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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PePS | Experimental | 4 sessions of telephone CBT-based pain self-management in addition to standard perioperative care. |
|
| Standard Care | No Intervention | Standard perioperative care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perioperative Pain Self-management (PePS) | Behavioral | 4 sessions of telephone CBT-based pain self-management. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Pain Rating Scale | Surgical Site Pain The Numeric Rating Scale (NRS) is a 0-10 measure where 0 = no pain. | 6-months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| opioid use | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire 8-item version (PHQ-8) | 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diana J. Burgess, PhD | Minneapolis VA Health Care System, Minneapolis, MN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Iowa City VA Health Care System, Iowa City, IA | Iowa City | Iowa | 52246-2292 | United States | ||
| Minneapolis VA Health Care System, Minneapolis, MN |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35660486 | Result | Hadlandsmyth K, Burgess DJ, Leparski RF, Odom AS, Campbell EJ, Obrecht AA, Adamowicz JL, Cho H, Steffensmeier KS, Johnson NL, Richards CC, Vander Weg MW, Lund BC, Yoon P, Mosher HJ. The Perioperative Pain Self-Management (PePS) randomized controlled trial protocol: Preventing chronic post-surgical pain and prolonged opioid use. Contemp Clin Trials. 2022 Jul;118:106810. doi: 10.1016/j.cct.2022.106810. Epub 2022 May 31. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Dec 21, 2023 | Jul 8, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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Participants will be randomized to either receive the pain self-management sessions (PePS) or standard care (SC).
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The outcomes assessor will be blinded to randomization status.
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) | 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 | 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 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) |
| Minneapolis |
| Minnesota |
| 55417-2309 |
| United States |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |