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Behavioural Intervention

Waitlist control: Receive MMI After 90 days for Total Knee Arthroplasty

N/A

Recruiting

Led By Christopher Li, MD

Research Sponsored by Hospital for Special Surgery, New York

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult patients undergoing primary total knee arthroplasty with a participating surgeon

Patients on specific medications for anxiety/depression

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 week prior to surgery to post operative day 90

Awards & highlights

Study Summary

This trial aims to see if mindfulness meditation before knee surgery can improve mental and physical health compared to those who did not meditate. Participants will either meditate before surgery or wait 90 days post-s

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Mindfulness meditation is generally considered safe with minimal risks. However, some individuals may experience increased emotional distress when confronting difficult thoughts or feelings during practice.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am taking medication for anxiety or depression.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 week prior to surgery to post operative day 90

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 week prior to surgery to post operative day 90

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week prior to surgery to post operative day 90 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Anxiety

Depression

Exit Survey

+4 more

Secondary outcome measures

Numerical Rating Scale (NRS)

Pain catastrophizing scale

Pain outcomes of patients

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Waitlist control: Receive MMI After 90 daysExperimental Treatment1 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 surgeryExperimental Treatment1 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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hospital for Special Surgery, New YorkLead Sponsor

243 Previous Clinical Trials

59,300 Total Patients Enrolled

Christopher Li, MDPrincipal InvestigatorHospital for Special Surgery, New York

1 Previous Clinical Trials

5,000 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment process currently open for this research study?

"As per clinicaltrials.gov, this ongoing trial is actively seeking participants. It was first listed on 2/2/2024 and last modified on 2/26/2024."

Answered by AI

What is the current capacity for patient enrollment in this clinical trial?

"Indeed, the details on clinicaltrials.gov confirm that patient recruitment is underway for this study. Originally appearing on February 2nd, 2024, with the latest update made on February 26th, 2024. The trial seeks to enroll 30 participants from a single site."

Answered by AI

What are the anticipated results that this research aims to achieve?

"The main goal of this research is to gauge the MMI Practice Survey from 1 week before surgery until postoperative day 90. Secondary objectives encompass assessing pain levels in the operative knee using a Numerical Rating Scale (NRS) on various time points, evaluating resilience through the Brief Resilience Scale at different intervals, and measuring patient satisfaction via a survey following total knee replacement surgery."

Answered by AI

Recent research and studies

The Journal of RheumatologyJournal

Rates of Total Joint Replacement in the United States: Future Projections to 2020–2040 Using the National Inpatient Sample

Singh, Jasvinder A., Shaohua Yu, Lang Chen, and John D. Cleveland. 2019. “Rates of Total Joint Replacement in the United States: Future Projections to 2020–2040 Using the National Inpatient Sample”. The Journal of Rheumatology. The Journal of Rheumatology. doi:10.3899/jrheum.170990.

clinicaltrials.govStudy

Mindfulness Meditation Intervention Study

2024. "Mindfulness Meditation Intervention Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06180486.