Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-03-10 @ 11:50 PM
Study NCT ID:
NCT03385603
Status:
WITHDRAWN
Last Update Posted:
2018-11-19
First Post:
2017-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Pain-related Fear in Sexual Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'An investigator who will not interact with study participants will perform the random intervention assignment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized to receive one of two treatments.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No individuals met eligibility or were enrolled.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-15', 'studyFirstSubmitDate': '2017-12-20', 'studyFirstSubmitQcDate': '2017-12-20', 'lastUpdatePostDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vaginal Pain sensitivity', 'timeFrame': '40 days', 'description': 'A change in pressure pain sensitivity at the vagina using a Wagner Digital Algometer.'}], 'secondaryOutcomes': [{'measure': 'Sexual function', 'timeFrame': '40 days', 'description': "Assessed using the Female Sexual Function Index (FSFI), a 19- item questionnaire that measures desire, arousal, lubrication, orgasm, satisfaction, and pain in women with pelvic pain. This measure has high internal consistency (Cronbach's alpha 0.91-0.97) and good test-retest reliability (r=0.79-0.90)."}, {'measure': 'Sexual Distress', 'timeFrame': '40 days', 'description': "Assessed using the Female Sexual Distress Scale-Revised (FSDS-R), a 13-item questionnaire that evaluates negative emotions about sexuality and sexual relations. The internal consistency of this measure is high (Cronbach's alpha 0.86- 0.94) with good test retest reliability (ICC= 0.74)."}, {'measure': 'Partner dynamics', 'timeFrame': '40 days', 'description': "Assessed using the Revised Dyadic Adjustment Scale(RDAS), a 14-item questionnaire that assesses three overarching dimensions of relationships, including Consensus, Satisfaction, and Cohesion. This measure has high internal consistency (Cronbach's alpha= 0.90)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sexual Pain Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is the evaluate the extent to which an intervention aimed at reducing pain-related fear affects sexual function and pain sensitivity compared to usual care.', 'detailedDescription': 'The overarching goal of this work is to identify the mechanisms underpinning sexual pain in women. Women with sexual pain exhibit higher vaginal pain sensitivity and lower levels of sexual desire and arousal compared to pain-free women. As a result of pain, sexual intercourse is avoided. Previous work in this area has examined a wide variety of interventions for sexual pain but has not examined how vaginal pain sensitivity and resulting sexual dysfunction may be mediated by pain-related fear. The study team proposes that a standardized exposure intervention that directly targets pain-related fear will in turn reduce vaginal pain sensitivity and translate to clinically meaningful changes in sexual function. The study team will assign women with sexual pain to receive a home-based, patient-controlled exposure intervention or standardized home-based home program. The specific aims of this proposal are: 1) To evaluate the extent to which pain-related fear mediates vaginal pain sensitivity in women with sexual pain; 2) To evaluate the extent to which graded exposure translates to changes in sexual function and partner dynamics. The completion of this work will provide us with a better understanding of the mechanisms underpinning sexual pain and specifically, how pain-related fear influences vaginal pain sensitivity and sexual function.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females with sexual pain \\>= 6 months\n* Appropriate to use vaginal dilators\n* The ability to read English and understand the informed consent form and screening questions\n* The ability and willingness to follow all requirements of the study including following all directions and completion of daily pain reports\n* Signed informed consent\n* Are sexually active (have had intercourse at least twice in the last 30 days)\n* Pain-related fear of intercourse greater than 50 on the numerical fear rating scale\n\nExclusion Criteria:\n\n* Physical, psychological and medical issues, encountered during routine care that are felt insufficient for trial participation (physician discretion), such as poor mental status or neurological deficit limiting participation physically or cognitively (Mini-mental state exam less than 20).\n* Women with sexual pain who are not sexually active (have not had intercourse at least twice in the last 30 days)\n* Participants who use narcotic pain medication\n* Participants diagnosed with a major depressive disorder\n* Participants who exhibit signs and symptoms of infection, malignancy, or other conditions identified by a member of the study team that may be contraindications to the use of dilators\n* Unable to readily access computer with Internet for reporting on daily fear levels and dilator size\n* Pain-related fear of intercourse less than 50 on the numerical fear rating scale\n* Women who are pregnant\n* Participants who report a history of sexual abuse or trauma.'}, 'identificationModule': {'nctId': 'NCT03385603', 'briefTitle': 'The Role of Pain-related Fear in Sexual Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'The Role of Pain-related Fear in Sexual Pain', 'orgStudyIdInfo': {'id': 'IRB201702214'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fear-based Dilator Progression group', 'description': 'Participants in this group will complete a home dilator program using levels of pain-related fear to progress through the program.', 'interventionNames': ['Device: Dilator', 'Behavioral: Fear-Based Questionnaires']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Dilator Progression Group', 'description': 'Participants in this group will complete a standard home program based on dilator manufacturer instructions for use.', 'interventionNames': ['Device: Dilator']}], 'interventions': [{'name': 'Dilator', 'type': 'DEVICE', 'description': 'Both groups will have a home program consisting of dilators which are progressive in size. The standard care group will use manufacturer instructions to progress in size of dilators, while the experimental group will use self-reported levels of fear to progress in size of dilators.', 'armGroupLabels': ['Fear-based Dilator Progression group', 'Standard Dilator Progression Group']}, {'name': 'Fear-Based Questionnaires', 'type': 'BEHAVIORAL', 'description': 'Series of questionnaires used to facilitate emotional awareness associated with vaginal and decreased sexual arousal.', 'armGroupLabels': ['Fear-based Dilator Progression group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32606', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'UF Health at Springhill', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Meryl Alappattu, DPT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}