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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Total Knee Replacement
- Sponsor
- Rothman Institute Orthopaedics
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Participant satisfaction #1
- Status
- Enrolling By Invitation
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients undergoing unilateral primary TKA
- •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
Outcomes
Primary Outcomes
Participant satisfaction #1
Time Frame: 6 weeks
Participant satisfaction will be measured using the 12-Item Short Form (SF-12) questionnaire
Postoperative pain
Time Frame: 6 weeks
postoperative pain will be measured using the Visual Analog Score (VAS)
Participant mental health
Time Frame: 6 weeks
mental health will be tracked using the Headspace application after surgery
Participant satisfaction #2
Time Frame: 6 weeks
Participant satisfaction will be measured using the Knee Injury and Osteoarthritis Outcome Score (KOOS Jr.) questionnaire