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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care for endometriosis surgery plus education | Active Comparator |
| |
| Standard of care for endometriosis surgery plus mindfulness | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pain education | Behavioral | Pain education |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Use of opioid medication | Morphine milligram equivalent following surgery | 1 week |
| Use of opioid medication | Morphine milligram equivalent following surgery | 3 months |
| Pain intensity | Numerical Pain Rating Scale 0-10, 10 being highest | 1 week |
| Pain intensity | Numerical Pain Rating Scale 0-10, 10 being highest | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep quality (sleep duration, awakenings, efficiency) | actigraphy monitoring | 1 week prior to surgery |
| Sleep quality (sleep duration, awakenings, efficiency) | actigraphy monitoring |
| Measure | Description | Time Frame |
|---|---|---|
| Pain threshold | Pain threshold | baseline |
| Temporal summation | Temporal summation of pain | baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christa Coleman | Contact | 717-531-8338 | ccoleman3@pennstatehealth.psu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Christa Coleman | Penn State Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Health | Recruiting | Hershey | Pennsylvania | 17033 | United States |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| mindfulness of pain introduction and intervention |
| Behavioral |
Brief mindfulness of pain introduction and intervention |
|
| 1 week following surgery |
| Sleep report | sleep diary (hours slept, activities during day and night) | 1 week following surgery |
| Sleep report | sleep diary (hours slept, activities during day and night) | 1 week prior to surgery |
| Emotional functioning | Hospital Anxiety and Depression Scale 0-21, 21 is worst | baseline |
| Emotional functioning | Hospital Anxiety and Depression Scale 0-21, 21 is worst | 1 week |
| Emotional functioning | Hospital Anxiety and Depression Scale 0-21, 21 is worst | 3 months |
| Patient global impression of change | Global Impression of change 1-7, 1 is best | 3 months |
| Patient global impression of change | Global Impression of change 1-7, 1 is best | 1 week |
| Pain catastrophizing | Pain catastrophizing Scale 0-52, 52 is worst | baseline |
| Pain catastrophizing | Pain catastrophizing Scale 0-52, 52 is worst | 1 week |
| Pain catastrophizing | Pain catastrophizing Scale 0-52, 52 is worst | 3 months |
| Treatment satisfaction | Treatment satisfaction 0-10, 10 being best | 1 week |
| Treatment satisfaction | Treatment satisfaction 0-10, 10 being best | 3 months |
| Heart rate variability | brief HRV assessment baseline and during intervention | baseline |
| D000091662 | Genital Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |