Mindfulness for Endometriosis

Overseen By Christa Coleman

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Milton S. Hershey Medical Center

Disqualifiers: Prior mindfulness training, unable to consent

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the use of mindfulness exercises to help women with endometriosis manage pelvic pain, especially after surgery. Participants will receive either mindfulness training or educational support alongside their regular surgical care. The researchers aim to determine if mindfulness can reduce stress and improve recovery post-surgery. Women diagnosed with, or suspected to have, endometriosis and scheduled for surgery might be suitable for this trial. Participants must have internet access and no prior formal mindfulness training. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance post-surgical recovery for women with endometriosis.

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

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

What prior data suggests that this mindfulness intervention is safe for endometriosis-related chronic pelvic pain?

Research has shown that mindfulness-based activities are generally safe and manageable for most people. These activities can improve the quality of life for individuals with endometriosis and reduce symptoms such as tiredness and pain. Studies have not reported any major negative effects from these practices. Mindfulness enhances focus and stress management, positively affecting the nervous system without causing physical side effects. This makes it a low-risk option for managing endometriosis-related pelvic pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using mindfulness as a treatment for endometriosis because it offers a non-invasive approach to managing pain and stress associated with the condition. Unlike traditional treatments, such as hormonal therapies and pain medications, which can have significant side effects, mindfulness focuses on reducing pain perception and enhancing the patient's overall well-being through mental training. This approach aims to empower patients by helping them develop skills to manage their symptoms more effectively, potentially reducing reliance on medications and improving quality of life.

What evidence suggests that this mindfulness intervention might be an effective treatment for endometriosis-related chronic pelvic pain?

Research has shown that mindfulness practices can help manage pain and stress. One study found that short mindfulness sessions improved focus and stress management in women. Another study discovered that these practices helped reduce endometriosis pain by changing how pain is felt and processed. In this trial, participants will receive either standard care for endometriosis surgery plus mindfulness or standard care plus education. Mindfulness training can improve quality of life by boosting mental well-being and coping skills. These findings suggest that mindfulness might be a useful tool for women with endometriosis-related pelvic pain. ^{1 2 4 6 7}

Who Is on the Research Team?

Christa Coleman

Principal Investigator

Penn State Health

Are You a Good Fit for This Trial?

This trial is for adult women (18+) with a diagnosis or probable diagnosis of endometriosis who are about to undergo surgery for the condition. Participants must speak English and have access to wifi and email.

Inclusion Criteria

I have been diagnosed or likely have endometriosis.

English speaking

Have access to wifi and email

Exclusion Criteria

I have completed a mindfulness training program.

I am unable to give consent by myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Intervention

Participants receive a single-session brief mindfulness-based intervention (BMBI) or education adjunctive to treatment as usual prior to their ECPP surgery

1 session

Surgical Treatment

Participants undergo surgical treatment for endometriosis-related chronic pelvic pain

1 day

Post-operative Follow-up

Participants are monitored for safety and effectiveness after surgery, including assessments of pain intensity, opioid use, and emotional functioning

3 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness Intervention

Trial Overview The study tests a single-session mindfulness-based intervention before surgery, compared to usual care plus pain education. It aims to see if this approach is feasible, acceptable, and potentially helpful in improving post-surgical outcomes like stress coping and pain management.

How Is the Trial Designed?

Group I: Standard of care for endometriosis surgery plus mindfulness Experimental Treatment 1 Intervention

Group II: Standard of care for endometriosis surgery plus education Active Control 1 Intervention

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

Published Research Related to This Trial

A brief Mindfulness-Based Intervention (bMBI) significantly reduced endometriosis-related pain, including pain unpleasantness and pelvic pain, in women who continued to experience symptoms despite standard medical treatment, with notable effect sizes indicating its efficacy.

bMBI also positively impacted mental health and quality of life, suggesting that it can be an effective complementary approach for managing both physical and psychological symptoms in women with endometriosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A single-blind, randomized, pilot study of a brief mindfulness-based intervention for the endometriosis-related pain management. Moreira, MF., Gamboa, OL., Pinho Oliveira, MA.[2022]

Pain is the primary stressor for women with endometriosis, and they often employ a mix of adaptive and maladaptive coping strategies, which can affect their mental health.

