The Perioperative Pain Self-Management Program Trial (PePS)

August 1, 2025 updated by: VA Office of Research and Development

Preventing Chronic Post-Surgical Pain and Prolonged Opioid Use: The Perioperative Pain Self-Management Program

This study will trial the impact of teaching surgical patients a pain self-management approach to compliment medical post-surgical pain management.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Surgery can precipitate the development of both chronic pain and long-term opioid use. There is a need for strategies to augment perioperative pharmacotherapeutic management of pain with non-pharmacologic strategies to prevent long-term sequelae. Psychological interventions such as cognitive behavioral therapy (CBT) can effectively reduce distress and improve functioning among patients with chronic pain. While CBT has been used extensively in patients with established chronic pain, it has not been used as a preventive intervention targeting the transition from acute to chronic postsurgical pain. The Perioperative Pain Self-management (PePS) program has the potential to reduce the incidence of chronic post-surgical pain and long-term opioid use among Veterans. This study will: Examine the efficacy of PePS compared to standard care on 6-month pain (primary outcome), mood and functioning outcomes as well as time to post-surgical opioid and other analgesic use cessation.

Study Type

Interventional

Enrollment (Actual)

401

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52246-2292
        • Iowa City VA Health Care System, Iowa City, IA
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417-2309
        • Minneapolis VA Health Care System, Minneapolis, MN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • inability to complete study forms/procedures because of a language/literacy barrier
  • active bipolar or psychotic disorder
  • history of brain injury
  • dementia
  • CBT therapy within the past year
  • lack of access to a telephone for PePS sessions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PePS
4 sessions of telephone CBT-based pain self-management in addition to standard perioperative care.
Behavioral: Perioperative Pain Self-management (PePS)
4 sessions of telephone CBT-based pain self-management.
Other Names:
  • PePS
No Intervention: Standard Care
Standard perioperative care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Pain Rating Scale
Time Frame: 6-months post-surgery

Surgical Site Pain

The Numeric Rating Scale (NRS) is a 0-10 measure where 0 = no pain.
6-months post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
opioid use
Time Frame: time to cessation post surgery (weekly phone calls for the first 6 weeks)
Time to opioid cessation following surgery: daily opioid use will be collected via weekly phone calls for the first 6 weeks post-surgery.
time to cessation post surgery (weekly phone calls for the first 6 weeks)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire 8-item version (PHQ-8)
Time Frame: Change between pre-surgery and 6-months post-surgery
A measure of depressive symptoms. Scores range from 0-24 with higher scores indicating more depressive symptoms.
Change between pre-surgery and 6-months post-surgery
General Anxiety Disorder Scale: 7-item (GAD-7)
Time Frame: Change between pre-surgery and 6-months post-surgery
A measure of anxious symptoms. Scores range from 0-21 with higher scores indicating more anxious symptoms.
Change between pre-surgery and 6-months post-surgery
Pain Disability Index (PDI)
Time Frame: Change between pre-surgery and 6-months post-surgery
A measure of pain-related functioning. Scores range from 0-70 with higher scores indicating greater pain-related disability.
Change between pre-surgery and 6-months post-surgery
Brief pain inventory
Time Frame: 6 months post-surgery
Generalized body pain intensity and pain interference. Scores range from 0-10 with higher scores indicating more pain severity and interference.
6 months post-surgery
Other analgesic use
Time Frame: time to cessation post-surgery (weekly phone calls for the first 6 weeks post-surgery)
Time to cessation of other analgesics following surgery: daily analgesic use will be collected via weekly phone calls for the first 6 weeks post-surgery.
time to cessation post-surgery (weekly phone calls for the first 6 weeks post-surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Katherine E Hadlandsmyth, PhD MA MS, Iowa City VA Health Care System, Iowa City, IA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2021

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

July 15, 2021

First Submitted That Met QC Criteria

July 26, 2021

First Posted (Actual)

July 28, 2021

Study Record Updates

Last Update Posted (Actual)

August 3, 2025

Last Update Submitted That Met QC Criteria

August 1, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIR 20-115

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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