Recruiting

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

Sponsor:

Colorado Joint Replacement

Code:

NCT05295004

Conditions

Sleep Disturbance

Arthropathy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Mindfulness Meditation Training

Study Details

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.

Conditions

Sleep Disturbance

Arthropathy

Study ID

NCT05295004

Start date

Mar 15, 2022

Status verified date

Jul, 2023

Completion date

Jul 31, 2024

Anticipated

Primary completion date

Mar 15, 2024

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

282 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

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.

Primary outcome measure

Pittsburg Sleep Quality Index score [ Time Frame: Change from Pre-Op to 2, 6 and 12 weeks post op. ]

Central Contacts and Locations

Central contacts

Roseann Johnson, BS, CCRP

7203552190 roseannjohnson@centura.org

Locations

Colorado Joint Replacement

Recruiting

Denver, Colorado, United States, 80210

Contacts

Roseann Johnson, BS, CCRP

303-260-2940 RoseannJohnson@centura.org

Principal Investigator:

Jason Jennings, MD

More Information

Sponsor

Colorado Joint Replacement

Last update posted

Jul 10, 2023

Last verified

Jul, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Colorado Joint Replacement on 2023-07-10.