Effect of Mindfulness on Pain After Total Knee Arthroplasty
Launched by ROTHMAN INSTITUTE ORTHOPAEDICS · Oct 31, 2023
Trial Information
Current as of November 12, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
This study is checking whether using the Headspace mindfulness app around the time of total knee replacement can help people do better after surgery. Specifically, researchers want to see if mindfulness training before and after the operation can lower pain after surgery, improve overall knee function and mood, and reduce the need for opioid pain medicines in people who also have depression or anxiety. Participants are randomly assigned to either have the knee replacement with Headspace or the knee replacement without Headspace, and the main checks happen about 6 weeks after surgery.
Who can join: adults (18+) having a first-time, unilateral total knee replacement and who have depression and/or anxiety that’s being treated (medication and/or psychotherapy) and who have a SF-12 Mental Health score below 45.6. You must own a smartphone to use Headspace and not currently be using a mindfulness app. Key exclusions include having both knees replaced at once or needing a revision surgery, and not having other mental health conditions beyond depression or anxiety. The study is being conducted at the Rothman Institute in Philadelphia, is randomized and open-label (no blinding), and plans to enroll about 140 participants. There are currently no results yet.
Gender
ALL
Eligibility criteria
- 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
About Rothman Institute Orthopaedics
Rothman Institute Orthopaedics is a leading healthcare organization specializing in orthopedic care and research. With a commitment to advancing the field of orthopedics, Rothman Institute conducts innovative clinical trials aimed at improving patient outcomes and enhancing treatment methodologies. Renowned for its team of highly skilled orthopedic surgeons and researchers, the institute integrates cutting-edge technology and evidence-based practices to deliver exceptional care. Through its rigorous research initiatives, Rothman Institute is dedicated to fostering advancements in orthopedic medicine and contributing to the overall improvement of musculoskeletal health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Philadelphia, Pennsylvania, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported