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Clinical Trials/NCT03198039
NCT03198039
Completed
Not Applicable

Guided Meditation as an Adjunct to Enhance Postoperative Recovery: A Feasibility Study

Beth Israel Deaconess Medical Center1 site in 1 country29 target enrollmentNovember 28, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Feasibility of a Meditation Program Perioperatively
Sponsor
Beth Israel Deaconess Medical Center
Enrollment
29
Locations
1
Primary Endpoint
Adherence to implementing a meditation program in the perioperative period
Status
Completed
Last Updated
last year

Overview

Brief Summary

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

Detailed 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.

Registry
clinicaltrials.gov
Start Date
November 28, 2017
End Date
April 30, 2020
Last Updated
last year
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Balachundhar Subramaniam

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

Inclusion Criteria

  • 18 years of age or older
  • 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
  • Surgery scheduled for at least 14 days after enrollment

Exclusion Criteria

  • Urgent and/or emergent surgery
  • Non-English speaking
  • Cognitive impairment as defined by total MoCA score \< 10
  • Baseline DASS-21 depression score \>10
  • 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
  • History of cerebrovascular accident or recent history (\< 3 months) of seizures
  • History of dementia, Parkinson's disease, Alzheimer's disease, or other forms of cognitive decline
  • Current use of cognition enhancing drugs
  • Current management for chronic pain
  • Currently enrolled in another interventional study that could impact the primary outcome, as determined by the PI

Outcomes

Primary Outcomes

Adherence to implementing a meditation program in the perioperative period

Time Frame: Baseline through 1 month post surgery

In this descriptive, feasibility study, evaluation of feasibility will include adherence to meditation intervention (total number of sessions completed).

Secondary Outcomes

  • Cognitive function - MoCA(Baseline and hospital discharge (approximately 5 days))
  • Total Opioid Consumption(Intraoperatively through 48 hours postoperatively)
  • Changes in Sleep - PSQI(Baseline and 1 month postoperatively)
  • Biomarkers of inflammation(Baseline, preoperatively, and Day 2 postoperatively)
  • Pain scores(Postoperative Day 1 through hospital discharge (approximately 5 days))
  • Changes in Sleep - PROMIS(Baseline through 1 month postoperatively)

Study Sites (1)

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