Your session is about to expire
← Back to Search
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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months post-surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post-surgery
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 moreAwards & 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
1,664 Previous Clinical Trials
3,765,383 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have undergone CBT therapy in the last year.I do not have an active bipolar or psychotic disorder.You have had a previous brain injury.I am scheduled for a hip, knee, or shoulder replacement surgery at specified VA centers.Having memory and thinking problems.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Care
- Group 2: PePS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Share this study with friends
Copy Link
Messenger