Pain Self-Management for Postoperative Pain

(PePS Trial)

Recruiting at 2 trial locations

Overseen By Katherine E Hadlandsmyth, PhD MA MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Bipolar, Psychotic disorder, Brain injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

401 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Do I need to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on teaching pain self-management alongside your existing medical pain management.

What safety data exists for the Pain Self-Management treatment?

The provided research abstracts do not directly address the safety data for the Pain Self-Management treatment or its variants like PePS. They focus on general postoperative pain management strategies, the impact of preoperative distress, and the importance of effective pain management. Specific safety data for the Pain Self-Management intervention would require further investigation into studies specifically evaluating this treatment. ^{1 2 3 4 5}

Is the Pain Self-Management for Postoperative Pain treatment safe for humans?

The available research does not provide specific safety data for the Pain Self-Management for Postoperative Pain treatment, but it suggests that effective pain management, when tailored to individual needs, can minimize medication side effects and improve patient outcomes. ^{1 2 3 4 5}

Is the treatment Perioperative Pain Self-management (PePS) a promising treatment for managing pain after surgery?

Yes, Perioperative Pain Self-management (PePS) is a promising treatment because it focuses on educating patients about managing their pain, which can lead to better pain control, faster recovery, and higher patient satisfaction. Effective pain management can also reduce hospital stays and costs. ^{3 5 6 7 8}

How is the Perioperative Pain Self-management (PePS) treatment different from other postoperative pain treatments?

The Perioperative Pain Self-management (PePS) treatment is unique because it focuses on educating patients to manage their own pain, rather than relying solely on medications like opioids. This approach empowers patients with strategies to control pain through self-management techniques, which can lead to better pain control and potentially reduce the need for medication. ^{3 5 6 7 8}

What data supports the idea that Pain Self-Management for Postoperative Pain is an effective treatment?

The available research shows that Pain Self-Management for Postoperative Pain can be effective, especially for patients who are distressed before surgery. One study highlights that patients who participated in this treatment reported positive experiences, suggesting it helps reduce the risk of long-term pain after surgery. This treatment involves psychological support, which can be beneficial compared to relying solely on medications like opioids, which are often not enough to manage pain effectively. Additionally, the treatment can improve patient comfort and satisfaction, potentially reducing the time spent in the hospital. ^{2 8 9 10 11}

What data supports the effectiveness of the treatment Perioperative Pain Self-management (PePS) for managing postoperative pain?

Research suggests that psychological interventions like PePS can help reduce chronic postsurgical pain, especially in patients who are distressed before surgery. This approach involves teaching patients pain self-management skills, which can complement standard medical care and potentially reduce reliance on pain medications. ^{2 8 9 10 11}

Who Is on the Research Team?

Katherine E Hadlandsmyth, PhD MA MS

Principal Investigator

Iowa City VA Health Care System, Iowa City, IA

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am scheduled for a hip, knee, or shoulder replacement surgery at specified VA centers.

Exclusion Criteria

Inability to complete study forms/procedures because of a language/literacy barrier

I have undergone CBT therapy in the last year.

I do not have an active bipolar or psychotic disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgery Intervention

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

4 weeks

4 sessions (telephone)

Post-surgery Monitoring

Participants' opioid and analgesic use is monitored via weekly phone calls for the first 6 weeks post-surgery

6 weeks

6 calls (weekly)

Follow-up

Participants are monitored for pain, mood, and functioning outcomes at 6 months post-surgery

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Perioperative Pain Self-management (PePS)

Trial Overview 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.

How Is the Trial Designed?

Group I: PePS Experimental Treatment 1 Intervention

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

Group II: Standard Care Active Control 1 Intervention

Standard perioperative care.

Perioperative Pain Self-management (PePS) is already approved in United States for the following indications:

Approved in United States as PePS for:

• Post-surgical pain management

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

The Perioperative Pain Self-management (PePS) intervention was beneficial for both preoperatively distressed and non-distressed patients, with distressed participants finding pain reframing techniques most helpful, while non-distressed participants preferred relaxation skills.

Both groups highlighted the importance of social support during the intervention, suggesting that personalized approaches may enhance pain management strategies for different patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Preoperative Distress: A Qualitative analysis of the Perioperative Pain Self-Management Intervention. Steffensmeier, KS., Van Tiem, J., Obrecht, A., et al.[2023]

Regular pain measurement and documentation by nurses, along with proper analgesic prescriptions, are crucial for effective postoperative pain management in small hospitals.

Implementing a nurse-based acute pain service with patient-controlled analgesia (PCA) systems can enhance patient comfort and satisfaction, potentially leading to shorter hospital stays in fast-track rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Organization model for postoperative pain management in a basic-care hospital]. Bernd, W., Seintsch, H., Amstad, R., et al.[2018]

Hospitals certified under the TÜV Rheinland quality management program showed significant improvements in postoperative pain management, with reductions in maximum pain scores and increased patient satisfaction after implementing the program.

