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Procedure

Mindfulness App for Post-Knee Surgery Pain

N/A

Waitlist Available

Research Sponsored by Rothman Institute Orthopaedics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with MDD who take medication for MDD and/or Patients with GAD who take medication for GAD

Patients undergoing unilateral primary TKA

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

Study Summary

This trial will evaluate whether using the app Headspace before/after knee replacement can improve outcomes, reduce pain & opioid use in those with anxiety/depression.

Who is the study for?

This trial is for individuals having a total knee replacement who also have depression or anxiety and are under treatment with medication or psychotherapy. They must own a smartphone to use the Headspace app but can't join if they're having both knees replaced, revision surgery, or using other mindfulness apps.Check my eligibility

What is being tested?

The study tests whether the Headspace app can improve recovery outcomes after knee surgery by reducing pain and lessening the need for opioid painkillers. Participants will be randomly assigned to either use Headspace or not as part of their post-surgery care.See study design

What are the potential side effects?

Since Headspace is a mindfulness app, it doesn't have physical side effects like medications do. However, users may experience emotional discomfort when learning new mindfulness techniques.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am taking medication for major depressive disorder (MDD) or generalized anxiety disorder (GAD).

Select...

I am having a knee replacement surgery on one knee.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Participant mental health

Participant satisfaction #1

Participant satisfaction #2

+1 more

Trial Design

2Treatment groups

Active Control

Group I: Total knee replacement with HeadspaceActive Control2 Interventions

Participants scheduled for primary total knee replacement will be randomized to receive the mindfulness intervention (a smartphone-based mindfulness application).

Group II: Total knee replacement without HeadspaceActive Control1 Intervention

Participants scheduled for primary total knee replacement will not receive the mindfulness intervention.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rothman Institute OrthopaedicsLead Sponsor

121 Previous Clinical Trials

21,438 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for this investigation still open?

"Clinicaltrials.gov lists this clinical trial as no longer actively recruiting participants, despite being initially posted on November 5th 2023 and recently edited on October 31st 2023. Fortunately, there are still 652 other trials seeking volunteers at the present time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of Mindfulness on Pain After Total Knee Arthroplasty

2023. "Effect of Mindfulness on Pain After Total Knee Arthroplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06118073.