Effect of Mindfulness on Pain After Total Knee Arthroplasty

Not Applicable

• Conditions: Opioid Use; Total Knee Replacement; Post Operative Pain
• Interventions: Other: Headspace; Procedure: Total Knee Replacement

• Registration Number: NCT06118073
• Lead Sponsor: Rothman Institute Orthopaedics

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-31
• Study First Submitted QC: 2023-10-31
• Last Update Submitted: 2023-10-31
• Study Start: 2023-11-05
• Study First Posted: 2023-11-07
• Last Update Posted: 2023-11-07
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Total knee replacement with Headspace	Headspace	Participants scheduled for primary total knee replacement will be randomized to receive the mindfulness intervention (a smartphone-based mindfulness application).
Total knee replacement with Headspace	Total Knee Replacement	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	Total Knee Replacement	Participants scheduled for primary total knee replacement will not receive the mindfulness intervention.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Rothman Orthopaedic Institute; 🇺🇸 Philadelphia, Pennsylvania, United States