Skip to main content
OpenTrials
Completed

NCT Number: NCT03198039

Guided Meditation as an Adjunct to Enhance Postoperative Recovery

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Feasibility of a Meditation Program Perioperatively Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meditation

Behavioral

Isha Kriya (IK) meditation approximately 12 minutes, twice a day

Primary outcomes

  1. Adherence to implementing a meditation program in the perioperative period

    Time frame: 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 outcomes

  1. Cognitive function - MoCA

    Time frame: 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.

  2. Pain scores

    Time frame: 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.

  3. Total Opioid Consumption

    Time frame: 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.

  4. Changes in Sleep - PSQI

    Time frame: 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.

  5. Changes in Sleep - PROMIS

    Time frame: 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.

  6. Biomarkers of inflammation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 23, 2017
Registry last updated
Jun 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.