- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07470034
Effects of Diaphragm Release Technique on Sleep Quality and Respiratory Function in Coronary Artery Bypass Graft Patients
Effects of Diaphragm Release Technique on Sleep Quality and Respiratory Functions in Patients Undergoing Coronary Artery Bypass Graft Surgery
This study aims to investigate the effects of diaphragm relaxation technique on sleep quality and respiratory functions in patients who have undergone coronary artery bypass graft (CABG) surgery. Two groups will be formed in the study: one group will receive standard cardiac rehabilitation, while the other group will receive diaphragm relaxation technique in addition to this.
Throughout the study, patients' respiratory functions, sleep quality, respiratory muscle strength, and pain levels will be measured. These measurements will be taken from the patients...
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is an interventional research investigating the effects of the diaphragm release technique on sleep quality and respiratory functions in patients undergoing minimally invasive coronary artery bypass graft (CABG) surgery. Participants will be assigned to either an intervention or a control group. Both groups will receive standard in-hospital cardiac rehabilitation, while the intervention group will additionally receive the diaphragm release technique during their hospital stay.
Data will be collected using standardized tools, including pulmonary function tests (spirometry), respiratory muscle strength measurements, the Pittsburgh Sleep Quality Index, and visual analog scales for pain assessment. Written informed consent will be obtained from all participants, and the study will be conducted at Gaziantep Sanko University Hospital Cardiovascular Surgery Unit in accordance with ethical committee approval.
The aim of this research is to develop a safe and effective method to improve respiratory health and quality of life in patients after cardiac surgery.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
şehitkamil
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Gaziantep, şehitkamil, Turkey (Türkiye), 27500
- Sanko Unıversıty
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age under 65 years
- Undergoing minimally invasive coronary artery bypass graft (CABG) surgery
- Hemodynamically stable
- Ambulatory (able to walk)
- Willing to participate in the study and provide written informed consent
- Mini-Mental State Examination (MMSE) score ≥ 25
Exclusion Criteria:
- History of cerebrovascular events (stroke, TIA)
- Orthopedic problems preventing walking
- Uncontrolled diabetes
- Uncontrolled hypertension
- Severe visual impairment
- Other diseases limiting participation in exercise training (pulmonary, neurological, metabolic, etc.)
- Verbal or auditory cooperation problems
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Diaphragm Release plus Standard Cardiac Rehabilitation
Standard in-hospital cardiac rehabilitation plus diaphragm release technique applied for a minimum of 5 days during hospitalization.
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Participants receive standard in-hospital cardiac rehabilitation plus diaphragm release technique.
The diaphragm release is performed daily during the hospital stay for a minimum o
|
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Active Comparator: Standard In-Hospital Cardiac Rehabilitation
Standard in-hospital cardiac rehabilitation only.
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Participants receive standard in-hospital cardiac rehabilitation only, including breathing exercises, mobilization, and post-operative physiotherapy, without diaphragm release.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pulmonary Function (Spirometry)
Time Frame: 1 years
|
FEV1/FVC ratio measured with a spirometer.
Measurements are performed according to ATS/ERS guidelines.
|
1 years
|
|
Sleep Quality (Pittsburgh Sleep Quality Index)
Time Frame: 1 years
|
sleep latency and daytime dysfunction evaluated using the Pittsburgh Sleep Quality Index.
|
1 years
|
|
Respiratory Muscle Strength (MIP/MEP)
Time Frame: 1 years
|
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measured using an oral pressure device to evaluate respiratory muscle strength.
|
1 years
|
|
Pain Level (Visual Analog Scale)
Time Frame: 1 years
|
Chest and incision site pain assessed using a 0-10 cm Visual Analog Scale (0 = no pain, 10 = worst pain imaginable).
Measured during rest, activity, and night.
|
1 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- burcubagci6
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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