Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT06141720
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2023-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility of a Mindfulness Intervention for Endometriosis Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2023-11-15', 'studyFirstSubmitQcDate': '2023-11-15', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pain threshold', 'timeFrame': 'baseline', 'description': 'Pain threshold'}, {'measure': 'Temporal summation', 'timeFrame': 'baseline', 'description': 'Temporal summation of pain'}], 'primaryOutcomes': [{'measure': 'Use of opioid medication', 'timeFrame': '1 week', 'description': 'Morphine milligram equivalent following surgery'}, {'measure': 'Use of opioid medication', 'timeFrame': '3 months', 'description': 'Morphine milligram equivalent following surgery'}, {'measure': 'Pain intensity', 'timeFrame': '1 week', 'description': 'Numerical Pain Rating Scale 0-10, 10 being highest'}, {'measure': 'Pain intensity', 'timeFrame': '3 months', 'description': 'Numerical Pain Rating Scale 0-10, 10 being highest'}], 'secondaryOutcomes': [{'measure': 'Sleep quality (sleep duration, awakenings, efficiency)', 'timeFrame': '1 week prior to surgery', 'description': 'actigraphy monitoring'}, {'measure': 'Sleep quality (sleep duration, awakenings, efficiency)', 'timeFrame': '1 week following surgery', 'description': 'actigraphy monitoring'}, {'measure': 'Sleep report', 'timeFrame': '1 week following surgery', 'description': 'sleep diary (hours slept, activities during day and night)'}, {'measure': 'Sleep report', 'timeFrame': '1 week prior to surgery', 'description': 'sleep diary (hours slept, activities during day and night)'}, {'measure': 'Emotional functioning', 'timeFrame': 'baseline', 'description': 'Hospital Anxiety and Depression Scale 0-21, 21 is worst'}, {'measure': 'Emotional functioning', 'timeFrame': '1 week', 'description': 'Hospital Anxiety and Depression Scale 0-21, 21 is worst'}, {'measure': 'Emotional functioning', 'timeFrame': '3 months', 'description': 'Hospital Anxiety and Depression Scale 0-21, 21 is worst'}, {'measure': 'Patient global impression of change', 'timeFrame': '3 months', 'description': 'Global Impression of change 1-7, 1 is best'}, {'measure': 'Patient global impression of change', 'timeFrame': '1 week', 'description': 'Global Impression of change 1-7, 1 is best'}, {'measure': 'Pain catastrophizing', 'timeFrame': 'baseline', 'description': 'Pain catastrophizing Scale 0-52, 52 is worst'}, {'measure': 'Pain catastrophizing', 'timeFrame': '1 week', 'description': 'Pain catastrophizing Scale 0-52, 52 is worst'}, {'measure': 'Pain catastrophizing', 'timeFrame': '3 months', 'description': 'Pain catastrophizing Scale 0-52, 52 is worst'}, {'measure': 'Treatment satisfaction', 'timeFrame': '1 week', 'description': 'Treatment satisfaction 0-10, 10 being best'}, {'measure': 'Treatment satisfaction', 'timeFrame': '3 months', 'description': 'Treatment satisfaction 0-10, 10 being best'}, {'measure': 'Heart rate variability', 'timeFrame': 'baseline', 'description': 'brief HRV assessment baseline and during intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endometriosis', 'Pain', 'Mindfulness']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age 18 years or older\n2. diagnosis or probable diagnosis of endometriosis\n3. candidate for surgical procedure for endometriosis\n4. English speaking\n5. have access to wifi and email\n\nExclusion Criteria:\n\n1. prior formal mindfulness training\n2. Unable to consent'}, 'identificationModule': {'nctId': 'NCT06141720', 'briefTitle': 'Feasibility of a Mindfulness Intervention for Endometriosis Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Feasibility of a Mindfulness Intervention for Endometriosis Surgery', 'orgStudyIdInfo': {'id': '23397'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of care for endometriosis surgery plus education', 'interventionNames': ['Behavioral: pain education']}, {'type': 'EXPERIMENTAL', 'label': 'Standard of care for endometriosis surgery plus mindfulness', 'interventionNames': ['Behavioral: mindfulness of pain introduction and intervention']}], 'interventions': [{'name': 'pain education', 'type': 'BEHAVIORAL', 'description': 'Pain education', 'armGroupLabels': ['Standard of care for endometriosis surgery plus education']}, {'name': 'mindfulness of pain introduction and intervention', 'type': 'BEHAVIORAL', 'description': 'Brief mindfulness of pain introduction and intervention', 'armGroupLabels': ['Standard of care for endometriosis surgery plus mindfulness']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christa Coleman', 'role': 'CONTACT', 'email': 'ccoleman3@pennstatehealth.psu.edu', 'phone': '7175318338'}], 'facility': 'Penn State Health', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}], 'centralContacts': [{'name': 'Christa Coleman', 'role': 'CONTACT', 'email': 'ccoleman3@pennstatehealth.psu.edu', 'phone': '717-531-8338'}], 'overallOfficials': [{'name': 'Christa Coleman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn State Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Psychiatry and Behavioral Health', 'investigatorFullName': 'Christa Coleman', 'investigatorAffiliation': 'Milton S. Hershey Medical Center'}}}}