Feasibility of a Meditation Program Perioperatively Clinical Trial
Official title:
Guided Meditation as an Adjunct to Enhance Postoperative Recovery: A Feasibility Study
| Verified date | June 2024 |
| Source | Beth Israel Deaconess Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The primary purpose of this trial is to test the feasibility of implementing a meditation program in the perioperative period.
| Status | Completed |
| Enrollment | 29 |
| Est. completion date | April 30, 2020 |
| Est. primary completion date | April 30, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Beth Israel Deaconess Medical Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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) | |
| Secondary | 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) | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |