Effect of Mindfulness on Pain After Total Knee Arthroplasty

Study Overview
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Brief Summary
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This study will be a prospective randomized controlled trial evaluating the effectiveness of using Headspace before and after undergoing total knee replacement surgery. The purpose of this study will be to determine whether using Headspace will help to improve functional outcome scores, decrease pain, and decrease opioid medication use after total knee replacement in patients with depression and/or anxiety. Headspace is a smartphone-based application that guides individuals through various mindfulness sessions and has been shown to reduce symptoms of depression, anxiety, and pain.

Official Title
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The Effect of Utilizing Mindfulness Perioperatively on Pain, Opioid Consumption, and Functional Outcomes in Patients With Depression and Anxiety Undergoing Total Knee Arthroplasty: A Randomized Clinical Trial

Conditions
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Post Operative Pain, Opioid Use, Total Knee Replacement

Intervention / Treatment
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* Other: Headspace
* Procedure: Total Knee Replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing unilateral primary TKA AND Patients with MDD who take medication for MDD and/or Patients with GAD who take medication for GAD Patients with MDD and/or Patients with GAD who are being treated for those conditions with psychotherapy by a psychologist or psychiatrist Patients with an SF-12 Mental Health Score less than 45.6 Owning a smartphone (Apple or Android) to be able to download the mindfulness application Exclusion Criteria: Patients undergoing bilateral TKA Patients undergoing revision TKA Patients with mental health conditions other than MDD and/or GAD Patients currently utilizing a mindfulness application

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Total knee replacement with Headspace<br>Participants scheduled for primary total knee replacement will be randomized to receive the mindfulness intervention (a smartphone-based mindfulness application). | Other: Headspace<br>* Headspace is a smartphone-based application that guides individuals through various mindfulness sessions and has been shown to reduce symptoms of depression, anxiety, and pain. Participants will be required to answer questions regarding anxiety levels and pain for 6 weeks after surgery.<br>Procedure: Total Knee Replacement<br>* Participant will have total knee replacement surgery<br>|
| Active Comparator: Total knee replacement without Headspace<br>Participants scheduled for primary total knee replacement will not receive the mindfulness intervention. | Procedure: Total Knee Replacement<br>* Participant will have total knee replacement surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | postoperative pain will be measured using the Visual Analog Score (VAS) | 6 weeks | 
| Participant satisfaction #1 | Participant satisfaction will be measured using the 12-Item Short Form (SF-12) questionnaire | 6 weeks | 
| Participant satisfaction #2 | Participant satisfaction will be measured using the Knee Injury and Osteoarthritis Outcome Score (KOOS Jr.) questionnaire | 6 weeks | 
| Participant mental health | mental health will be tracked using the Headspace application after surgery | 6 weeks |