Women with endometriosis tend to suppress emotions and exhibit passive coping styles, which are linked to higher self-reported pain and poorer mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral, cognitive, and emotional coping strategies of women with endometriosis: a critical narrative review. Zarbo, C., Brugnera, A., Frigerio, L., et al.[2018]

In a study involving 144 patients with bipolar disorder undergoing Mindfulness-Based Cognitive Therapy (MBCT), adverse effects (AEs) were reported by 29 patients, with most occurring within the first three weeks and decreasing thereafter.

Despite the occurrence of AEs, most patients viewed them as part of a therapeutic process rather than harmful, indicating that while AEs are present, they are generally not serious and can be perceived positively in the context of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse or therapeutic? A mixed-methods study investigating adverse effects of Mindfulness-Based Cognitive Therapy in bipolar disorder. Hanssen, I., Scheepbouwer, V., Huijbers, M., et al.[2021]

A pilot program of Mindfulness-Based Cognitive Therapy (MBCT) for nine women with fertility issues showed clinically significant improvements in their wellbeing and reductions in psychological distress after treatment.

While the study could not account for the effects of concurrent treatments, the findings suggest that MBCT may be an effective approach for addressing distress related to fertility problems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a group programme of mindfulness-based cognitive therapy for women with fertility problems. Sherratt, KA., Lunn, S.[2013]

A brief mindfulness-based intervention (bMBI) significantly improved positive affect and reduced negative affect and pain catastrophizing in women with endometriosis, suggesting it can effectively help manage pelvic pain intensity and unpleasantness.

The improvements in quality of life related to mental health were achieved through multiple pathways, including direct effects on positive and negative emotions, indicating that enhancing emotional well-being can be beneficial for women suffering from endometriosis, beyond just pain reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-affective changes mediate the mindfulness-based intervention effect on endometriosis-related pain and mental health: A path analysis approach. Moreira, MF., Gamboa, OL., Pinho Oliveira, MA.[2023]

Mindfulness-based interventions (MBIs) significantly reduced stress levels in menopausal women, as shown by a meta-analysis of 1,138 participants across 13 studies, with a standardized mean difference of -0.84.

However, MBIs did not show significant effects on reducing anxiety or depression, nor did they significantly improve mindfulness scores, indicating that while MBIs can help with stress, their overall impact on other mental health aspects in menopausal women requires further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of mindfulness-based interventions on anxiety, depression, stress, and mindfulness in menopausal women: A systematic review and meta-analysis. Liu, H., Cai, K., Wang, J., et al.[2023]

A brief mindfulness-based intervention (bMBI) significantly reduces both sensory and affective pain dimensions in women with endometriosis, suggesting it can effectively alleviate pain associated with the condition.

The reduction in pain from bMBI also leads to decreased psychological stress and improved quality of life, indicating that incorporating mindfulness practices into treatment plans may enhance overall well-being for women suffering from endometriosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness intervention effect on endometriosis-related pain dimensions and its mediator role on stress and vitality: a path analysis approach. Moreira, MF., Gamboa, OL., Oliveira, MAP.[2023]

Mindfulness-based interventions (MBIs) significantly reduce short-term anxiety in cancer patients, with a standardized mean difference of -0.51 based on 23 trials involving 2339 participants.

MBIs also lead to reductions in short-term and medium-term depression and improve health-related quality of life, but no significant long-term anxiety reduction was observed after 6 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Mindfulness-Based Interventions With Anxiety Severity in Adults With Cancer: A Systematic Review and Meta-analysis. Oberoi, S., Yang, J., Woodgate, RL., et al.[2020]

A review of 12 publications involving various psychological and mind-body interventions suggests that these approaches may help alleviate pain, anxiety, depression, stress, and fatigue in women with endometriosis, although definitive conclusions cannot be drawn due to the lack of gold-standard methodologies.

The interventions studied included yoga, mindfulness, and cognitive behavioral therapy, indicating a range of potential non-pharmacological options for managing endometriosis symptoms, but future well-designed randomized controlled trials are needed to confirm their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological and mind-body interventions for endometriosis: A systematic review. Evans, S., Fernandez, S., Olive, L., et al.[2020]

An abbreviated Mindfulness-Based Stress Reduction (MBSR) program consisting of 6 weekly 75-minute sessions can effectively be implemented during staff lunch breaks, making it a practical training option for healthcare providers and clinic staff.

