Status:

ACTIVE_NOT_RECRUITING

Mindfulness Meditation Intervention Study

Lead Sponsor:

Hospital for Special Surgery, New York

Conditions:

Total Knee Replacement

Mediation

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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 arthr...

Detailed Description

This study will investigate the effect of a preoperative mindfulness meditation intervention (MMI) on outcomes for total knee arthroplasty (TKA) patients at the Hospital for Special Surgery in a rando...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

February 2 2024

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 11 2025

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT06180486

Start Date

February 2 2024

End Date

February 11 2025

Last Update

December 27 2024

Active Locations (1)

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1

Hospital for Special Surgery

New York, New York, United States, 10021