Effect of Mindfulness on Pain After Total Knee Arthroplasty

Sponsor

Rothman Institute Orthopaedics (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT06118073

Collaborator

(none)

140

Enrollment

Location

Arms

12.8

Anticipated Duration (Months)

10.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Total Knee Replacement Post Operative Pain Opioid Use	Other: Headspace Procedure: Total Knee Replacement	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Anticipated Study Start Date :

Nov 5, 2023

Anticipated Primary Completion Date :

Nov 30, 2024

Anticipated Study Completion Date :

Nov 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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).	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
Active Comparator: Total knee replacement without Headspace Participants scheduled for primary total knee replacement will not receive the mindfulness intervention.	Procedure: Total Knee Replacement Participant will have total knee replacement surgery

Arm

Intervention/Treatment

Active Comparator: 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).

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

Active Comparator: Total knee replacement without Headspace

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

Procedure: Total Knee Replacement

Participant will have total knee replacement surgery

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

Rothman Institute Orthopaedics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rothman Institute Orthopaedics

ClinicalTrials.gov Identifier:

NCT06118073

Other Study ID Numbers:

YFILL21P.1017

First Posted:

Nov 7, 2023

Last Update Posted:

Nov 7, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Nov 7, 2023