Effect of a Holistic Mind Body treatment in patients with Coronary Artery Bypass Graft surgery

Phase 3

Not yet recruiting

Conditions: Medical and Surgical,

Registration Number: CTRI/2023/10/059065

Lead Sponsor: Dr Shweta Manwadkar

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 patientâ€™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/depressionand 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 78

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1): K J Somaiya Hospital & Research Center
🇮🇳
Mumbai, MAHARASHTRA, India
K J Somaiya Hospital & Research Center
🇮🇳Mumbai, MAHARASHTRA, India
Dr Shweta Manwadkar
Principal investigator
8104017576
shweta@somaiya.edu