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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total knee replacement with Headspace | Active Comparator | Participants scheduled for primary total knee replacement will be randomized to receive the mindfulness intervention (a smartphone-based mindfulness application). |
|
| Total knee replacement without Headspace | Active Comparator | Participants scheduled for primary total knee replacement will not receive the mindfulness intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Headspace | Other | 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. |
| 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 |
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Inclusion Criteria:
AND
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rothman Orthopaedic Institute | Philadelphia | Pennsylvania | 19107 | United States |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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| Total Knee Replacement | Procedure | Participant will have total knee replacement surgery |
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |