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Mindfulness Meditation Intervention Study

NCT06180486 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-02-02

No results posted yet for this study

Summary

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.

Conditions

  • Total Knee Replacement
  • Mediation
  • Feasibility

Interventions

OTHER

Mindfulness Meditation Intervention

The mindfulness intervention is a scripted, \~12min audio recording based on core tenets of mindfulness meditation and contextualized for patients undergoing total knee arthroplasty. It teaches sustained attention on the present, body awareness, acceptance of the body's current state, and transformational strategies to cope with emotional or physical stimuli as they arise. It has been created by the study team based on the teachings of Jon Kabat Zinn (founder of mindfulness meditation) and the PI's history teaching yoga and meditation. Patients will be encouraged to review the audio recording once a week.

Sponsors & Collaborators

  • Hospital for Special Surgery, New York

    lead OTHER

Principal Investigators

  • Christopher Li, MD · Hospital for Special Surgery, New York

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-02
Primary Completion
2025-01-28
Completion
2025-02-11

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06180486 on ClinicalTrials.gov