Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-30 @ 12:00 PM
Study NCT ID:
NCT05915403
Status:
COMPLETED
Last Update Posted:
2023-06-23
First Post:
2023-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Frequency of Sexual Intercourse,Women With Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064232', 'term': 'Visual Analog Scale'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-21', 'studyFirstSubmitDate': '2023-06-12', 'studyFirstSubmitQcDate': '2023-06-21', 'lastUpdatePostDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale', 'timeFrame': '1 week', 'description': 'pain level 0-10, higher scores indicate worse outcome'}, {'measure': 'frequency of sexual intercourse', 'timeFrame': '3 mounths', 'description': 'mean monthly frequency of sexual intercourse in the last 3 months'}, {'measure': 'Fibromyalgia Impact Questionnaire', 'timeFrame': '1 week', 'description': '0-80, higher scores indicate worse outcome'}], 'secondaryOutcomes': [{'measure': 'Beck Depression Inventory', 'timeFrame': '1 week', 'description': '0-63, higher scores indicate worse outcome'}, {'measure': 'Widespread Pain Index', 'timeFrame': '1 week', 'description': '0-19, higher scores indicate worse outcome'}, {'measure': 'Symptom Severity Scale', 'timeFrame': '1 week', 'description': '0-12, higher scores indicate worse outcome'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fibromyalgia', 'Pain', 'Depression']}, 'referencesModule': {'references': [{'pmid': '27844312', 'type': 'RESULT', 'citation': 'Maunder L, Schoemaker D, Pruessner JC. Frequency of Penile-Vaginal Intercourse is Associated with Verbal Recognition Performance in Adult Women. Arch Sex Behav. 2017 Feb;46(2):441-453. doi: 10.1007/s10508-016-0890-4. Epub 2016 Nov 14.'}, {'pmid': '9949283', 'type': 'RESULT', 'citation': 'Blaicher W, Gruber D, Bieglmayer C, Blaicher AM, Knogler W, Huber JC. The role of oxytocin in relation to female sexual arousal. Gynecol Obstet Invest. 1999;47(2):125-6. doi: 10.1159/000010075.'}, {'pmid': '17109236', 'type': 'RESULT', 'citation': 'Burleson MH, Trevathan WR, Todd M. In the mood for love or vice versa? Exploring the relations among sexual activity, physical affection, affect, and stress in the daily lives of mid-aged women. Arch Sex Behav. 2007 Jun;36(3):357-68. doi: 10.1007/s10508-006-9071-1.'}, {'pmid': '21681120', 'type': 'RESULT', 'citation': 'Ainsworth BE, Haskell WL, Herrmann SD, Meckes N, Bassett DR Jr, Tudor-Locke C, Greer JL, Vezina J, Whitt-Glover MC, Leon AS. 2011 Compendium of Physical Activities: a second update of codes and MET values. Med Sci Sports Exerc. 2011 Aug;43(8):1575-81. doi: 10.1249/MSS.0b013e31821ece12.'}]}, 'descriptionModule': {'briefSummary': 'Does frequency of sexual intercourse affect symptom severity in female patients with fibromyalgia?'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'tertiary healthcare facility', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\* Female patient with fibromyalgia\n\nExclusion Criteria:\n\n* Uncontrollable systemic disease (cardiovascular, pulmonary, hepatic, renal, hematological),\n* Major psychiatric disease,\n* Endocrine disease,\n* Pregnancy\n* Menopausal status,\n* Antihypertensive, antidepressant, anxiolytic, antiepileptic drugs use'}, 'identificationModule': {'nctId': 'NCT05915403', 'briefTitle': 'Frequency of Sexual Intercourse,Women With Fibromyalgia', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Konya Beyhekim Training and Research Hospital'}, 'officialTitle': 'The Effect of Frequency of Sexual Intercourse on Symptoms in Women With Fibromyalgia', 'orgStudyIdInfo': {'id': '2021-01-05'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient', 'description': 'female patient with fibromyalgia', 'interventionNames': ['Diagnostic Test: Fibromyalgia Impact Questionnaire']}, {'label': 'healthy controls', 'description': 'women'}], 'interventions': [{'name': 'Fibromyalgia Impact Questionnaire', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Visual Analog Scale', 'Beck Depression Inventory', 'Widespread Pain Index', 'Symptom Severity Scale', 'frequency of sexual intercourse'], 'description': 'diagnostic tests', 'armGroupLabels': ['Patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42060', 'city': 'Konya', 'state': 'Selçuklu', 'country': 'Turkey (Türkiye)', 'facility': 'Konya Beyhekim Research and Training Hospital', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Konya Beyhekim Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical doctor', 'investigatorFullName': 'Savaş Karpuz', 'investigatorAffiliation': 'Konya Beyhekim Training and Research Hospital'}}}}