| CTRI Number |
CTRI/2023/10/059065 [Registered on: 23/10/2023] Trial Registered Prospectively |
| Last Modified On: |
28/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of a Holistic Mind Body treatment in patients
with Coronary Artery Bypass Graft surgery |
|
Scientific Title of Study
|
Effect of a Holistic Mind Body intervention in patients
with Coronary Artery Bypass Graft surgery: a single
blind Randomized Clinical Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shweta Manwadkar |
| Designation |
Principal and Professor |
| Affiliation |
K J Somaiya College of Physiotherapy |
| Address |
Cardiorespiratory Department, Room number - 13, K J Somaiya College of Physiotherapy, Opposite Eastern Express Highway, Everard Nagar, Sion, Mumbai - 400022
Mumbai (Suburban)
MAHARASHTRA
400022
India |
| Phone |
8104017576 |
| Fax |
|
| Email |
shweta@somaiya.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shweta Manwadkar |
| Designation |
Principal and Professor |
| Affiliation |
K J Somaiya College of Physiotherapy |
| Address |
Cardiorespiratory Department, Room number - 13, K J Somaiya College of Physiotherapy, Opposite Eastern Express Highway, Everard Nagar, Sion, Mumbai - 400022
Mumbai (Suburban)
MAHARASHTRA
400022
India |
| Phone |
8104017576 |
| Fax |
|
| Email |
shweta@somaiya.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shweta Manwadkar |
| Designation |
Principal and Professor |
| Affiliation |
K J Somaiya College of Physiotherapy |
| Address |
Cardiorespiratory Department, Room number - 13, K J Somaiya College of Physiotherapy, Opposite Eastern Express Highway, Everard Nagar, Sion, Mumbai - 400022
Mumbai (Suburban)
MAHARASHTRA
400022
India |
| Phone |
8104017576 |
| Fax |
|
| Email |
shweta@somaiya.edu |
|
|
Source of Monetary or Material Support
|
| K J Somaiya college of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
Dr Shweta Manwadkar |
| Address |
K J Somaiya College of Physiotherapy, Opposite Eastern Express Highway, Everard Nagar, Sion, Mumbai - 400022 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shweta Manwadkar |
K J Somaiya Hospital & Research Center |
476-490, Cardiac ICU , Opposite Eastern Express Highway, Everard Nagar, Sion, Mumbai - 400022
Mumbai
MAHARASHTRA |
8104017576
shweta@somaiya.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| K J Somaiya Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mindfulness Meditation along with Standard Physiotherapy |
• Teaching the concept of Mindfulness
• 20 minutes Body scan meditation in lying/sitting once daily
• Specific instructions about being aware of breath, body sensations, acceptance during the meditation period,
• Raisin exercise : eating a raisin mindfully
• Incorporating Mindfulness practice in all daily activities.
• Instructions for home practice will be given at discharge
• Patients will be asked to maintain a meditation log.
• The compliance will be checked telephonically.
• Follow up assessment will be done 4 weeks post-surgery.
|
| Comparator Agent |
Standard Physiotherapy |
• Positioning and postural drainage
• Chest clapping, vibration, coughing (and huffing) exercises, breathing exercises (diaphragmatic breathing, segmental breathing, local expansion, and pursed lip breathing), splinting, flow based incentive spirometer, and thorax mobilization exercises. PEP devices as per need.
• Early mobility in and out of bed by means of bedside exercises, walking. Staircase climbing at discharge.
• Education about risk factors and lifestyle modification advice. Graded customized walking program advice post discharge.
• Subjects will be asked to maintain a practice log. The compliance will be checked telephonically.
• Follow Up assessment will be done 4 weeks post surgery.
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Both males and females
2.Undergoing Elective CABG
3.Age group 40-70 years
4.Medically fit to undergo PT
5.Post-surgery day 1 sternotomy pain >3 on NPRS on movement
|
|
| ExclusionCriteria |
| Details |
1.H/o previous CABG
2.Patients with diagnosed musculoskeletal, neurological , psychiatric conditions , Autoimmune disorders, Malignancy
3.Patients with post op Cardiac, Neurological complications
4.Mini mental scale examination score < 24
Patients having any uncorrected visual, auditory and cognitive problems
5.Patients practicing any form of mediation regularly
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 6 Minute walk test ( 6 MWT) |
1st baseline reading is obtained, outcome measures 6 Min walk test be assessed for 2nd time at discharge & for 3rd time 4 weeks Post Surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Numeric Pain Rating Scale (NPRS) |
1st baseline reading is obtained, outcome measures for 2nd time Post Operation Day 1 , 3rd time at discharge & for 4th time 4 weeks Post Surgery |
| Hospital Anxiety Depression Scale (HADS) |
1st baseline reading is obtained, outcome measures HADS test be assessed for 2nd time at discharge & for 3rd time 4 weeks Post Surgery |
| Quality of Recovery Scale (QOR 40) |
1st baseline reading is obtained, outcome measures QOR 40 test be assessed for 2nd time at discharge & for 3rd time 4 weeks Post Surgery |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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 3 |
|
Date of First Enrollment (India)
|
02/09/2024 |
| 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="4"
Months="0"
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
|
Mind-body therapies such as mindfulness meditation (MM) are increasingly being studied and they seem to be offering multitudes of benefits. Since becoming popular in the 1970s, MM has been shown to improve psychological states such as anxiety and depression. The scope of MM has expanded in recent years, and MM has been shown to have positive effects on pain, recovery time, and even wound healing after surgery. Training patients in MM before surgery may be implemented at low cost and up to 24 hours before admission. Given these benefits, complementary mind-body therapies such as MM have potential to improve a patient’s surgical experience and outcomes.
Chest physiotherapy in the form of breathing exercises, secretion removal techniques etc and early bedside and out of bed ambulation are proven to be effective and are a part of the post op management protocol of standard physiotherapy or usual care routinely practiced everywhere. There have been studies done on effect of mindfulness meditation in Myocardial infarction patients, in patients with chronic pain , in patients with anxiety/depression and even in normal healthy individuals. There are a few studies done to check effect of MM on joint surgeries, oncology patients and gynecological surgeries. Few studies are found seeing effect of MM on acute post op pain. However there is paucity of literature in checking effect of MM in post elective CABG patients functional recovery. This study therefore aims to fill this gap by checking the effect of a holistic mind body intervention with standard physiotherapy in CABG patients in view of assessing the effect of a holistic intervention.
|