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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help women veterans manage chronic pelvic pain by comparing a special program called Acceptance and Commitment Training (ACT) to usual care. ACT includes weekly sessions where participants learn skills to better manage pain and lead fulfilling lives. Women veterans with chronic pelvic pain who experience moderate to severe discomfort may be suitable for this trial. Participants will either join the ACT group or receive usual care resources, and their experiences will help determine the best treatment outcomes for future studies. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance pain management strategies for women veterans.

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 prior data suggests that this protocol is safe for women veterans with pelvic pain?

Research has shown that Acceptance and Commitment Therapy (ACT) is generally safe and well-tolerated for managing chronic pain. One study found that using ACT in group settings for chronic pain did not cause any serious side effects, suggesting it is safe for most people. Another review found that ACT can help those with conditions like chronic pelvic pain, which are part of central pain sensitization syndromes. Existing evidence for ACT in similar situations shows minimal risk, making it a promising option for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Brief Acceptance and Commitment Training (ACT) with Chronic Pelvic Pain (CPP) education because it offers a new approach to managing pelvic pain. Unlike standard treatments that often focus on medication or physical therapies, this method emphasizes psychological flexibility. Participants learn to respond to pain in more adaptive ways and engage in meaningful activities, which can improve their quality of life. This approach could provide a complementary option to existing therapies, potentially benefiting those who haven't found relief through traditional methods.

What evidence suggests that this trial's treatments could be effective for pelvic pain?

Research shows that Acceptance and Commitment Training (ACT) can help people with chronic pelvic pain. Studies have found that ACT lessens symptoms like anxiety, depression, and pain by promoting acceptance of pain and boosting mental well-being. This method teaches patients to handle their pain differently and focus on activities that matter to them, which can help manage chronic conditions better. In this trial, participants in the Brief ACT with CPP Education Group will attend weekly sessions to learn these skills. Evidence suggests that combining education and skills training in ACT is promising for managing pelvic pain. While this specific trial is still collecting data, past evidence supports ACT's potential to improve the quality of life for those with chronic pelvic pain. ^{1 5 6 7 8}

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

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) 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]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06062043/pelvic-pain-education-and-skills-training-for-women-veterans?id=57&slug=dysmenorrhea-painful-periods

Pelvic Pain Education and Skills Training for Women ... a brief Acceptance and Commitment Training (ACT) group intervention for women veterans with pelvic pain compared to usual care; 2) assess ...

2. withpower.com withpower.com/trial/phase-pelvic-pain-9-2023-7f882

Pelvic Pain Education and Skills Training 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.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8235706/

Effectiveness of Acceptance and Commitment Therapy in ... ACT reduces some clinical symptoms, such as anxiety, depression, and pain. This positive effect of ACT might be mediated by pain acceptance, psychological ...

4. iasp-pain.org iasp-pain.org/publications/relief-news/article/act-pain-and-opioid-abuse/

Acceptance and Commitment Therapy for Prevention of ... Drs Dindo and Rakel and their team evaluated the preliminary effectiveness of a brief 1-day Acceptance and Commitment Training (ACT) workshop as a pre-surgical, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9543918/

Predictors of outcomes following interdisciplinary acceptance ... This aim of this study was to investigate if baseline psychological flexibility (PF) profiles predict responses to an ACT‐based pain management programme.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3824075/

A Trial of a Brief Group-Based Form of Acceptance and ... This article presents a pilot randomized controlled trial of ACT for chronic pain in a primary care setting in the United Kingdom.

7. mdpi.com mdpi.com/2077-0383/10/12/2706

Effectiveness of Acceptance and Commitment Therapy in ... The main objective of the present systematic review was to determine the effectiveness of ACT in patients with central pain sensitization syndromes (CPSS).

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05899088

NCT05899088 | Mindful Movement for Pelvic Pain Chronic pelvic pain is often associated with negative cognitive, behavioral, sexual and emotional consequences, which can include physical deconditioning, pain ...