Trial Summary
What is the purpose of this trial?Endometriosis is a common cause of pelvic pain in women which has been historically under-studied and under-diagnosed. The goal of this research is to pilot-test the feasibility and acceptability of a manualized, single-session brief mindfulness-based intervention (BMBI) among participants with endometriosis-related chronic pelvic pain (ECPP) who undergo surgical treatment, and gather preliminary data necessary for future studies assessing BMBI's impact on outcomes in surgically-treated ECPP. This pilot study will enroll 10-20 adult participants with ECPP to receive either a BMBI adjunctive to treatment as usual (TAU; n=5-10) or education with TAU (n=5-10) prior to their ECPP surgery. The central hypothesis is the BMBI is feasible to deliver pre-operatively, acceptable to patients, and may help improve acute post-surgical outcomes through more adaptive stress coping and pain processing, enabled by mindfulness training.
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 data supports the idea that Mindfulness for Endometriosis is an effective treatment?
The available research shows that mindfulness-based interventions (MBIs) have been effective in improving mental health conditions like anxiety, depression, and stress in various groups, such as menopausal women and women with fertility problems. For instance, a study on women with fertility issues found significant improvements in their wellbeing and reduction in psychological distress after participating in a mindfulness-based cognitive therapy program. Although this research does not directly address endometriosis, it suggests that mindfulness can help manage stress and emotional challenges, which are often associated with endometriosis. This implies that mindfulness could be a beneficial treatment for endometriosis by helping to improve overall mental wellbeing.
12345What safety data exists for mindfulness treatments?
The provided research does not directly address safety data for mindfulness treatments like Mindfulness-Based Stress Reduction (MBSR) or Mindfulness-Based Cognitive Training. However, it suggests that these interventions are widely used across various conditions, including bipolar disorder, menopausal symptoms, cancer-related anxiety, and chronic illnesses. The studies imply that mindfulness interventions are generally considered feasible and acceptable, but specific adverse effects are not detailed in the abstracts.
16789Is mindfulness a promising treatment for endometriosis?
Yes, mindfulness is a promising treatment for endometriosis. It can help reduce pain and improve mental health by changing how women with endometriosis think and feel about their pain. Mindfulness can also lower stress and boost quality of life, making it a valuable addition to standard treatments.
1011121314Eligibility Criteria
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 am 18 years old or older.
I have been diagnosed or likely have endometriosis.
English speaking
+2 more
Exclusion Criteria
I have completed a mindfulness training program.
I am unable to give consent by myself.
Trial Timeline
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)
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Standard of care for endometriosis surgery plus mindfulnessExperimental Treatment1 Intervention
Group II: Standard of care for endometriosis surgery plus educationActive Control1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Penn State HealthHershey, PA
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Who Is Running the Clinical Trial?
Milton S. Hershey Medical CenterLead Sponsor
References
The effects of mindfulness-based interventions on anxiety, depression, stress, and mindfulness in menopausal women: A systematic review and meta-analysis. [2023]Mindfulness-based interventions (MBIs) are psychological interventions widely used in menopausal women. Currently, there is no evidence summary on the effectiveness of MBIs on anxiety, depression, stress, and mindfulness in menopausal women. This meta-analysis examines the effectiveness of MBIs in improving anxiety, depression, stress, and mindfulness scores in menopausal women.
Evaluation of a group programme of mindfulness-based cognitive therapy for women with fertility problems. [2013]Mindfulness-based cognitive therapy (MBCT) has proved helpful for a number of health-related conditions but there is relatively little published literature about its use with fertility problems. The aim of this paper is to describe a pilot group programme adopted by a Clinical Health Psychology department, and to present findings from the routine outcomes data gathered by the service, evaluating its effectiveness. Data from nine women with fertility problems that took part in the programme were analysed. They completed measures of wellbeing and psychological distress before and after the treatment. The results showed clinically significant improvements in participants' wellbeing scores and psychological distress. It was a limitation of the study that the impact of concurrent treatments could not be assessed and so could also have contributed to this outcome in half of the cases. Nevertheless, these results suggest that MBCT may be a helpful treatment for women presenting with fertility-related distress.
