Guided meditation as an adjunct to enhance postoperative recovery after cardiac surgery: study protocol for a prospective randomized controlled feasibility trial

Abstract

Background: Cardiac surgical procedures are associated with postoperative neurological complications such as cognitive decline and delirium, which can complicate recovery and impair quality of life. Perioperative depression and anxiety may be associated with increased mortality after cardiac surgeries. Surgical prehabilitation is an emerging concept that includes preoperative interventions to potentially reduce postoperative complications. While most current prehabilitation interventions focus on optimizing physical health, mind-body interventions are an area of growing interest. Preoperative mind-body interventions such as Isha Kriya meditation, may hold significant potential to improve postsurgical outcomes.

Methods: This is a prospective, randomized controlled feasibility trial. A total of 40 adult patients undergoing cardiac surgery will be randomized to one of three study groups. Participants randomized to either of the two intervention groups will receive meditative intervention: (1) commencing two weeks before surgery; or (2) commencing only from the day after surgery. Meditative intervention will last for four weeks after the surgery in these groups. Participants in the third control group will receive the current standard of care with no meditative intervention. All participants will undergo assessments using neurocognitive, sleep, depression, anxiety, and pain questionnaires at various time points in the perioperative period. Blood samples will be collected at baseline, preoperatively, and postoperatively to assess for inflammatory biomarkers. The primary aim of this trial is to assess the feasibility of implementing a perioperative meditative intervention program. Other objectives include studying the effect of meditation on postoperative pain, sleep, psychological wellbeing, cognitive function, and delirium. These will be used to calculate effect size to design future studies.

Discussion: This study serves as the first step towards understanding the feasibility of implementing a mind-body intervention as a prehabilitative intervention to improve postoperative surgical outcomes after cardiac surgery.

Trial registration: Clinicaltrials.gov, NCT03198039 . Registered on 23 June 2017.

Keywords: Cardiac surgery; Delirium; Depression, Anxiety, and Stress Scale (DASS-21); Isha Kriya; Meditation; Montreal Cognitive Assessment (MoCA); Patient-Reported Outcomes Measurement Information System (PROMIS) Surveys; Pittsburgh Sleep Quality Index (PSQI); Postoperative cognitive decline; Prehabilitation.

Conflict of interest statement

Ethics approval and consent to participate

This study has been approved by the Committee on Clinical Investigations Institutional Review Board at Beth Israel Deaconess Medical Center (Protocol 2017-P-000239). Written informed consent will be obtained from all individuals before initiation of study procedures.

Consent for publication

Not applicable.

Competing interests

The principal investigator, Dr. Balachundhar Subramaniam, is supported by the National Institutes of Health Research Project Grant GM 098406. Dr. Gloria Yeh was funded by the NIH National Center for Complementary and Integrative Health (K24 AT009465).

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Figures

Fig. 1

Meditation instructions. Participants in either mediation group are provided with the instructions depicted here. In short, this includes preparation and three stages in which the participant mindfully inhales and exhales slowly for 7 min, produces the sound “Ahh” seven times, and finishes with 5 min of being quiet

Fig. 2

SPIRIT figure. The schedule of enrolment, interventions, and assessments in the study