Opioid Use, Post Operative Pain, Total Knee Replacement
Conditions
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.
Interventions
OTHERHeadspace
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.
PROCEDURETotal Knee Replacement
Participant will have total knee replacement surgery
Sponsors
Rothman Institute Orthopaedics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant mental health | 6 weeks | mental health will be tracked using the Headspace application after surgery |
| Postoperative pain | 6 weeks | postoperative pain will be measured using the Visual Analog Score (VAS) |
| Participant satisfaction #1 | 6 weeks | Participant satisfaction will be measured using the 12-Item Short Form (SF-12) questionnaire |
| Participant satisfaction #2 | 6 weeks | Participant satisfaction will be measured using the Knee Injury and Osteoarthritis Outcome Score (KOOS Jr.) questionnaire |
Countries
United States
Outcome results
None listed