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Guided Meditation as an Adjunct to Enhance Postoperative Recovery

Beth Israel Lahey Health logo

Beth Israel Lahey Health

Status

Completed

Conditions

Feasibility of a Meditation Program Perioperatively

Treatments

Behavioral: Meditation

Study type

Interventional

Funder types

Other

Identifiers

NCT03198039
2017P000239

Details and patient eligibility

About

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

Full description

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.

Enrollment

29 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

29 participants in 3 patient groups

Group 1
Experimental group
Description:
Meditation twice daily for at least two weeks prior to surgery and for four weeks after surgery
Treatment:
Behavioral: Meditation
Group 2
Experimental group
Description:
Meditation twice daily for four weeks after surgery
Treatment:
Behavioral: Meditation
Group 3
No Intervention group
Description:
Control group - will undergo surgery and subsequent hospital stay according to the current standard of care, which does not include meditation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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