Mindfulness Meditation for Knee Surgery

Overseen By Marko Popovic, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hospital for Special Surgery, New York

Must be taking: Antidepressants, Benzodiazepines

Disqualifiers: Non-English speakers, Kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this pilot study is to develop a randomized control trial study with sufficient power to definitely address if a preop mindfulness meditation intervention can improve post-total knee arthroplasty mental well-being or physical health compared to controls, and if a preop mindfulness meditation intervention can train resilience. The main questions it aims to answer are: 1. Is this preoperative mindfulness meditation study feasible at Hospital for Special Surgery? 2. Can we estimate a control and intervention group central tendency and variability to be used to determine sample size in future study? 3. Does a preoperative mindfulness meditation interventions improve post-total knee arthroplasty mental well-being or physical health compared to controls? Can preoperative a mindfulness meditation intervention train resilience (as measured by increased resilience score)? Participants will be randomly assigned to be in the intervention group or the waitlist control group. The intervention group gets the mindfulness mediation intervention prior to their day of surgery, and the control group will be given the mindfulness meditation intervention 90 days after their day of surgery. The waitlist control group allows for comparison between those who got the mindfulness meditation intervention prior to surgery and those who did not while still offering the potential benefits of the intervention after 90 days.

Research Team

Christopher Li, MD

Principal Investigator

Hospital for Special Surgery, New York

Eligibility Criteria

This trial is for adults undergoing knee replacement surgery who are not severely overweight, have a certain level of surgical risk (ASA I-III), and are getting specific anesthesia care. They must speak English and can be on certain anxiety/depression meds. It's not open to those with conditions that would exclude them from the study.

Inclusion Criteria

Patients fluent in English

I am an adult scheduled for a first-time knee replacement with a specific surgeon.

I am taking medication for anxiety or depression.

Exclusion Criteria

I am under 18 years old.

I am unable or unwilling to fill out questionnaires or view the intervention materials.

I am allergic to local anesthetics or medications used in this study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Mindfulness Meditation Intervention

Participants in the intervention group receive mindfulness meditation intervention 1 week prior to their day of surgery

1 week

1 visit (in-person)

Surgery and Immediate Postoperative Care

Participants undergo total knee arthroplasty and receive immediate postoperative care

1 day

1 visit (in-person)

Follow-up

Participants are monitored for mental and physical health outcomes, including anxiety, depression, and resilience, up to 90 days post-surgery

90 days

Multiple visits (in-person and virtual)

Waitlist Control Mindfulness Meditation Intervention

Participants in the waitlist control group receive mindfulness meditation intervention 90 days after their day of surgery

2 weeks

1 visit (in-person)

Treatment Details

Interventions

• Mindfulness Meditation Intervention

Trial Overview The study tests if mindfulness meditation before knee surgery can improve mental well-being or physical health afterward, compared to a control group. Participants will either receive the meditation intervention pre-surgery or be placed in a waitlist group to receive it after 90 days.

Participant Groups

Group I: Waitlist control: Receive MMI After 90 days Experimental Treatment 1 Intervention

The waitlist control group will allow for comparison of those who had access to the mindfulness meditation intervention (MMI) prior to surgery to those who did not. This group will be given the mindfulness meditation intervention 90 days after their surgery when all study questionnaires are complete. Up until 90-days, they will be asked the same questionnaires as the intervention group aside from the MMI practice survey and the exit survey. They will then be given the exit survey 2 weeks after receiving the MMI. This is done to ensure that both groups receive the potential benefit of the teachings and to deter patient dropout for those interested in the study because of wanting to receive the mindfulness training.

Group II: Intervention: Receive MMI before their day of surgery Experimental Treatment 1 Intervention

The intervention group will be given the mindfulness meditation intervention (MMI) 1 week prior to their day of surgery. Up until 90-days, they will be asked the same questionnaires as the waitlist control group, with the addition of the MMI practice survey and the exit survey.

Who Is Running the Clinical Trial?

Hospital for Special Surgery, New York

Lead Sponsor

Trials

257

Recruited

61,800+