Mindfulness Meditation Intervention Study
Completed · Not applicable
Conditions studied: Total Knee Replacement, Mediation, Feasibility
In brief
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.
Key facts
- Study ID
- NCT06180486
- Run by
- Hospital for Special Surgery, New York
- People needed
- 30
- Starts
- 2024-02-02
- Expected to finish
- 2025-02-11
- Last updated by the study team
- 2026-02-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult patients undergoing primary total knee arthroplasty with a participating surgeon
- Patients on these medications for anxiety/depression: Fluoxetine, Paroxetine, Citalopram, Escitalopram, Sertraline, Fluvoxamine, Venlafaxine, Duloxetine, Levomilnacipran, Desvenlafaxine, Bupropion, Mirtazapine, Amitriptyline, Nortriptyline, Clonazepam, Alprazolam, Lorazepam, Diazepam, Oxazepam, Chlordiazepoxide
- Patients receiving intraoperative auricular acupuncture as part of participating surgeon's preferred anesthetic care
- Patients fluent in English
- ASA I-III
- BMI < 40
You may not qualify if…
- Patient not fluent in English (inability to understand the intervention video will likely affect ability to utilize the mindfulness techniques taught)
- Pediatric patients < 18 years of age
- Patients with contraindications to intra-op protocol
- Patients with contraindications to auricular acupuncture (non-native ear, active ear infection, gauges in the ears)
- Patients unable/unwilling to participate in the questionnaires or view the scripted intervention
- Patients scheduled for consecutive or staged surgeries
- Patients allergic to local anesthetics or study medications
- Patients who have kidney disease
Where it is running
- Hospital for Special Surgery — New York, New York, United States
Full record on ClinicalTrials.gov
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