Guided Meditation as an Adjunct to Enhance Postoperative Recovery

NCT ID: NCT03198039

Last Updated: 2024-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-28

Study Completion Date

2020-04-30

Brief Summary

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The primary purpose of this trial is to test the feasibility of implementing a meditation program in the perioperative period.

Detailed Description

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This is a prospective, randomized, controlled study involving 30 adult patients undergoing cardiac surgery. Investigators will test the feasibility of implementing a meditation program in the perioperative period. Patients will be randomized to one of three groups: those who complete Isha Kriya (IK) meditation before and after surgery, those who complete postoperative IK meditation only, and those who receive the standard of care with no meditation intervention. In addition to testing feasibility, the investigators will explore whether a meditation program can affect recovery after surgery. Patients enrolled will be followed postoperatively for up to one month to assess their cognitive function, pain, and sleep. Blood will also be collected for analysis of biomarkers of inflammation.

Conditions

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Feasibility of a Meditation Program Perioperatively

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group 1

Meditation twice daily for at least two weeks prior to surgery and for four weeks after surgery

Group Type EXPERIMENTAL

Meditation

Intervention Type BEHAVIORAL

Isha Kriya (IK) meditation approximately 12 minutes, twice a day

Group 2

Meditation twice daily for four weeks after surgery

Group Type EXPERIMENTAL

Meditation

Intervention Type BEHAVIORAL

Isha Kriya (IK) meditation approximately 12 minutes, twice a day

Group 3

Control group - will undergo surgery and subsequent hospital stay according to the current standard of care, which does not include meditation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Meditation

Isha Kriya (IK) meditation approximately 12 minutes, twice a day

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. 18 years of age or older
2. Undergoing any of the following types of cardiac surgery: CABG with or without valve surgery (aortic and/or mitral); isolated valve surgery; isolated aortic surgery
3. Surgery scheduled for at least 14 days after enrollment

Exclusion Criteria

1. Urgent and/or emergent surgery
2. Non-English speaking
3. Cognitive impairment as defined by total MoCA score \< 10
4. Baseline DASS-21 depression score \>10
5. Pre-existing history of psychiatric illness as documented in the medical record or divulged in history taking in pre-enrollment patient interview, such as anxiety, depression, or bipolar disorder
6. History of cerebrovascular accident or recent history (\< 3 months) of seizures
7. History of dementia, Parkinson's disease, Alzheimer's disease, or other forms of cognitive decline
8. Current use of cognition enhancing drugs
9. Current management for chronic pain
10. Currently enrolled in another interventional study that could impact the primary outcome, as determined by the PI
11. Educational attainment below high school level or equivalent
12. Significant visual impairment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Balachundhar Subramaniam

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Balachundhar Subramaniam, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Packiasabapathy S, Susheela AT, Mueller A, Patxot M, Gasangwa DV, O'Gara B, Shaefi S, Marcantonio ER, Yeh GY, Subramaniam B. Guided meditation as an adjunct to enhance postoperative recovery after cardiac surgery: study protocol for a prospective randomized controlled feasibility trial. Trials. 2019 Jan 11;20(1):39. doi: 10.1186/s13063-018-3103-8.

Reference Type DERIVED
PMID: 30635064 (View on PubMed)

Other Identifiers

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2017P000239

Identifier Type: -

Identifier Source: org_study_id

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