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

Primary Purpose

Sleep Disturbance, Arthropathy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Meditation Training
Sponsored by
Colorado Joint Replacement
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disturbance

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Colorado Joint ReplacementRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

No Treatment

Mindfulness at Pre-Op

Multiple Mindfulness Meditation

Arm Description

Patient will receive no mindfulness meditation training.

Patient will receive a one time training at their pre-operative appointment.

Mindfulness Video Training at Pre-Op, 1 Day Prior to surgery, 3 day's Post OP and 2 Weeks Post OP.

Outcomes

Primary Outcome Measures

Pittsburg Sleep Quality Index score
Improvement in Pittsburg Sleep Quality Index (PSQI) score, Scale is 0 to 21, higher score is worse outcome.

Secondary Outcome Measures

Visual Analog Score
Improvement in Visual Analog Score (VAS), Scale is 1 to 10, higher score is worse outcome
Epworth Sleepiness Scale
Improvement in Epworth Sleepiness Scale (ESS), Scale is 0 to 24, higher score is worse outcome
Knee Injury and Osteoarthritis Outcome Scores JR
Improvement in Knee Injury and Osteoarthritis Outcome Scores JR (KOOS JR), Scale is 1 to 100, lower score is worse outcome
Knee Society Score (KSS)
Improvement in Knee Society Score (KSS), Scale is 0 to 100, lower score is worse outcome
Patient Reported Outcome Measurement Information System - Sleep Disturbance (PROMIS-SD)
Improvement in Patient Reported Outcome Measurement Information System - Sleep Disturbance (PROMIS-SD), Scale is 8 to 40, higher score is worse outcome

Full Information

First Posted
March 15, 2022
Last Updated
July 7, 2023
Sponsor
Colorado Joint Replacement
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1. Study Identification

Unique Protocol Identification Number
NCT05295004
Brief Title
The Effect of Mindfulness Training Before Primary Total Joint Arthroplasty on Sleep Quality
Official Title
The Effect of Mindfulness Training Before Primary Total Joint Arthroplasty on Sleep Quality
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
March 15, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Colorado Joint Replacement

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disturbance, Arthropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomize à Arm 1 (No Treatment), Arm 2 (Mindfulness Video @ Pre-Op), Arm 3 (Mindfulness Video @ Pre-Op, 1 Day Prior to surgery, 3 day's Post OP, 2 Weeks Post OP)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
282 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No Treatment
Arm Type
No Intervention
Arm Description
Patient will receive no mindfulness meditation training.
Arm Title
Mindfulness at Pre-Op
Arm Type
Experimental
Arm Description
Patient will receive a one time training at their pre-operative appointment.
Arm Title
Multiple Mindfulness Meditation
Arm Type
Experimental
Arm Description
Mindfulness Video Training at Pre-Op, 1 Day Prior to surgery, 3 day's Post OP and 2 Weeks Post OP.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Meditation Training
Intervention Description
Patient will watch a 10 minute video on how to use mindfulness meditation to help with sleep after a total joint replacement procedure.
Primary Outcome Measure Information:
Title
Pittsburg Sleep Quality Index score
Description
Improvement in Pittsburg Sleep Quality Index (PSQI) score, Scale is 0 to 21, higher score is worse outcome.
Time Frame
Change from Pre-Op to 2, 6 and 12 weeks post op.
Secondary Outcome Measure Information:
Title
Visual Analog Score
Description
Improvement in Visual Analog Score (VAS), Scale is 1 to 10, higher score is worse outcome
Time Frame
Change from Pre-Op to 2, 6 and 12 weeks post op.
Title
Epworth Sleepiness Scale
Description
Improvement in Epworth Sleepiness Scale (ESS), Scale is 0 to 24, higher score is worse outcome
Time Frame
Change from Pre-Op to 2, 6 and 12 weeks post op.
Title
Knee Injury and Osteoarthritis Outcome Scores JR
Description
Improvement in Knee Injury and Osteoarthritis Outcome Scores JR (KOOS JR), Scale is 1 to 100, lower score is worse outcome
Time Frame
Change from Pre-Op to 2, 6 and 12 weeks post op.
Title
Knee Society Score (KSS)
Description
Improvement in Knee Society Score (KSS), Scale is 0 to 100, lower score is worse outcome
Time Frame
Change from Pre-Op to 6 Weeks post op.
Title
Patient Reported Outcome Measurement Information System - Sleep Disturbance (PROMIS-SD)
Description
Improvement in Patient Reported Outcome Measurement Information System - Sleep Disturbance (PROMIS-SD), Scale is 8 to 40, higher score is worse outcome
Time Frame
Change from Pre-Op to 2, 6 and 12 weeks post op.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roseann Johnson, BS, CCRP
Phone
7203552190
Email
roseannjohnson@centura.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason M Jennings, MD, DPT
Organizational Affiliation
Colorado Joint Replacement
Official's Role
Principal Investigator
Facility Information:
Facility Name
Colorado Joint Replacement
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roseann Johnson, BS, CCRP
Phone
303-260-2940
Email
RoseannJohnson@centura.org
First Name & Middle Initial & Last Name & Degree
Jason Jennings, MD
First Name & Middle Initial & Last Name & Degree
Douglas Dennis, MD
First Name & Middle Initial & Last Name & Degree
Todd Miner, MD
First Name & Middle Initial & Last Name & Degree
Jessica Phillips, MD
First Name & Middle Initial & Last Name & Degree
Hayley Ennis, MD
First Name & Middle Initial & Last Name & Degree
Charlie Yang, MD

12. IPD Sharing Statement

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

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