Pelvic Pain Education and Skills Training for Pelvic Pain

Overseen By Derrecka M Boykin, Ph.D.

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Disqualifiers: Cognitive impairment, Bipolar, Psychotic, others

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

Compensation: Varies

Number of Visits: 7

Duration: 6 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goals of this pilot randomized clinical trial are three-fold: 1) to test the feasibility of conducting a larger randomized trial using a brief Acceptance and Commitment Training (ACT) group intervention for women veterans with pelvic pain compared to usual care; 2) assess treatment acceptability by women veterans, and 3) identify appropriate pain-related treatment outcomes for the larger randomized trial. Participants will be randomly assigned to participate in either the ACT condition or treatment as usual condition, complete three surveys (before, after, and 3-months after first survey), and complete a phone interview (if assigned to the ACT condition). Researchers will compare the ACT condition and treatment as usual condition to see if there are meaningful differences in health outcomes. Due to the small sample size and pilot nature of this study, significance testing will not be performed.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you must be stable on mood and pain medication for four weeks before participating.

What safety data exists for Pelvic Pain Education and Skills Training for Pelvic Pain?

The provided research does not directly address the safety data for Pelvic Pain Education and Skills Training or its variants like Brief ACT with CPP Education Treatment. The studies focus on different aspects of pain education, such as chronic widespread pain, cancer pain, and perioperative pain management, but do not provide specific safety data for the treatment in question. ^{1 2 3 4 5}

Is the treatment Brief ACT with CPP Education promising for pelvic pain?

Yes, Brief ACT with CPP Education is promising because it combines education and skills training, which can help people better manage their chronic pelvic pain. This approach is valuable because it addresses the need for more effective education and care for those suffering from this condition. ^{6 7 8 9 10}

What data supports the idea that Pelvic Pain Education and Skills Training for Pelvic Pain is an effective treatment?

The available research does not provide specific data or evidence supporting the effectiveness of Pelvic Pain Education and Skills Training for Pelvic Pain. The articles focus on understanding chronic pelvic pain, its management, and the need for interdisciplinary care, but they do not offer direct evidence or comparisons to other treatments for this specific therapy. ^{7 11 12 13 14}

Are You a Good Fit for This Trial?

This trial is for US women veterans with chronic pelvic pain who have stable mood and pain medication use, and experience moderate to severe pain and distress. They must not be undergoing other treatments that could affect their pain, nor have cognitive impairments or uncontrolled bipolar/psychotic disorders.

Inclusion Criteria

Served in US Armed Forces

I identify as a female.

I have been diagnosed with chronic pelvic pain.

Exclusion Criteria

You are currently thinking about hurting yourself or someone else.

I have difficulty with memory or thinking clearly.

I am currently in psychotherapy or had Acceptance and Commitment Therapy within the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the ACT group attend weekly 90-minute sessions for up to six weeks to learn new ways to respond to their pain and engage in meaningful activities

6 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including completing surveys and interviews

3 months

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Brief ACT with CPP Education Treatment

Trial Overview The study tests a brief Acceptance and Commitment Training (ACT) group intervention against usual care for managing pelvic pain in women veterans. Participants will complete surveys and some will do phone interviews to assess the effectiveness of ACT.

How Is the Trial Designed?

Group I: Brief ACT with CPP Education Group Experimental Treatment 1 Intervention

The Brief Acceptance and Commitment Training (ACT) with Chronic Pelvic Pain (CPP) education Group will attend weekly 90-minute sessions for up to six weeks to learn new ways to respond to their pain and engage in meaningful activities.

Group II: Enhanced Treatment as Usual Active Control 1 Intervention

The enhanced treatment as usual (TAU) condition will receive a letter with CPP-specific treatment resources and encouraged to consult with their VHA primary care clinicians for additional education and treatment options.

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

US Department of Veterans Affairs

Collaborator

Trials

881

Recruited

502,000+

Published Research Related to This Trial

A survey of 136 women with chronic pelvic pain revealed that they are most interested in learning about diagnosis, treatment, coping strategies, and diet/exercise related to their condition, indicating a strong need for targeted educational resources.

