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Trial record 3 of 6 for:    Balachundhar Subramaniam

Guided Meditation as an Adjunct to Enhance Postoperative Recovery

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ClinicalTrials.gov Identifier: NCT03198039
Recruitment Status : Recruiting
First Posted : June 23, 2017
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Balachundhar Subramaniam, Beth Israel Deaconess Medical Center

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

Condition or disease Intervention/treatment Phase
Feasibility of a Meditation Program Perioperatively Behavioral: Meditation Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Guided Meditation as an Adjunct to Enhance Postoperative Recovery: A Feasibility Study
Actual Study Start Date : November 28, 2017
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: Group 1
Meditation twice daily for at least two weeks prior to surgery and for four weeks after surgery
Behavioral: Meditation
Isha Kriya (IK) meditation approximately 12 minutes, twice a day

Experimental: Group 2
Meditation twice daily for four weeks after surgery
Behavioral: Meditation
Isha Kriya (IK) meditation approximately 12 minutes, twice a day

No Intervention: Group 3
Control group - will undergo surgery and subsequent hospital stay according to the current standard of care, which does not include meditation



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Cognitive function - MoCA [ Time Frame: Baseline and hospital discharge (approximately 5 days) ]
    The Montreal Cognitive Assessment (MoCA) will be administered at baseline and hospital discharge. This is a validated test that measures cognitive impairment.

  2. Pain scores [ Time Frame: Postoperative Day 1 through hospital discharge (approximately 5 days) ]
    Postoperative pain will be assessed with a standard 11-point scale. Pain scores will be obtained by asking the subject.

  3. Total Opioid Consumption [ Time Frame: Intraoperatively through 48 hours postoperatively ]
    The total opioid dosage received in the intraoperative period and the first 48 hours postoperatively will be abstracted from the medical record.

  4. Changes in Sleep - PSQI [ Time Frame: Baseline and 1 month postoperatively ]
    Changes in sleep will be measured by the Pittsburgh Sleep Quality Index (PSQI) which measures quality and patterns of sleep during the past month. This will be completed at baseline and 1 month postoperatively.

  5. Changes in Sleep - PROMIS [ Time Frame: Baseline through 1 month postoperatively ]
    Changes in sleep will be measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance and Sleep Related Impairment questionnaires. The PROMIS sleep questionnaires assess self-reported perceptions of sleep quality and sleep impairment and will be completed weekly from baseline through 1 month postoperatively.

  6. Biomarkers of inflammation [ Time Frame: Baseline, preoperatively, and Day 2 postoperatively ]
    Blood will be collected at baseline and on postoperative Day 2 to investigate whether the use of a meditation regimen results in a reduction in inflammation and stress secondary to surgery. Subjects randomized to meditation before surgery will also have blood collected preoperatively. Specimens will be frozen for analysis at a later date.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198039


Contacts
Contact: Balachundhar Subramaniam, MD, MPH 617-667-2721 bsubrama@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Balachundhar Subramaniam, MD, MPH Beth Israel Deaconess Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Balachundhar Subramaniam, Principal Investigator, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03198039     History of Changes
Other Study ID Numbers: 2017P000239
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Balachundhar Subramaniam, Beth Israel Deaconess Medical Center:
Meditation
Cognitive Dysfunction
Postoperative Period
Cardiac Surgery