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Behavioral Intervention

Pain Self-Management for Postoperative Pain (PePS Trial)

N/A
Recruiting
Led By Katherine E Hadlandsmyth, PhD MA MS
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Scheduled for total hip, knee, or shoulder joint arthroplasty through the Iowa City, IA, Des Moines, IA, Minneapolis, IA, or Milwaukee WI, VA medical centers
Be older than 18 years old
Must not have
Active bipolar or psychotic disorder
CBT therapy within the past year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-months post-surgery
Awards & highlights
No Placebo-Only Group

Summary

This trial will test how well a pain self-management approach works for people who just had surgery, in addition to their medical pain management.

Who is the study for?
This trial is for patients scheduled for hip, knee, or shoulder joint replacement at select VA medical centers in Iowa City, Des Moines, Minneapolis, or Milwaukee. Participants must be able to complete forms and have phone access. Those with severe mental health conditions, recent brain injury, dementia or recent CBT therapy cannot join.
What is being tested?
The study tests a Perioperative Pain Self-management (PePS) program designed to teach surgical patients how to manage their pain alongside standard medical care after surgery.
What are the potential side effects?
Since the intervention involves education and self-management techniques without medications or invasive procedures, no direct side effects are expected from PePS itself.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for a hip, knee, or shoulder replacement surgery at specified VA centers.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have an active bipolar or psychotic disorder.
Select...
I have undergone CBT therapy in the last year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post-surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post-surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Numeric Pain Rating Scale
Secondary study objectives
opioid use
Other study objectives
Brief pain inventory
General Anxiety Disorder Scale: 7-item (GAD-7)
Other analgesic use
+2 more

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: PePSExperimental Treatment1 Intervention
4 sessions of telephone CBT-based pain self-management in addition to standard perioperative care.
Group II: Standard CareActive Control1 Intervention
Standard perioperative care.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,666 Previous Clinical Trials
3,765,409 Total Patients Enrolled
Katherine E Hadlandsmyth, PhD MA MSPrincipal InvestigatorIowa City VA Health Care System, Iowa City, IA
Hilary J Mosher, MD MFA BAPrincipal InvestigatorIowa City VA Health Care System, Iowa City, IA

Media Library

Perioperative Pain Self-management (PePS) (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04979429 — N/A
Postoperative Pain Research Study Groups: Standard Care, PePS
Postoperative Pain Clinical Trial 2023: Perioperative Pain Self-management (PePS) Highlights & Side Effects. Trial Name: NCT04979429 — N/A
Perioperative Pain Self-management (PePS) (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04979429 — N/A
~60 spots leftby Jul 2025
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