Effect of Deep Breathing Exercises on Post Operative Sleep Duration

• Sponsor: Riphah International University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05058222
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.5
• Patients Per Site Per Month: 1.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Bypass Graft	Other: Deep Breathing Exercise after every 3hrs, each session consists of 10 deep breaths Exercise; Other: Deep Breathing Exercise after every 3hrs, each session consist of 30 deep breaths Exercise	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Effect of Deep Breathing Exercises on Post Operative Sleep Duration and Quality in Patients Undergoing CABG (Coronary Artery Bypass Graft).
• Actual Study Start Date: Oct 15, 2020
• Actual Primary Completion Date: Dec 30, 2021
• Actual Study Completion Date: Dec 30, 2021

Arms and Interventions

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.	Other: Deep Breathing Exercise after every 3hrs, each session consists of 10 deep breaths Exercise; • 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).	Other: Deep Breathing Exercise after every 3hrs, each session consist of 30 deep breaths Exercise; • 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).

Outcome Measures

Primary Outcome Measures

1. St Mary's Hospital Sleep Questionnaire (SMHSQ) [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.

2. St Mary's Hospital Sleep Questionnaire (SMHSQ) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 69 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Armed forces Institute of Cardiology	Rawalpindi	Punjab	Pakistan	46000

Sponsors and Collaborators

• Riphah International University

Investigators

• Principal Investigator: Anam Aftab, Phd*, Riphah college of rehabilitation and allied health sciences - Rawalpindi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Riphah International University
• ClinicalTrials.gov Identifier: NCT05058222
• Other Study ID Numbers: REC/00875 Amna Iqbal
• First Posted: Sep 27, 2021
• Last Update Posted: Jan 11, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Riphah International University: Breathing exercises; Coronary artery bypass; Sleep
• Additional relevant MeSH terms: Respiratory Aspiration

Study Results

No Results Posted as of Jan 11, 2022