Guided Meditation as an Adjunct to Enhance Postoperative Recovery

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Feasibility of a Meditation Program Perioperatively
• Intervention / Treatment: Behavioral: Meditation

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
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to implementing a meditation program in the perioperative period	In this descriptive, feasibility study, evaluation of feasibility will include adherence to meditation intervention (total number of sessions completed).	Baseline through 1 month post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive function - MoCA	The Montreal Cognitive Assessment (MoCA) will be administered at baseline and hospital discharge. This is a validated test that measures cognitive impairment.	Baseline and hospital discharge (approximately 5 days)
Pain scores	Postoperative pain will be assessed with a standard 11-point scale. Pain scores will be obtained by asking the subject.	Postoperative Day 1 through hospital discharge (approximately 5 days)
Total Opioid Consumption	The total opioid dosage received in the intraoperative period and the first 48 hours postoperatively will be abstracted from the medical record.	Intraoperatively through 48 hours postoperatively
Changes in Sleep - PSQI	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.	Baseline and 1 month postoperatively
Changes in Sleep - PROMIS	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.	Baseline through 1 month postoperatively
Biomarkers of inflammation	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.	Baseline, preoperatively, and Day 2 postoperatively

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2017
• Primary Completion (Actual): April 30, 2020
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: June 20, 2017
• First Submitted That Met QC Criteria: June 22, 2017
• First Posted (Actual): June 23, 2017

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Meditation; Cardiac Surgery; Cognitive Dysfunction; Postoperative Period
• Other Study ID Numbers: 2017P000239

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No