Guided Meditation as an Adjunct to Enhance Postoperative Recovery
1 other identifier
interventional
29
1 country
1
Brief Summary
The primary purpose of this trial is to test the feasibility of implementing a meditation program in the perioperative period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2017
CompletedFirst Posted
Study publicly available on registry
June 23, 2017
CompletedStudy Start
First participant enrolled
November 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2020
CompletedJune 4, 2024
June 1, 2024
2.4 years
June 20, 2017
June 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Cognitive function - MoCA
Baseline and hospital discharge (approximately 5 days)
Pain scores
Postoperative Day 1 through hospital discharge (approximately 5 days)
Total Opioid Consumption
Intraoperatively through 48 hours postoperatively
Changes in Sleep - PSQI
Baseline and 1 month postoperatively
Changes in Sleep - PROMIS
Baseline through 1 month postoperatively
- +1 more secondary outcomes
Study Arms (3)
Group 1
EXPERIMENTALMeditation twice daily for at least two weeks prior to surgery and for four weeks after surgery
Group 2
EXPERIMENTALMeditation twice daily for four weeks after surgery
Group 3
NO INTERVENTIONControl group - will undergo surgery and subsequent hospital stay according to the current standard of care, which does not include meditation
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Educational attainment below high school level or equivalent
- Significant visual impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Related Publications (1)
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.
PMID: 30635064DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Balachundhar Subramaniam, MD, MPH
Beth Israel Deaconess Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 20, 2017
First Posted
June 23, 2017
Study Start
November 28, 2017
Primary Completion
April 30, 2020
Study Completion
April 30, 2020
Last Updated
June 4, 2024
Record last verified: 2024-06