Effect of Mindfulness on Pain After Total Knee Arthroplasty

Opioid Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06118073
• Other study ID #: YFILL21P.1017
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 5, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: October 2023
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 140
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use
• Pain, Postoperative
• Post Operative Pain
• Total Knee Replacement

Intervention

Other:
• Headspace
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.

Procedure:
• Total Knee Replacement
Participant will have total knee replacement surgery

Locations

Country	Name	City	State
United States	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

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