Mindfulness Meditation Training for Sleep Disorder

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Sleep Disorder+1 MoreMindfulness Meditation Training - Behavioral
Eligibility
18 - 90
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study whether a 15 minute mindfulness meditation can improve sleep quality in those undergoing primary unilateral total joint arthroplasty.

Eligible Conditions
  • Sleep Disorder
  • Arthropathies

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Change from Pre-Op to 2, 6 and 12 weeks post op.

Week 12
Epworth Sleepiness Scale
Knee Injury and Osteoarthritis Outcome Scores JR
Patient Reported Outcome Measurement Information System - Sleep Disturbance (PROMIS-SD)
Pittsburg Sleep Quality Index score
Visual Analog Score
Week 6
Knee Society Score (KSS)

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

No Treatment
1 of 3
Multiple Mindfulness Meditation
1 of 3
Mindfulness at Pre-Op
1 of 3

Active Control

Experimental Treatment

282 Total Participants · 3 Treatment Groups

Primary Treatment: Mindfulness Meditation Training · No Placebo Group · N/A

Multiple Mindfulness Meditation
Behavioral
Experimental Group · 1 Intervention: Mindfulness Meditation Training · Intervention Types: Behavioral
Mindfulness at Pre-Op
Behavioral
Experimental Group · 1 Intervention: Mindfulness Meditation Training · Intervention Types: Behavioral
No TreatmentNoIntervention Group · 1 Intervention: No Treatment · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindfulness Meditation Training
2019
N/A
~250

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: change from pre-op to 2, 6 and 12 weeks post op.

Who is running the clinical trial?

Colorado Joint ReplacementLead Sponsor
11 Previous Clinical Trials
2,939 Total Patients Enrolled
Jason M Jennings, MD, DPTPrincipal InvestigatorColorado Joint Replacement

Eligibility Criteria

Age 18 - 90 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients undergoing primary unilateral total joint arthroplasty at Colorado Joint Replacement.

Who else is applying?

What state do they live in?
Washington100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Colorado Joint Replacement100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
References