Mindfulness-based interventions for women with breast cancer: an updated systematic review and meta-analysis. [2022]The aim of this meta-analysis was to systematically update the evidence for mindfulness-based stress reduction (MBSR) and mindfulness-based cognitive therapy (MBCT) in women with breast cancer.
The effect of mindfulness-based therapy on symptoms of anxiety and depression in adult cancer patients and survivors: a systematic review and meta-analysis. [2022]The use of mindfulness-based therapy (MBT) in oncology settings has become increasingly popular, and research in the field has rapidly expanded. The objective was by means of a systematic review and meta-analysis to evaluate the current evidence for the effect of MBT on symptoms of anxiety and depression in adult cancer patients and survivors.
Mindfulness-based interventions: an overall review. [2021]This is an overall review on mindfulness-based interventions (MBIs).
Adverse or therapeutic? A mixed-methods study investigating adverse effects of Mindfulness-Based Cognitive Therapy in bipolar disorder. [2021]Mindfulness-Based Interventions (MBIs) are widely used in clinical and non-clinical populations, but little attention has been given to potential adverse effects (AEs).
Association of Mindfulness-Based Interventions With Anxiety Severity in Adults With Cancer: A Systematic Review and Meta-analysis. [2020]Mindfulness-based interventions (MBIs), grounded in mindfulness, focus on purposely paying attention to experiences occurring at the present moment without judgment. MBIs are increasingly used by patients with cancer for the reduction of anxiety, but it remains unclear if MBIs reduce anxiety in patients with cancer.
Mindfulness-Based Stress Reduction for Health Care Staff: Expanding Holistic Nursing Paradigms to the Whole System. [2021]Mindfulness-based stress reduction (MBSR) is a well-known mindfulness meditation program for patients that also may benefit health care providers and clinic staff themselves. An abbreviated MBSR program adapted into 6 weekly 75-minute sessions held during staff lunch breaks provided a feasible and acceptable staff training approach within the workplace setting.
Mindfulness-based stress reduction: a non-pharmacological approach for chronic illnesses. [2022]Mindfulness Based Stress Reduction (MBSR) therapy is a meditation therapy, though originally designed for stress management, it is being used for treating a variety of illnesses such as depression, anxiety, chronic pain, cancer, diabetes mellitus, hypertension, skin and immune disorders.
A single-blind, randomized, pilot study of a brief mindfulness-based intervention for the endometriosis-related pain management. [2022]Women with endometriosis suffer from frequent symptoms despite multiple treatments in tertiary care. Although there is a need for a biopsychosocial perspective on endometriosis treatment, few conservative treatments have been investigated. We aimed to investigate the effects of a brief Mindfulness-Based Intervention (bMBI) in women with deep endometriosis who remain symptomatic despite undergoing conventional medical treatment.
Cognitive-affective changes mediate the mindfulness-based intervention effect on endometriosis-related pain and mental health: A path analysis approach. [2023]There is poor knowledge about the therapeutic mechanisms of the conservative interventions for endometriosis. We hypothesized that the effects of a brief mindfulness-based intervention (bMBI) on pelvic pain intensity (PPI), pain unpleasantness (PU) and quality of life mental health (QoL-MH) are mediated by direct and indirect paths of changes in pain catastrophizing (PC), positive affect (PA) and negative affect (NA).
