Clinical Trial Finder

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 90 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05295004
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Colorado Joint Replacement
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Jason M Jennings, MD, DPT
Principal Investigator Affiliation Colorado Joint Replacement
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Sleep Disturbance, Arthropathy
Additional Details

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.

Arms & Interventions

Arms

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.

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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Colorado Joint Replacement, Denver, Colorado

Status

Recruiting

Address

Colorado Joint Replacement

Denver, Colorado, 80210

Site Contact

Roseann Johnson, BS, CCRP

[email protected]

303-260-2940

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