NCT06118073

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

November 5, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

November 7, 2023

Status Verified

October 1, 2023

Enrollment Period

1.1 years

First QC Date

October 31, 2023

Last Update Submit

October 31, 2023

Conditions

Total Knee ReplacementPost Operative PainOpioid Use

Outcome Measures

Primary Outcomes (4)

  • Postoperative pain

    postoperative pain will be measured using the Visual Analog Score (VAS)

    6 weeks

  • Participant satisfaction #1

    Participant satisfaction will be measured using the 12-Item Short Form (SF-12) questionnaire

    6 weeks

  • Participant satisfaction #2

    Participant satisfaction will be measured using the Knee Injury and Osteoarthritis Outcome Score (KOOS Jr.) questionnaire

    6 weeks

  • Participant mental health

    mental health will be tracked using the Headspace application after surgery

    6 weeks

Study Arms (2)

Total knee replacement with Headspace

ACTIVE COMPARATOR

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

Other: HeadspaceProcedure: Total Knee Replacement

Total knee replacement without Headspace

ACTIVE COMPARATOR

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

Procedure: Total Knee Replacement

Interventions

HeadspaceOTHER

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 with Headspace
Total Knee ReplacementPROCEDURE

Participant will have total knee replacement surgery

Total knee replacement with HeadspaceTotal knee replacement without Headspace

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2023

First Posted

November 7, 2023

Study Start

November 5, 2023

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

November 7, 2023

Record last verified: 2023-10

Locations

US(1)