Analog Scale Form. |
| Control | No intervention | –No intervention was made to the control group patients. FVC, FEV1 and FEV1/FVC values of the patients were measured with a spirometer (Contec Spirometer SP70B, Contec Medical Systems Co., Ltd., China) before the surgery and for 7 days after the surgery. In cases where the patient did not perform well, the measurement was repeated at least three times and the best data was taken. Systolic and diastolic blood pressure, heart rate, respiratory rate, and peripheral oxygen saturation, which are thought to affect the results of FVC, FEV1, and FEV1/FVC values, were also measured and recorded at 15-minute intervals. In addition, the hematocrit level, the dose, and amount of analgesia used during the day were recorded daily and in the Patient Follow-up Form. Pain levels were evaluated 4 times daily (10:00-14:00-22:00-06:00) during the 0th to 6th days after surgery and recorded on the Visual Analog Scale Form. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- CABG surgery performed on a stopped heart (On pump),
- Cardiopulmonary risk index score ≤2
- Those aged 18 and over,
- Being literate and communicative,
- American Society of Anesthesiologists (ASA) classification I or II,
Key exclusion criteria (8 listed)
- CABG surgery performed on a working heart (off-pump),
- Cardiopulmonary risk index score ≥4
- Complications developing during or after surgery,
- Intubated,
- Those with chronic pain in the pre-surgical period,
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 |
|---|---|---|
| PranamayaPranamaya | Other | Pranayama |
| Pursed Lips BreathingPursed Lips Breathing | Other | Pursed Lips Breathing |
Primary outcome
postoperative FVC
Time frame: From admission to discharge, up to 1 week
Improvement in FVC in patients treated with Pranayama after CABG
FEV1
Time frame: From admission to discharge, up to 1 week
Improvement in FEV1 in patients treated with Pranayama after CABG
FEV1/FVC level
Time frame: From admission to discharge, up to 1 week
Improvement in FEV1/FVC level in patients treated with Pranayama after CABG
Change in postoperative pain measured by VAS
Time frame: From surgery to 3 days after surgery
Change in postoperative pain measured by VAS in patients who underwent pranayama after CABG
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 3 Jul 2024.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be made available to other researchers
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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.
Tuğba Albayram principal investigator
University of Gaziantep
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pranamaya and Pursed Lips Breathing in people with Respiratory and Postoperative Pain, 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 9 inclusion and 8 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 3 Jul 2024. 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. Some participants in this study may receive a placebo. 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?
postoperative FVC (time frame: From admission to discharge, up to 1 week). 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?
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 3 Jul 2024.