Psychological and mind-body interventions for endometriosis: A systematic review. [2020]Endometriosis is a common gynecological condition associated with debilitaing pain and poor mental health. This review examines the evidence for psychological and mind-body (PMB) interventions to improve endometriosis pain, psychological distress, sleep and fatigue. Electronic databases searched included PsychINFO, MEDLINE, CINAHL, EMBASE, Cochrane Library, Scopus, and PubMed. Inclusion criteria were women with endometriosis, and interventions that used psychological or mind-body interventions; there were no exclusion criteria regarding study design. Studies were identified and coded using standard criteria, and risk of bias was assessed with established tools relevant to the study design. A total of 12 publications relating to 9 separate studies were identified:- 3 randomized controlled trials, 1 controlled trial, 2 single-arm studies, 1 retrospective cohort study, and 2 case series. Interventions included yoga, mindfulness, relaxation training, cognitive behavioural therapy combined with physical therapy, Chinese medicine combined with psychotherapy, and biofeedback. Results indicate that no studies have yet used gold-standard methodology and, thus, definitive conclusions cannot be offered about PMB efficacy. However, the results of these pilot studies suggest that PMB interventions show promise in alleviating pain, anxiety, depression, stress and fatigue in women with endometriosis, and future well-designed RCTs including active control groups are warranted.
Mindfulness intervention effect on endometriosis-related pain dimensions and its mediator role on stress and vitality: a path analysis approach. [2023]Endometriosis-related pain is supposedly mainly responsible for generating psychological stress and deteriorating the quality of life. However, the interaction between these factors has not been investigated, considering its multidimensional nature and through the path of effects of psychosocial approaches. The present study aims to investigate the effect of a brief mindfulness-based intervention (bMBI) on pain dimensions and its mediator role on psychological stress and QoL-Vitality improvement. A secondary analysis of a pilot randomized controlled trial using a series of parallel and serial mediators was carried out. The results showed that bMBI improves the sensory (B = -6.09 [-9.81, -2.52], β = -0.42) and affective (B = -3.40 [-5.02, -1.80], β = -0.47) pain. The bMBI effect on psychological stress reduction was mediated by these changes in sensory (B = -2.81 [-6.06, -0.41], β = -0.21) and affective (B = -1.97 [-5.07, -0.17], β = -0.15) pain. Serial sensory pain and psychological stress reduction (B = 2.27 [0.11, 5.81], β = -0.09) mediated the bMBI effect on quality of life vitality. Meditation training promotes additional improvement in affective and sensory pain characteristics through which psychological stress is reduced. The sensory pain dimension must be positively impacted in combination with psychological stress for the bMBI improves women's vitality. Adding a psychosocial intervention like meditation training to the standard treatment plan may be required for some women to achieve the needed changes to restore well-being.
Behavioral, cognitive, and emotional coping strategies of women with endometriosis: a critical narrative review. [2018]Endometriosis is a disabling and long-term medical condition affecting quality of life and mental health. Behavioral, cognitive, and emotional coping strategies, emotional intelligence, and metacognition could in part explain the link between the disease and impaired psychological and life functioning. This critical narrative review aimed at examining the state of the art of the relationships between endometriosis and these factors. According to PRISMA principles, we performed a systematic search for quantitative and qualitative studies on multiple electronic databases as regards coping strategies, emotional intelligence, and metacognition in women with endometriosis. Studies were subjected to interpretative and critical narrative synthesis. A total of 9 papers were included in the review. Three main categories were identified in thematic analysis and resumed in the manuscript. Findings suggested that (a) pain is considered the major stressor; (b) they usually use both adaptive and maladaptive coping strategies; (c) women with endometriosis and related chronic pain seem to repress emotions more likely than healthy ones; (d) suppressing own emotions, pain catastrophizing, and having a passive coping style are related to higher self-reported pain; and (e) emotional and avoidance coping styles are associated to poor mental status, while positive coping strategies focusing on the problem or on emotions, detached and rational styles are associated to better mental health. Few studies with mixed results and some methodological flaws have focused on coping strategies in women with endometriosis. No studies focusing on metacognition or emotional intelligence were found. Methodological biases, suggestions for future research, and implications for clinical practice were discussed.