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The primary purpose of this trial is to test the feasibility of implementing a meditation program in the perioperative period.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Meditation twice daily for at least two weeks prior to surgery and for four weeks after surgery |
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| Group 2 | Experimental | Meditation twice daily for four weeks after surgery |
|
| Group 3 | No Intervention | Control group - will undergo surgery and subsequent hospital stay according to the current standard of care, which does not include meditation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meditation | Behavioral | Isha Kriya (IK) meditation approximately 12 minutes, twice a day |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Balachundhar Subramaniam, MD, MPH | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30635064 | Derived | 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. |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D019122 | Meditation |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
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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 |
| D012064 |
| Relaxation Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |