Clinical trial NCT06180486: Mindfulness Meditation Intervention Study
Official title: Preoperative Mindfulness Meditation for Total Knee Arthroplasty: A Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Total Knee Replacement
Mediation
Feasibility
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2023-12-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial of two groups, intervention vs waitlist control
Primary purpose: OTHER

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 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.

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 randomized controlled trial. Mindfulness meditation is a practice well-known to psychology research based on sustained attention on the present and a non-judgment of one's current situation. It has been used for numerous psychological issues including stress, anxiety, and depression. This intervention group will be compared against a waitlist control group (patients will be told they are on a waitlist to receive the mindfulness intervention, which will occur after data collection has finished for their group). This control has been utilized in several mindfulness meditation studies.

Measures of anxiety, depression, resilience, pain and pain unpleasantness, and overall physical and mental health will be taken after randomization, but before the intervention (or being told they are on the waitlist). Overall physical and mental health measures will also be taken on the day of surgery and final surveys will be collected at 90 days post-op.

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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Overall mental health score
timeFrame: 1 week prior to surgery to post operative day 90
measure: Anxiety
timeFrame: 1 week prior to surgery to post operative day 90
measure: Depression
timeFrame: 1 week prior to surgery to post operative day 90
measure: Overall physical health scores
timeFrame: 1 week prior to surgery to post operative day 90
measure: Knee health
timeFrame: 1 week prior to surgery to pre operative holding
measure: MMI Practice Survey
timeFrame: pre-operative holding to post-operative day 90
measure: Exit Survey
timeFrame: pre-operative holding to post-operative day 90
Secondary outcomes:
measure: Pain outcomes of patients
timeFrame: 1 week prior to surgery to post operative day 90
measure: Numerical Rating Scale (NRS)
timeFrame: 1 week prior to surgery to post operative day 90
measure: Resilience training
timeFrame: 1 week prior to surgery to post operative day 90
measure: Patient satisfaction
timeFrame: Post operative day 14
measure: Pain catastrophizing scale
timeFrame: 1 week prior to surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Christopher Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
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