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CTRI Number  CTRI/2024/09/073617 [Registered on: 09/09/2024] Trial Registered Prospectively
Last Modified On: 22/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Effectiveness of Benson’s Relaxation Technique with Arm Ergometer in Patients after Coronary Artery Bypass Surgery  
Scientific Title of Study   Effectiveness of Benson’s Relaxation Technique with Arm Ergometer to Improve Lung Efficiency, Pain Intensity and Quality of Life in Patients After Coronary Artery Bypass Grafting  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Barvi Bandral 
Designation  MPT Student 
Affiliation  Mahatma Gandhi University of Medical Sciences and Technology, Jaipur 
Address  Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO Institutional Area, Sitapura, Tonk Road, Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  6006475305  
Fax    
Email  barvi1975@mgumst.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr Yuthika Rao 
Designation  Associate Professor  
Affiliation  Mahatma Gandhi University of Medical Sciences and Technology, Jaipur 
Address  Cardiopulmonary Physiotherapy Lab, Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO Institutional Area, Sitapura, Tonk Road, Japiur

Jaipur
RAJASTHAN
302022
India 
Phone  9530096172  
Fax    
Email  physioyuths@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Yuthika Rao 
Designation  Associate Professor  
Affiliation  Mahatma Gandhi University of Medical Sciences and Technology, Jaipur 
Address  Cardiopulmonary Physiotherapy Lab, Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO Institutional Area, Sitapura, Tonk Road, Japiur

Jaipur
RAJASTHAN
302022
India 
Phone  9530096172  
Fax    
Email  physioyuths@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, Jaipur 
 
Primary Sponsor  
Name  Barvi Bandral 
Address  Ward no 1, Near GMS Ramkot, Billawar, Ramkot, Kathua, Jammu and Kashmir 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Yuthika Rao  Mahatma Gandhi Physiotherapy College, MGUMST, Jaiipur  Mahatma Gandhi University of Medical Sciences & Technology, RIICO Institutional Area, Sitapura, Tonk Road, Jaipur, 302022
Jaipur
RAJASTHAN 
9530096172

physioyuths@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Mahatma Gandhi Medical College and Hospital, MGUMST, Jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I258||Other forms of chronic ischemic heart disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Benson’s Relaxation Technique with Arm Ergometer   Warm-up exercises: Breathing exercises (Diaphragmatic breathing and pursed lip breathing) followed by gentle movements of upper limb (shoulder shrugs, elbow movements, wrist pumps). To initiate the arm ergometer post-operative day 1, we will follow the FITT principle for exercise prescription as follows: Frequency: We will give two sessions per day. Intensity: The intensity will be low to moderate with no resistance. Monitor heart rate (aim for 40-50% of heart rate reserve) and ensure it stays within the prescribed limits. Time: We will begin with exercise using arm ergometer as tolerable to the patient. Type: We will use an arm ergometer for cardiovascular exercise and emphasize controlled and smooth movements to avoid excessive strain. We will include both forward and backward pedalling as well as proper body positioning. To initiate the Benson Relaxation Response, we will take the following steps: Take a comfortable seat and sit quietly. Close your eyes. Let all of your muscles relax fully. Inhale via your nose. Pay attention to how you breathe. Say the word "ONE" to yourself in silence as you exhale. Take a breath, for instance, IN—OUT, "ONE": IN—OUT, "ONE": etc. Inhale smoothly and instinctively. Keep going for ten to twenty minutes. To check the time, you can open your eyes, but avoid setting an alarm. After youre done, take a few minutes to sit quietly, first with your eyes closed and then with them open. Keep down your feet for a few minutes. 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Subjects who underwent CABG in the hospital.
Subjects with ejection fraction ranging from 50% and more.
Subjects that will be medically and clinically stable after surgery will be taken.
Subjects willing to participate in the study.
Subjects able to provide verbal and written consent. 
 
ExclusionCriteria 
Details  Subjects who had developed hemodynamic complications (e.g. lung congestion, subjects on intra-aortic balloon, preoperative myocardial infarction).
Subjects with ejection fraction less than 50%.
Post-operative renal failure.
Post-operative arrhythmia needed for a pacemaker.
Post-operative mechanical ventilation (more than 24 hours).
Previous history of cardiac surgery. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Numeric Pain Rating Scale (NPRS)
Incentive Spirometer
36-Item Short Form Survey (SF-36) 
7 days 
 
Secondary Outcome  
Outcome  TimePoints 
Incentive Spirometer  2nd day, 5th day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   30/09/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

The eligibility of the participants will be taken on the basis of the inclusion criteria of this research study. The informed consent will be taken from 60 subjects that will be selected according to the inclusion criteria.

Pre-Operative Procedure:- All the patients who will be involved in the study will be given consent form for their willingness to participate in the study. 

The demographic data of the patient will be taken pre-operatively. 

The patients will be instructed and taught about the Bensons relaxation technique that contains all the breathing techniques.

The patients will be taught about arm ergometer and its significance.

Post-Operative Procedure:- Post-operative program will be started after the patient will be extubated from the mechanical ventilator. 

The patient must be hemodinamically stable from the first day till the day of discharge from CTVS at least for 7 days after the surgery (post-operatively)

The pain levels of the patient will be assessed using Numeric Pain Rating Scale (NPRS) after surgery at day 1 and day 7.

The patient’s inspiratory and expiratory capacity will be measured using 3-ball incentive spirometer and quality of life will be assessed using SF-36 questionnaire on day 1 and then on day 7.

Treatment Protocol:

Warm-up exercises: Breathing exercises (Diaphragmatic breathing and pursed lip breathing) followed by gentle movements of upper limb (shoulder shrugs, elbow movements, wrist pumps).

To initiate the arm ergometer post-operative day 1, we will follow the FITT principle for exercise prescription as follows:

Frequency: We will give two sessions per day.

Intensity: The intensity will be low to moderate with no resistance. Monitor heart rate (aim for 40-50% of heart rate reserve) and ensure it stays within the prescribed limits.

Time: We will begin with exercise using arm ergometer as tolerable to the patient.

Type: We will use an arm ergometer for cardiovascular exercise and emphasize controlled and smooth movements to avoid excessive strain. We will include both forward and backward pedalling as well as proper body positioning.

To initiate the Benson Relaxation Response, we will take the following steps:

Take a comfortable seat and sit quietly.

Close your eyes.

Let all of your muscles relax fully.

Inhale via your nose. Pay attention to how you breathe. Say the word "ONE" to yourself in silence as you exhale. Take a breath, for instance, IN and OUT, "ONE": IN and OUT, "ONE": etc. Inhale smoothly and instinctively.

Keep going for ten to twenty minutes. To check the time, you can open your eyes, but avoid setting an alarm. After you are done, take a few minutes to sit quietly, first with your eyes closed and then with them open. Keep down your feet for a few minutes.

 
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