Guided Meditation as an Adjunct to Enhance Postoperative Recovery
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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 |
Outcome Measures
Primary Outcome Measures
- Adherence to implementing a meditation program in the perioperative period [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
- Cognitive function - MoCA [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.
- Pain scores [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.
- Total Opioid Consumption [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.
- Changes in Sleep - PSQI [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.
- Changes in Sleep - PROMIS [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.
- Biomarkers of inflammation [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18 years of age or older
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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
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Surgery scheduled for at least 14 days after enrollment
Exclusion Criteria:
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Urgent and/or emergent surgery
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Non-English speaking
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Cognitive impairment as defined by total MoCA score < 10
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Baseline DASS-21 depression score >10
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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
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History of cerebrovascular accident or recent history (< 3 months) of seizures
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History of dementia, Parkinson's disease, Alzheimer's disease, or other forms of cognitive decline
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Current use of cognition enhancing drugs
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Current management for chronic pain
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Currently enrolled in another interventional study that could impact the primary outcome, as determined by the PI
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Educational attainment below high school level or equivalent
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Significant visual impairment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beth Israel Deaconess Medical Center | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2017P000239