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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether practicing mindfulness meditation before knee replacement surgery can boost mental well-being and physical health afterward. Participants will be randomly divided into two groups: one will practice meditation before surgery, while the other will begin 90 days after. The goal is to determine if meditation aids resilience and recovery. This trial suits English-speaking adults scheduled for knee surgery who are currently taking medication for anxiety or depression. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance recovery experiences for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it includes patients who are on certain medications for anxiety and depression, so it seems likely you can continue those.

What prior data suggests that this mindfulness meditation intervention is safe for knee surgery patients?

Research has shown that mindfulness meditation is generally safe and well-tolerated. One study found that mindfulness practices can help reduce pain after surgery, with no serious side effects reported. Another study found that patients who practiced mindfulness before knee surgery had positive experiences. These findings suggest that mindfulness meditation could be a safe option to try before surgery. The current trial is investigating its benefits for knee surgery patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using mindfulness meditation for knee surgery because it offers a non-invasive way to support recovery. Unlike standard post-surgery treatments that often focus on medications for pain management and physical therapy, mindfulness meditation targets the mind-body connection, potentially reducing stress and anxiety before surgery. This mental preparation might enhance the body's healing process and improve overall surgical outcomes. By teaching patients mindfulness techniques, this approach aims to empower them with tools to manage pain and discomfort naturally.

What evidence suggests that mindfulness meditation is effective for improving post-knee surgery mental well-being or physical health?

Research has shown that practicing mindfulness meditation can reduce pain and improve mental health after surgery. One study found that mindfulness techniques significantly reduced pain following surgeries like total knee replacement. Another study suggested that mindfulness meditation can decrease anxiety and depression, which can influence recovery. In this trial, participants in the intervention group will receive the mindfulness meditation intervention (MMI) before their surgery day, potentially aiding in faster recovery and improved well-being. Meanwhile, the waitlist control group will receive MMI 90 days post-surgery. Although more research is needed, early results are promising for those undergoing knee surgery. ^{2 3 4 5 6}

Who Is on the Research Team?

Christopher Li, MD

Principal Investigator

Hospital for Special Surgery, New York

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10328720/

Mindfulness-Based Interventions for the Reduction of ... The aim of this systematic review and meta-analysis is to evaluate the effect of mindfulness-based interventions (MBIs) on post-surgical pain in patients ...

2. trialx.com trialx.com/clinical-trials/listings/293159/mindfulness-meditation-intervention-study/

Mindfulness Meditation Intervention Study This study will investigate the effect of a preoperative mindfulness meditation intervention (MMI) on outcomes for total knee arthroplasty (TKA) ...

3. rapm.bmj.com rapm.bmj.com/content/50/Suppl_1/A164.2

EP199 Preoperative mindfulness meditation for total knee ... Anxiety and depression are known to affect total knee arthroplasty (TKA) outcomes such as pain and mobility and may be mitigated by meditation. This pilot study ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03228745?term=AREA%5BBasicSearch%5D(MINDFULNESS%20BASED%20STRESS%20REDUCTION,%20MBSR)&rank=8

The Health Impact of Mindfulness Based Stress Reduction ... Despite surgical success of total knee arthroplasty (TKA), reports of dissatisfaction and poor outcomes including increased pain, reduced function for daily ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2773157X24001723

Mindfulness-based intervention for non-farmacological ... MBIs are associated with a significant reduction in postoperative pain following THA and TKA, representing a viable non-pharmacological option for pain ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06180486

NCT06180486 | Mindfulness Meditation Intervention Study 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 ...