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Mindfulness-Based Intervention for Post-Knee Surgery Recovery (SEMPER Trial)

N/A

Recruiting

Research Sponsored by University of Utah

Eligibility Criteria Checklist

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

Must have

Scheduled to undergo unilateral total TKA at one of the study sites

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline,1 month, 3 months

Awards & highlights

SEMPER Trial Summary

This trial is testing whether a mindfulness-based intervention can help improve postoperative health and reduce chronic opioid use in patients who have undergone total knee arthroplasty.

Who is the study for?

This trial is for individuals with chronic knee pain who are TRICARE beneficiaries and scheduled for total knee arthroplasty. They must understand English well enough to follow study procedures but can't join if they have cognitive impairments, prior formal mindfulness training, severe suicidality, recent or planned contralateral TKA, or current cancer.Check my eligibility

What is being tested?

The study tests two mindfulness-based interventions: a single-session before surgery and an intensive 8-week program called MORE after surgery for those not helped by the first session. The goal is to improve post-surgery health and reduce opioid use by enhancing self-regulation.See study design

What are the potential side effects?

Mindfulness interventions like these typically do not cause physical side effects but may include temporary emotional discomfort as participants become more aware of their thoughts and feelings related to pain.

SEMPER Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am scheduled for a knee replacement surgery at a study site.

SEMPER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline,1 month, 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline,1 month, 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline,1 month, 3 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index

Secondary outcome measures

Defense and Veterans Pain Rating Scale

Distress

Health-related quality of life

+2 more

Other outcome measures

Cognitive reappraisal

Heart rate variability

Mindful reinterpretation of pain sensations

+6 more

SEMPER Trial Design

4Treatment groups

Experimental Treatment

Group I: Standard care followed by brief mindfulness for non-respondersExperimental Treatment2 Interventions

Patients will attend a 2-hour preoperative class involving pain coping education and are offered prehabilitation services. At the one-month post-surgical follow-up, non-responders will receive one session of brief mindfulness. Responders will continue to receive standard of care.

Group II: Standard care followed by MORE for non-respondersExperimental Treatment2 Interventions

Patients will attend a 2-hour preoperative class involving pain coping education and are offered prehabilitation services. At the one-month post-surgical follow-up, non-responders will receive the 8 session MORE intervention. Responders will continue to receive standard of care.

Group III: Brief mindfulness followed by brief mindfulness for non-respondersExperimental Treatment1 Intervention

1 session of brief mindfulness, plus standard of care. At the one-month post-surgical follow-up, non-responders will receive another single session of brief mindfulness. Responders will continue to receive standard of care.

Group IV: Brief mindfulness followed by MORE for non-respondersExperimental Treatment2 Interventions

1 session of brief mindfulness, plus standard of care. At the one-month post-surgical follow-up, non-responders will receive the 8 session MORE intervention. Responders will continue to receive standard of care.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mindfulness-Oriented Recovery Enhancement (MORE)

2017

N/A

~230

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Geneva FoundationOTHER

30 Previous Clinical Trials

11,894 Total Patients Enrolled

University of UtahLead Sponsor

1,099 Previous Clinical Trials

1,778,222 Total Patients Enrolled

Geneva FoundationUNKNOWN

3 Previous Clinical Trials

8,508 Total Patients Enrolled

Media Library

Brief mindfulness Clinical Trial Eligibility Overview. Trial Name: NCT05050409 — N/A

Chronic Knee Pain Research Study Groups: Brief mindfulness followed by MORE for non-responders, Standard care followed by brief mindfulness for non-responders, Brief mindfulness followed by brief mindfulness for non-responders, Standard care followed by MORE for non-responders

Chronic Knee Pain Clinical Trial 2023: Brief mindfulness Highlights & Side Effects. Trial Name: NCT05050409 — N/A

Brief mindfulness 2023 Treatment Timeline for Medical Study. Trial Name: NCT05050409 — N/A

Frequently Asked Questions

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

Is the process of enrollment open for this investigation?

"According to clinicaltrials.gov, this research project is actively enrolling participants and has been doing so since May 1st 2022. The trial information was last revised on July 12th of the same year."

Answered by AI

How many participants are eligible to partake in this trial?

"Affirmative. Clinicaltrials.gov corroborates that this medical experiment, inaugurated on May 1st 2022, is currently in search of participants. The study needs to collect data from 500 patients at a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

SMART Embedded Intervention for Military Postsurgical Engagement Readiness

Eric Garland 2022. "SMART Embedded Intervention for Military Postsurgical Engagement Readiness". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05050409.