- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06485531
The Effect of Pranayama on Pain and Respiration After Coronary Bypass Surgery
July 2, 2024 updated by: Tugba ALBAYRAM, Istanbul University - Cerrahpasa (IUC)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Şehitkamil
-
Gaziantep, Şehitkamil, Turkey, 27310
- Tuğba Albayram
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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,
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Pranayama
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.
|
Pranamaya
|
|
Sham Comparator: Pursed Lips Breathing
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.
|
Pursed Lips Breathing
|
|
No Intervention: Control
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative FVC
Time Frame: From admission to discharge, up to 1 week
|
Improvement in FVC in patients treated with Pranayama after CABG
|
From admission to discharge, up to 1 week
|
|
FEV1
Time Frame: From admission to discharge, up to 1 week
|
Improvement in FEV1 in patients treated with Pranayama after CABG
|
From admission to discharge, up to 1 week
|
|
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
|
From admission to discharge, up to 1 week
|
|
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
|
From surgery to 3 days after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Tuğba Albayram, University of Gaziantep
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2022
Primary Completion (Actual)
May 22, 2023
Study Completion (Actual)
May 22, 2023
Study Registration Dates
First Submitted
June 18, 2024
First Submitted That Met QC Criteria
July 2, 2024
First Posted (Actual)
July 3, 2024
Study Record Updates
Last Update Posted (Actual)
July 3, 2024
Last Update Submitted That Met QC Criteria
July 2, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TALBAYRAM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data (IPD) will not be made available to other researchers
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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