Guided Meditation as an Adjunct to Enhance Postoperative Recovery

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

Detailed Description
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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.

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

Conditions
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Feasibility of a Meditation Program Perioperatively

Intervention / Treatment
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* Behavioral: Meditation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Meditation twice daily for at least two weeks prior to surgery and for four weeks after surgery | Behavioral: Meditation<br>* Isha Kriya (IK) meditation approximately 12 minutes, twice a day<br>|
| Experimental: Group 2<br>Meditation twice daily for four weeks after surgery | Behavioral: Meditation<br>* Isha Kriya (IK) meditation approximately 12 minutes, twice a day<br>|
| No Intervention: Group 3<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meditation, Cognitive Dysfunction, Postoperative Period, Cardiac Surgery