Guided Meditation as an Adjunct to Enhance Postoperative Recovery

Feasibility of a Meditation Program Perioperatively Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03198039
• Other study ID #: 2017P000239
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 28, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 31, 2023
• 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

Related Conditions & MeSH terms

• Feasibility of a Meditation Program Perioperatively

Intervention

Behavioral:
• Meditation
Isha Kriya (IK) meditation approximately 12 minutes, twice a day

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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