Guided Meditation as an Adjunct to Enhance Postoperative Recovery

Not Applicable

Completed

• Conditions: Feasibility of a Meditation Program Perioperatively
• Interventions: Behavioral: Meditation

• Registration Number: NCT03198039
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-06-20
• Study First Submitted QC: 2017-06-22
• Study First Posted: 2017-06-23
• Study Start: 2017-11-28
• Primary Completion: 2020-04-30
• Study Completion: 2020-04-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-01
• Last Update Posted: 2024-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Group 1	Meditation	Meditation twice daily for at least two weeks prior to surgery and for four weeks after surgery
Group 2	Meditation	Meditation twice daily for four weeks after surgery

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.
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.
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.

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States