The Perioperative Pain Self-Management Program Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

401 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-03

Study Completion Date

2026-09-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized to either receive the pain self-management sessions (PePS) or standard care (SC).

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

The outcomes assessor will be blinded to randomization status.

Study Groups

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PePS

4 sessions of telephone CBT-based pain self-management in addition to standard perioperative care.

Group Type EXPERIMENTAL

Perioperative Pain Self-management (PePS)

Intervention Type BEHAVIORAL

4 sessions of telephone CBT-based pain self-management.

Standard Care

Standard perioperative care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Perioperative Pain Self-management (PePS)

4 sessions of telephone CBT-based pain self-management.

Intervention Type BEHAVIORAL

Other Intervention Names

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PePS

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No