Mindfulness Meditation Intervention Study

Hospital for Special Surgery (HSS)

Status: Completed

Conditions: Mediation; Feasibility; Total Knee Replacement

Treatments: Other: Mindfulness Meditation Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06180486

2023-2131

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Waitlist control: Receive MMI After 90 days

Other group

Description:

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.

Treatment:

Other: Mindfulness Meditation Intervention

Intervention: Receive MMI before their day of surgery

Experimental group

Description:

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.

Treatment:

Other: Mindfulness Meditation Intervention