Effect of Deep Breathing Exercises on Post Operative Sleep Duration
Primary Purpose
Coronary Artery Bypass Graft
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Deep Breathing Exercise after every 3hrs, each session consists of 10 deep breaths Exercise
Deep Breathing Exercise after every 3hrs, each session consist of 30 deep breaths Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Bypass Graft focused on measuring Breathing exercises, Coronary artery bypass, Sleep
Eligibility Criteria
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.
Sites / Locations
- Armed forces Institute of Cardiology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Deep breathing ex (10 reps) Group
Deep breathing ex (30 reps) Group
Arm Description
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 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).
Outcomes
Primary Outcome Measures
St Mary's Hospital Sleep Questionnaire (SMHSQ)
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.
St Mary's Hospital Sleep Questionnaire (SMHSQ)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05058222
First Posted
March 6, 2021
Last Updated
January 8, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05058222
Brief Title
Effect of Deep Breathing Exercises on Post Operative Sleep Duration
Official Title
Effect of Deep Breathing Exercises on Post Operative Sleep Duration and Quality in Patients Undergoing CABG (Coronary Artery Bypass Graft).
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Bypass Graft
Keywords
Breathing exercises, Coronary artery bypass, Sleep
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Deep breathing ex (10 reps) Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Deep breathing ex (30 reps) Group
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Deep Breathing Exercise after every 3hrs, each session consists of 10 deep breaths Exercise
Intervention Description
• 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.
Intervention Type
Other
Intervention Name(s)
Deep Breathing Exercise after every 3hrs, each session consist of 30 deep breaths Exercise
Intervention Description
• 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).
Primary Outcome Measure Information:
Title
St Mary's Hospital Sleep Questionnaire (SMHSQ)
Description
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.
Time Frame
Baseline
Title
St Mary's Hospital Sleep Questionnaire (SMHSQ)
Description
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.
Time Frame
3 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anam Aftab, Phd*
Organizational Affiliation
Riphah college of rehabilitation and allied health sciences - Rawalpindi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Armed forces Institute of Cardiology
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Deep Breathing Exercises on Post Operative Sleep Duration
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