Clinical trial NCT03198039: Guided Meditation as an Adjunct to Enhance Postoperative Recovery
Official title: Guided Meditation as an Adjunct to Enhance Postoperative Recovery: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feasibility of a Meditation Program Perioperatively
Keywords: Meditation
Cognitive Dysfunction
Postoperative Period
Cardiac Surgery
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2017-06-23
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Adherence to implementing a meditation program in the perioperative period
timeFrame: Baseline through 1 month post surgery
Secondary outcomes:
measure: Cognitive function - MoCA
timeFrame: Baseline and hospital discharge (approximately 5 days)
measure: Pain scores
timeFrame: Postoperative Day 1 through hospital discharge (approximately 5 days)
measure: Total Opioid Consumption
timeFrame: Intraoperatively through 48 hours postoperatively
measure: Changes in Sleep - PSQI
timeFrame: Baseline and 1 month postoperatively
measure: Changes in Sleep - PROMIS
timeFrame: Baseline through 1 month postoperatively
measure: Biomarkers of inflammation
timeFrame: Baseline, preoperatively, and Day 2 postoperatively
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Balachundhar Subramaniam, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.