After participating in a webinar designed to address these educational needs, patients reported a significant reduction in pain-related interference, suggesting that such educational programs can effectively empower patients to manage their symptoms better.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Responding flexibly to the complex problem of chronic pelvic pain: Incorporating patient needs into program development. Kreher, DA., Gubbels, AL., Eastin, S., et al.[2023]

Chronic pelvic pain (CPP) is a prevalent and debilitating condition in women, leading to significant personal suffering and healthcare costs, with treatments often showing variable success due to the complex and poorly understood nature of its underlying causes.

The study emphasizes the importance of a multidisciplinary approach to managing CPP, including assessments of myofascial dysfunction, rehabilitation strategies that focus on improving function rather than seeking a complete cure, and careful use of opioids, alongside recommendations for increased training and research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

No. 164-Consensus Guidelines for the Management of Chronic Pelvic Pain. Jarrell, JF., Vilos, GA., Allaire, C., et al.[2019]

Chronic pelvic pain (CPP) is often not recognized as a distinct diagnosis by general practitioners (GPs) and practice nurses, leading to challenges in management and a reliance on exclusionary diagnoses.

There is a significant need for education and training among GPs and practice nurses regarding CPP, as they expressed discomfort in managing this condition, highlighting the potential for developing targeted self-management strategies similar to those used for irritable bowel syndrome (IBS).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is chronic pelvic pain a comfortable diagnosis for primary care practitioners: a qualitative study. McGowan, L., Escott, D., Luker, K., et al.[2021]

Chronic pelvic pain (CPP) diagnosis and treatment have shifted to a multifactorial and multidisciplinary approach, recognizing that responses to treatment can vary significantly among patients.

Recent advancements include the development of new classification systems and a multimodal clinical phenotype system, which help in understanding the underlying causes of CPP and guiding personalized therapy across various medical specialties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current advancements in the diagnosis and treatment of chronic pelvic pain. Morrissey, D., Ginzburg, N., Whitmore, K.[2014]

Chronic pelvic pain (CPP) is a prevalent condition among women, often leading to significant functional impairment and mood disturbances, particularly in those referred to gynecologists.

A structured assessment using a cognitive behavioral model is recommended to better understand the impact of CPP on patients' daily lives and to improve referral processes for pain management, although further studies are needed to validate this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cognitive behavioural based assessment of women with chronic pelvic pain. Weijenborg, PT., Ter Kuile, MM., Stones, W.[2022]

The Pain School educational program, which includes four group sessions and 10 weeks of physical activity, effectively helps women with chronic widespread pain (CWP) develop skills and perspectives to better manage their pain, as reported by participants in a qualitative study of 12 women aged 25-72.

Participants experienced increased understanding of their bodies and minds, valued social interaction, and learned new strategies for coping with pain, indicating that the program provides practical tools for improving self-efficacy in managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences with an educational program for patients with chronic widespread pain: a qualitative interview study. Goksör, C., Mannerkorpi, K., Bergenheim, A.[2022]

The Cancer Pain Education for Patients and the Public (CPEPP) project aims to enhance pain management by providing essential education to patients and the public about cancer-related pain.

The CPEPP curriculum offers resources and support to ensure effective implementation of pain education, highlighting its importance in improving overall pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer pain education for patients and the public. Ferrell, BR., Juarez, G.[2019]

Biopsychosocial education strategies significantly improved pain-related knowledge by 18.8% and attitudes by 11.3% among healthcare professionals and students, based on a systematic review of 15 studies involving over 6,000 participants.

While the education showed a trend towards improving clinical behavior (with an odds ratio of 2.4), the impact on actual patient outcomes remains inconclusive, indicating a need for further research to confirm these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review and Meta-Analysis of the Effects of Biopsychosocial Pain Education upon Health Care Professional Pain Attitudes, Knowledge, Behavior and Patient Outcomes. Mankelow, J., Ryan, C., Taylor, P., et al.[2022]

A study of pediatric nursing courses in the U.K. revealed that many programs lack comprehensive content on pain management, particularly in areas like pain assessment and treatment methods.

Most nursing education still relies heavily on face-to-face teaching, with limited use of virtual learning tools, which may hinder the effective training of nurses in managing children's pain in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of pain content in three-year preregistration pediatric nursing courses in the United Kingdom. Twycross, A., Roderique, L.[2018]

A novel perioperative pain management simulation course significantly improved the confidence and knowledge of 17 junior anesthesia trainees in managing various aspects of pain, including chronic pain, intraoperative pain management, regional anesthesia, and labor analgesia.

