NCT06485531

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

1.2 years

First QC Date

June 18, 2024

Last Update Submit

July 2, 2024

Conditions

Keywords

CABG, pranayama, pain, respiration, nursing

Outcome Measures

Primary Outcomes (4)

  • postoperative FVC

    Improvement in FVC in patients treated with Pranayama after CABG

    From admission to discharge, up to 1 week

  • FEV1

    Improvement in FEV1 in patients treated with Pranayama after CABG

    From admission to discharge, up to 1 week

  • FEV1/FVC level

    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

    Change in postoperative pain measured by VAS in patients who underwent pranayama after CABG

    From surgery to 3 days after surgery

Study Arms (3)

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.

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.

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.

Interventions

Pranamaya

Pranayama

Pursed Lips Breathing

Pursed Lips Breathing

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tuğba Albayram

Gaziantep, Şehitkamil, 27310, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativePainRespiratory Aspiration

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsRespiration DisordersRespiratory Tract Diseases

Study Officials

  • Tuğba Albayram

    University of Gaziantep

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 18, 2024

First Posted

July 3, 2024

Study Start

March 15, 2022

Primary Completion

May 22, 2023

Study Completion

May 22, 2023

Last Updated

July 3, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be made available to other researchers

Locations