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The Perioperative Pain Self-Management Program Trial (PePS)

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VA Office of Research and Development

Status

Active, not recruiting

Conditions

Postoperative Pain

Treatments

Behavioral: Perioperative Pain Self-management (PePS)

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT04979429
IIR 20-115

Details and patient eligibility

About

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

Full 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.

Enrollment

401 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

401 participants in 2 patient groups

PePS
Experimental group
Description:
4 sessions of telephone CBT-based pain self-management in addition to standard perioperative care.
Treatment:
Behavioral: Perioperative Pain Self-management (PePS)
Standard Care
No Intervention group
Description:
Standard perioperative care.

Trial documents
1

Trial contacts and locations

2

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Central trial contact

Katherine E Hadlandsmyth, PhD MA MS

Data sourced from clinicaltrials.gov

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