Effect of Mindfulness on Pain After Total Knee Arthroplasty

NCT ID: NCT06118073

Last Updated: 2023-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-05

Study Completion Date

2024-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Total Knee Replacement Post Operative Pain Opioid Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Total knee replacement with Headspace

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

Group Type ACTIVE_COMPARATOR

Headspace

Intervention Type 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.

Total Knee Replacement

Intervention Type PROCEDURE

Participant will have total knee replacement surgery

Total knee replacement without Headspace

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

Group Type ACTIVE_COMPARATOR

Total Knee Replacement

Intervention Type PROCEDURE

Participant will have total knee replacement surgery

Interventions

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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.

Intervention Type OTHER

Total Knee Replacement

Participant will have total knee replacement surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rothman Institute Orthopaedics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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YFILL21P.1017

Identifier Type: -

Identifier Source: org_study_id

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