This adapted MBSR program is not only feasible but also well-accepted, suggesting it could enhance the well-being of healthcare workers in a workplace setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Stress Reduction for Health Care Staff: Expanding Holistic Nursing Paradigms to the Whole System. Hazlett-Stevens, H.[2021]

A systematic review of 18 studies found that Mindfulness Based Stress Reduction (MBSR) therapy significantly improves the conditions of patients with chronic illnesses such as cancer, hypertension, and diabetes.

MBSR offers a promising alternative treatment method that helps patients manage their diseases more effectively, although more research is needed to fully understand its mechanisms and potential adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction: a non-pharmacological approach for chronic illnesses. Niazi, AK., Niazi, SK.[2022]

Mindfulness-based stress reduction (MBSR) and mindfulness-based cognitive therapy (MBCT) significantly improved health-related quality of life, fatigue, sleep, stress, anxiety, and depression in women with breast cancer, based on a meta-analysis of 10 studies involving 1709 participants.

While these interventions showed short-term effectiveness, the average effects were below the threshold for minimal clinically important differences, indicating that while beneficial, their clinical relevance may need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based interventions for women with breast cancer: an updated systematic review and meta-analysis. Haller, H., Winkler, MM., Klose, P., et al.[2022]

Mindfulness-based therapy (MBT) significantly reduces symptoms of anxiety and depression in adult cancer patients and survivors, with moderate effect sizes observed in both nonrandomized studies (0.60 for anxiety, 0.42 for depression) and randomized controlled trials (0.37 for anxiety, 0.44 for depression).

The systematic review included 22 studies with a total of 1,403 participants, indicating that while the quality of studies varied, there is promising evidence from higher-quality randomized controlled trials supporting the efficacy of MBT in improving mental health outcomes for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of mindfulness-based therapy on symptoms of anxiety and depression in adult cancer patients and survivors: a systematic review and meta-analysis. Piet, J., Würtzen, H., Zachariae, R.[2022]

Mindfulness-based interventions (MBIs) have been shown to effectively improve a wide range of biopsychosocial conditions, such as depression, anxiety, and stress, and are considered relatively safe for use in various settings like healthcare, schools, and workplaces.

Despite their effectiveness, there is a need for more high-quality research to confirm the benefits of MBIs for certain conditions, such as PTSD and ADHD, and to explore their cost-effectiveness across different populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based interventions: an overall review. Zhang, D., Lee, EKP., Mak, ECW., et al.[2021]

Citations

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Mindfulness-Based Intervention Effect on the ... Results showed that bMBI (n = 26) significantly improved Flanker accuracy and Flanker and Stroop reaction time compared to the control group (n = 28). bMBI ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37524218/

Mindfulness-Based Intervention Effect on the ... This article demonstrates the positive impact of a brief Mindfulness-Based Intervention on attention and parasympathetic regulation in women suffering from ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1002/ejp.2149

Cognitive‐affective changes mediate the mindfulness ... Brief mindfulness-based intervention improves endometriosis pain through pain-related cognitive-affective factors and quality of life mental health.

4. jpain.org jpain.org/article/S1526-5900(23)00491-1/pdf

Mindfulness-Based Intervention Effect on the ... Results showed that bMBI (n = 26) significantly improved Flanker accuracy and Flanker and Stroop reaction time compared to the control group (n ...

5. jogc.com jogc.com/article/S1701-2163(24)00269-X/fulltext

Virtual Mindfulness-Based Therapy for the Management of ... This study assessed the effectiveness of a virtual mindfulness-based stress reduction (MBSR) program to improve quality of life and pain in people with ...

6. withpower.com withpower.com/trial/phase-endometriosis-2024-5925c

Mindfulness for Endometriosis Mindfulness-based stress reduction (MBSR) and mindfulness-based cognitive therapy (MBCT) significantly improved health-related quality of life, fatigue, sleep, ...

7. researchgate.net researchgate.net/publication/359178252_A_Single-blind_randomized_pilot_study_of_a_brief_Mindfulness-Based_Intervention_for_the_endometriosis-related_pain_management

A Single‐blind, randomized, pilot study of a brief ... Studies have suggested that mindfulness-based interventions can improve symptom severity directly, significantly reducing all endometriosis-associated and ...