Before the course, most trainees reported low confidence levels (below 6/10) in pain management, but after the simulation training, all trainees showed marked improvement, indicating the course's effectiveness in preparing them for real-life clinical scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative Pain Management Simulation Course: Improving Anesthesia Trainees' Confidence in the Management of Perioperative Pain and the Associated Critical Incidents. Afzaal, F., Zamora, PR., Sciberras, D., et al.[2023]

A scoping review identified that the educational milestones for obstetrics and gynecology (OBGYN) training do not align with current clinical guidelines for the evaluation and management of chronic pelvic pain (CPP), highlighting a gap in training.

The analysis revealed that while the AAGL Milestones included some competencies related to CPP, critical areas such as trauma-informed care and biopsychosocial assessments were missing, indicating opportunities for improvement in OBGYN education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IDENTIFYING GAPS IN PELVIC PAIN EDUCATION: A SCOPING REVIEW AND STRUCTURED ANALYSIS OF OBSTETRICS AND GYNECOLOGY TRAINING MILESTONES. Castellanos, ME., Carrillo, JF., Green, I., et al.[2023]

A 46-year-old woman with chronic pelvic pain and low back pain due to multiple pelvic fractures experienced an 80% reduction in pain after spinal cord stimulation using the Spectra WaveWriter system, which was more effective than pharmacologic treatments.

The use of 3D programming technology in spinal cord stimulation not only alleviated her pain but also significantly improved her quality of life, demonstrating a promising intervention for chronic pelvic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation in the approach to chronic pelvic pain: A case report and literature review. Romero-Serrano, E., Esparza-Miñana, JM.[2023]

In a survey of 498 patients at an outpatient gynecology clinic, 24% reported chronic pelvic pain (CPP), with 23% of those also having a second pain diagnosis, highlighting the common overlap of pain syndromes.

The study found that 15% of patients had symptoms of irritable bowel syndrome (IBS), 6% had interstitial cystitis (IC), and 5% had vulvodynia (VVD), indicating that clinicians should consider these conditions when evaluating patients with CPP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic pelvic pain syndrome-related diagnoses in an outpatient office setting. Fenton, BW., Brobeck, L., Witten, E., et al.[2015]

A survey of 57 obstetrics-gynecology residents revealed that 72% felt overwhelmed by patients with chronic pelvic pain (CPP) and believed they lacked adequate training to address these patients' needs.

Residents expressed a strong desire for more education on CPP, indicating a gap in their training that could impact the quality of care for women suffering from this common condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obstetrics-gynecology resident attitudes and perceptions about chronic pelvic pain: a targeted needs assessment to aid curriculum development. Witzeman, KA., Kopfman, JE.[2021]

Citations

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

Responding flexibly to the complex problem of chronic pelvic pain: Incorporating patient needs into program development. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

No. 164-Consensus Guidelines for the Management of Chronic Pelvic Pain. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Is chronic pelvic pain a comfortable diagnosis for primary care practitioners: a qualitative study. [2021]

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

Current advancements in the diagnosis and treatment of chronic pelvic pain. [2014]

5. England pubmed.ncbi.nlm.nih.gov

A cognitive behavioural based assessment of women with chronic pelvic pain. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Experiences with an educational program for patients with chronic widespread pain: a qualitative interview study. [2022]

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

Cancer pain education for patients and the public. [2019]

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

A Systematic Review and Meta-Analysis of the Effects of Biopsychosocial Pain Education upon Health Care Professional Pain Attitudes, Knowledge, Behavior and Patient Outcomes. [2022]

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

Review of pain content in three-year preregistration pediatric nursing courses in the United Kingdom. [2018]

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

Perioperative Pain Management Simulation Course: Improving Anesthesia Trainees' Confidence in the Management of Perioperative Pain and the Associated Critical Incidents. [2023]

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

IDENTIFYING GAPS IN PELVIC PAIN EDUCATION: A SCOPING REVIEW AND STRUCTURED ANALYSIS OF OBSTETRICS AND GYNECOLOGY TRAINING MILESTONES. [2023]

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

Spinal cord stimulation in the approach to chronic pelvic pain: A case report and literature review. [2023]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Chronic pelvic pain syndrome-related diagnoses in an outpatient office setting. [2015]

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

Obstetrics-gynecology resident attitudes and perceptions about chronic pelvic pain: a targeted needs assessment to aid curriculum development. [2021]