- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05058222
Effect of Deep Breathing Exercises on Post Operative Sleep Duration
January 8, 2022 updated by: Riphah International University
Effect of Deep Breathing Exercises on Post Operative Sleep Duration and Quality in Patients Undergoing CABG (Coronary Artery Bypass Graft).
This study will provide the evidence that during the postoperative period deep breathing exercise combined with physical training can positively influence the sleep duration and quality.
This study will provide the evidence that during the postoperative period deep breathing exercise combined with physical training can positively influence the sleep duration and quality.
Study Overview
Status
Completed
Conditions
Detailed Description
Subjects will be randomly placed into Control group and Interventional group.
The control program will consist of Deep Breathing Exercises (from Morning to night every three hours; each session consisting of 10 deep breaths with a few seconds pause between each set, for 3 days) in addition with progressive Exercises.
Two daily sessions with an average duration of 25 min will be performed.
In addition to the physiotherapeutic program standardized by the hospital's team of physical therapists, the intervention group will perform additional Deep breathing Exercises (from Morning to night every three hours; each session consisting of 30 deep breaths with a few seconds pause between each set, for 3 days).
Deep breathing exercises will start 48 hours after extubation and full education along with the routine care (i.e.: from the fourth to sixth postoperative day).
Study Type
Interventional
Enrollment (Actual)
28
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
-
-
Punjab
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Rawalpindi, Punjab, Pakistan, 46000
- Armed Forces Institute of Cardiology
-
-
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
30 years to 69 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Ability to read and write
- Stabilization of vital signs [blood pressure, pulse, respiration)
- Patient undergoing OFF Pump Coronary Artery Bypass Graft (CABG) Procedure
Exclusion Criteria:
- History of severe mental diseases resulting in hospitalization and drug treatment within the previous 6 months
- Use any kind of other complementary methods such as massage therapy, aromatherapy, etc. to treat sleep disorders for the previous two weeks
- History of sleep or respiration disorders and used CNS medications in the night.
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Deep breathing ex (10 reps) Group
The control program will consist of Deep Breathing Exercises (from Morning to night every three hours; each session consisting of 10 deep breaths with a few seconds pause between each set, for 3 days) in addition with progressive Exercises.
|
• The control program will consist of Deep Breathing Exercises (from Morning to night every three hours; each session consisting of 10 deep breaths with a few seconds pause between each set, for 3 days) in addition with progressive Exercises.
|
|
Experimental: Deep breathing ex (30 reps) Group
The intervention group will perform additional Deep breathing Exercises (from Morning to night every three hours; each session consisting of 30 deep breaths with a few seconds pause between each set, for 3 days).
|
• The intervention group will perform additional Deep breathing Exercises (from Morning to night every three hours; each session consisting of 30 deep breaths with a few seconds pause between each set, for 3 days).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
St Mary's Hospital Sleep Questionnaire (SMHSQ)
Time Frame: Baseline
|
To check the quality of sleep over the past 24 hours.
This SMH tool was a 14 item multiple choice and short answer instrument which examined individuals' previous nights sleep.
|
Baseline
|
|
St Mary's Hospital Sleep Questionnaire (SMHSQ)
Time Frame: 3 week
|
To check the quality of sleep over the past 24 hours.
This SMH tool was a 14 item multiple choice and short answer instrument which examined individuals' previous nights sleep.
|
3 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
October 15, 2020
Primary Completion (Actual)
December 30, 2021
Study Completion (Actual)
December 30, 2021
Study Registration Dates
First Submitted
March 6, 2021
First Submitted That Met QC Criteria
September 17, 2021
First Posted (Actual)
September 27, 2021
Study Record Updates
Last Update Posted (Actual)
January 11, 2022
Last Update Submitted That Met QC Criteria
January 8, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/00875 Amna Iqbal
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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