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Mindfulness App for Hip Surgery Recovery

N/A

Waitlist Available

Led By Andrew Watson, MD, MS

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

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

Must have

18-45 years old at the time of the pre-operative visit

Be between 18 and 65 years old

Must not have

Significant prior experience with meditation or mindfulness, defined as greater than 30 minutes in a month during the past year

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months, 6 months, 12 months, 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the effects of a mindfulness intervention on patients' outcomes following hip preservation surgery. The intervention will be delivered remotely, and patients will be monitored for changes in their anxiety, depression, pain, and function.

Who is the study for?

This trial is for individuals aged 18-45 who are undergoing hip preservation surgery and have access to a mobile device. They should not have significant prior experience with meditation or mindfulness, nor a history of serious mental illness like schizophrenia or bipolar disorder.

What is being tested?

The study tests the impact of an 8-week mindfulness program delivered through the Healthy Minds Program App on patient outcomes after hip surgery. It's a single-blind trial where patients don't know if they're using the actual app or a control version.

What are the potential side effects?

Since this intervention involves mindfulness exercises via an app, there aren't typical medical side effects; however, participants may experience emotional discomfort as they engage with their thoughts and feelings during practice.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 18 and 45 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have practiced meditation or mindfulness for more than 30 minutes a month in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months, 6 months, 12 months, 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months, 6 months, 12 months, 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months, 12 months, 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Hip Outcome Score (HOS-ADL and HOS-SS)

Change in International Hip Outcome Tool (IHOT) Score

Change in Modified Harris Hip Score (mHHS)

+3 more

Secondary study objectives

Total Duration of Mindfulness Training in the Mindfulness Group

Other study objectives

Summary of Pain Locations

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Mindfulness Intervention plus Standard of CareExperimental Treatment1 Intervention

The Foundations and Awareness modules of the HMP app require a minimum of 133 and 253 minutes, equating to less than 5 and less than 10 minutes per day on average, respectively. Date, duration, and content of usage will be recorded for each participant through the app. Participants will have access to the entire contents of the app for the full duration of the study.

Group II: Standard of CareActive Control1 Intervention

Control group receives standard of care only

0 / 2Eligibility criteria met