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Mindfulness Meditation for Sleep Disorders

N/A

Recruiting

Led By Jason M Jennings, MD, DPT

Research Sponsored by Colorado Joint Replacement

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from pre-op to 2, 6 and 12 weeks post op.

Awards & highlights

Study Summary

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

Who is the study for?

This trial is for individuals aged 18-90 who are scheduled for a primary unilateral total joint arthroplasty at Colorado Joint Replacement. It's not open to those having simultaneous joint replacements, unable to attend pre-op appointments within 4 weeks of surgery, with a history of substance abuse, or needing revision surgeries.Check my eligibility

What is being tested?

The study tests if a 15-minute Mindfulness Meditation (MM) session before surgery can improve sleep quality post-surgery. Sleep quality is measured using the Pittsburg Sleep Quality Index (PSQI) at different intervals after the operation.See study design

What are the potential side effects?

Mindfulness Meditation is generally considered safe and side effects are rare. However, some individuals may experience temporary discomfort like restlessness or emotional distress during meditation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am having a joint replacement surgery at Colorado Joint Replacement.

Select...

I am between 18 and 90 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from pre-op to 2, 6 and 12 weeks post op.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from pre-op to 2, 6 and 12 weeks post op.

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from pre-op to 2, 6 and 12 weeks post op. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pittsburg Sleep Quality Index score

Secondary outcome measures

Epworth Sleepiness Scale

Knee Injury and Osteoarthritis Outcome Scores JR

Knee Society Score (KSS)

+2 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Multiple Mindfulness MeditationExperimental Treatment1 Intervention

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

Group II: Mindfulness at Pre-OpExperimental Treatment1 Intervention

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

Group III: No TreatmentActive Control1 Intervention

Patient will receive no mindfulness meditation training.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mindfulness Meditation Training

2019

N/A

~250

0 / 2Eligibility criteria met

Find a Location

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

Media Library

Mindfulness Meditation Training Clinical Trial Eligibility Overview. Trial Name: NCT05295004 — N/A

Sleep Disorder Research Study Groups: No Treatment, Mindfulness at Pre-Op, Multiple Mindfulness Meditation

Sleep Disorder Clinical Trial 2023: Mindfulness Meditation Training Highlights & Side Effects. Trial Name: NCT05295004 — N/A

Mindfulness Meditation Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT05295004 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical experiment have any openings for participants?

"Affirmative. Clinicaltrials.gov's records exhibit that the trial, which launched on March 15th 2022, is still in search of participants. Specifically, 282 patients are needed to be enrolled at a single location."

Answered by AI

Am I eligible to be a participant in this research project?

"This clinical trial is searching for 282 individuals with sleep difficulties aged 18 to 90. Eligible applicants must meet the following requirements: they must currently be undergoing primary unilateral total joint arthroplasty at Colorado Joint Replacement and fall within the age range of 18 through 90 years old."

Answered by AI

What is the enrollment capacity for this research project?

"Affirmative. Information on clinicaltrials.gov indicates that recruitment for this research trial is ongoing, having begun on March 15th 2022 and updated most recently 25 days later. A total of 282 people are needed to participate at one site."

Answered by AI