The Effect of Mindfulness Training Before Primary Total Joint Arthroplasty on Sleep Quality

July 7, 2023 updated by: Jason Jennings, Colorado Joint Replacement
The primary purpose of this study is the determine whether a 15 minute Mindfulness Meditation (MM) administered at the preoperative appointment prior to primary unilateral total joint arthroplasty (TJA) results in any improvement in Pittsburg Sleep Quality Index (PSQI) score, a validated metric for sleep quality, at 2, 6 or 12 weeks post-operatively.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary purpose of this study is the determine whether a 15 minute Mindfulness Meditation (MM) administered at the preoperative appointment prior to primary unilateral total joint arthroplasty (TJA) results in any improvement in Pittsburg Sleep Quality Index (PSQI) score, a validated metric for sleep quality, at 2, 6 or 12 weeks post-operatively. We hypothesize that patients in the MM cohort will have lower PSQI scores, indicating higher sleep quality, at both post-operative time points. Secondary aims include characterizing differences between cohorts in Visual Analog Scale (VAS) for pain, Epworth Sleepiness Scale (ESS) scores, Patient Reported Outcome Measurement Information System - Sleep Disturbance - Short Form, and Knee Injury and Osteoarthritis Outcome Scores (KOOS) at 2, 6 and 12 weeks following TJA.

Study Type

Interventional

Enrollment (Estimated)

282

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80210
        • Recruiting
        • Colorado Joint Replacement
        • Contact:
        • Principal Investigator:
          • Jason Jennings, MD
        • Sub-Investigator:
          • Douglas Dennis, MD
        • Sub-Investigator:
          • Todd Miner, MD
        • Sub-Investigator:
          • Jessica Phillips, MD
        • Sub-Investigator:
          • Hayley Ennis, MD
        • Sub-Investigator:
          • Charlie Yang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients undergoing primary unilateral total joint arthroplasty at Colorado Joint Replacement
  • Between the ages of 18 and 90 years old will be included in the study.

Exclusion Criteria:

  • Simultaneous total joint arthroplasty
  • Uni-compartmental knee arthroplasty
  • Revision surgery for infection, fracture or other indication.
  • History of Drug or Alcohol Abuse
  • Patients who are unable to present at a standard pre-operative appointment within 4 weeks prior to scheduled surgery will also be excluded, as the MM intervention would not be possible to administer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No Treatment
Patient will receive no mindfulness meditation training.
Experimental: Mindfulness at Pre-Op
Patient will receive a one time training at their pre-operative appointment.
Behavioral: Mindfulness Meditation Training
Patient will watch a 10 minute video on how to use mindfulness meditation to help with sleep after a total joint replacement procedure.
Experimental: Multiple Mindfulness Meditation
Mindfulness Video Training at Pre-Op, 1 Day Prior to surgery, 3 day's Post OP and 2 Weeks Post OP.
Behavioral: Mindfulness Meditation Training
Patient will watch a 10 minute video on how to use mindfulness meditation to help with sleep after a total joint replacement procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pittsburg Sleep Quality Index score
Time Frame: Change from Pre-Op to 2, 6 and 12 weeks post op.
Improvement in Pittsburg Sleep Quality Index (PSQI) score, Scale is 0 to 21, higher score is worse outcome.
Change from Pre-Op to 2, 6 and 12 weeks post op.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Score
Time Frame: Change from Pre-Op to 2, 6 and 12 weeks post op.
Improvement in Visual Analog Score (VAS), Scale is 1 to 10, higher score is worse outcome
Change from Pre-Op to 2, 6 and 12 weeks post op.
Epworth Sleepiness Scale
Time Frame: Change from Pre-Op to 2, 6 and 12 weeks post op.
Improvement in Epworth Sleepiness Scale (ESS), Scale is 0 to 24, higher score is worse outcome
Change from Pre-Op to 2, 6 and 12 weeks post op.
Knee Injury and Osteoarthritis Outcome Scores JR
Time Frame: Change from Pre-Op to 2, 6 and 12 weeks post op.
Improvement in Knee Injury and Osteoarthritis Outcome Scores JR (KOOS JR), Scale is 1 to 100, lower score is worse outcome
Change from Pre-Op to 2, 6 and 12 weeks post op.
Knee Society Score (KSS)
Time Frame: Change from Pre-Op to 6 Weeks post op.
Improvement in Knee Society Score (KSS), Scale is 0 to 100, lower score is worse outcome
Change from Pre-Op to 6 Weeks post op.
Patient Reported Outcome Measurement Information System - Sleep Disturbance (PROMIS-SD)
Time Frame: Change from Pre-Op to 2, 6 and 12 weeks post op.
Improvement in Patient Reported Outcome Measurement Information System - Sleep Disturbance (PROMIS-SD), Scale is 8 to 40, higher score is worse outcome
Change from Pre-Op to 2, 6 and 12 weeks post op.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colorado Joint Replacement

Investigators

  • Principal Investigator: Jason M Jennings, MD, DPT, Colorado Joint Replacement

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2022

Primary Completion (Estimated)

March 15, 2024

Study Completion (Estimated)

July 31, 2024

Study Registration Dates

First Submitted

March 15, 2022

First Submitted That Met QC Criteria

March 15, 2022

First Posted (Actual)

March 24, 2022

Study Record Updates

Last Update Posted (Actual)

July 10, 2023

Last Update Submitted That Met QC Criteria

July 7, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1845025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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