Participation in the QUIPS benchmarking project also led to notable improvements in stress pain and patient satisfaction, indicating that both quality management approaches effectively enhance postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of the "initiative pain-free clinic" for quality improvement in postoperative pain management. A prospective controlled study]. Lehmkuhl, D., Meissner, W., Neugebauer, EA.[2021]

Patient education is crucial for effective postoperative pain management, yet many hospitals do not implement consistent and complete education practices, which can lead to inadequate pain control despite opioid use.

This review of 12 studies highlights the importance of tailored educational interventions, including optimal timing, delivery methods, and a multidisciplinary approach, to improve patient understanding and safety in opioid use after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Perioperative Pain Education for Patients Prescribed Opioids: An Integrative Review. Lee, YJ., Rosenberg, C.[2023]

A study involving 21 U.S. Military Veterans revealed that patients felt ambivalent about using opioids post-surgery, indicating a need for better education on pain management options.

Participants reported that learning pain self-management skills helped them reduce their reliance on opioids, leading to longer intervals between doses and increased confidence in managing their pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Military Veterans' Perspectives on Postoperative Opioid Use: A Secondary Analysis of Qualitative Data. Conrad, M., Steffensmeier, KS., Van Tiem, J., et al.[2023]

A quality assurance program for postoperative pain management (POPM) introduced over 3 years ago has led to significant improvements in pain management routines and patient satisfaction on surgical wards, as evidenced by survey data from 110 patients and 51 staff members.

The program, which utilized a nurse-based anesthesiologist-supervised model, resulted in better preoperative information and discussions about pain management, ultimately enhancing staff confidence and reducing reported pain and discomfort in patients post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative pain management on surgical wards--do quality assurance strategies result in long-term effects on staff member attitudes and clinical outcomes? Stomberg, MW., Wickström, K., Joelsson, H., et al.[2019]

Effective postoperative pain management is crucial and should be systematic, utilizing a variety of methods tailored to individual patient needs and circumstances, including physician expertise and available resources.

Opioids remain the cornerstone of pain management, and techniques like thoracic epidural analgesia (TEA) combined with local anesthetics can significantly benefit high-risk patients, emphasizing the importance of a balanced analgesic approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative pain management. Jain, S., Datta, S.[2005]

Effective pain management is crucial for children after surgery, as four out of five children experience significant pain postoperatively, which can have lasting negative effects on their health.

Recent advancements in pain management strategies have shown that children can undergo major surgeries with minimal adverse effects when proactive analgesia is provided, highlighting the importance of safe and easy-to-administer pain relief methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current management of pediatric postoperative pain. Kokki, H.[2005]

Effective management of postoperative pain is crucial as it can lead to benefits such as reduced hospital stays, lower costs, and increased patient satisfaction, but it must be personalized based on individual patient needs.

Despite the importance of pain management, it remains underutilized due to challenges like insufficient education, fear of complications from analgesics, and inadequate pain assessment methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical aspects of acute post-operative pain management & its assessment. Gupta, A., Kaur, K., Sharma, S., et al.[2022]

A survey of 80 Dutch hospitals revealed that 90% have an Acute Pain Service (APS), which plays crucial roles in patient rounds, pain education, and quality improvement in pain management.

Despite the presence of APSs, nearly half of the hospitals do not provide regular pain training, and 13% do not offer any patient information about pain management, indicating gaps in postoperative pain management practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute pain services and postsurgical pain management in the Netherlands: a survey. van Boekel, RL., Steegers, MA., Verbeek-van Noord, I., et al.[2022]

A study involving 100 subjects from four public hospitals in Mexico revealed that many children, including 30 newborns, received inadequate pain management after surgery, with common analgesics like paracetamol and dipyrone often administered at low doses.

The study highlighted significant gaps in pain documentation and management practices, indicating a need for improved training for healthcare professionals in evaluating and treating postoperative pain in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Errors in managing postsurgical pediatric pain in Mexico. Bravo Matus, CA., Flores Zúñiga, RM.[2011]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

The Impact of Preoperative Distress: A Qualitative analysis of the Perioperative Pain Self-Management Intervention. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

[Organization model for postoperative pain management in a basic-care hospital]. [2018]

3. Germany pubmed.ncbi.nlm.nih.gov

[Evaluation of the "initiative pain-free clinic" for quality improvement in postoperative pain management. A prospective controlled study]. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Improving Perioperative Pain Education for Patients Prescribed Opioids: An Integrative Review. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Military Veterans' Perspectives on Postoperative Opioid Use: A Secondary Analysis of Qualitative Data. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Postoperative pain management on surgical wards--do quality assurance strategies result in long-term effects on staff member attitudes and clinical outcomes? [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Postoperative pain management. [2005]

8. England pubmed.ncbi.nlm.nih.gov

Current management of pediatric postoperative pain. [2005]

9. India pubmed.ncbi.nlm.nih.gov

Clinical aspects of acute post-operative pain management & its assessment. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Acute pain services and postsurgical pain management in the Netherlands: a survey. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Errors in managing postsurgical pediatric pain in Mexico. [2011]