Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2025-12-29 @ 1:36 PM
Study NCT ID:
NCT05990361
Status:
COMPLETED
Last Update Posted:
2023-11-28
First Post:
2023-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sexual Function, Body Image, Kinesiophobia and Physical Activity in Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059388', 'term': 'Pelvic Girdle Pain'}, {'id': 'D000092442', 'term': 'Kinesiophobia'}], 'ancestors': [{'id': 'D059352', 'term': 'Musculoskeletal Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017699', 'term': 'Pelvic Pain'}, {'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-27', 'studyFirstSubmitDate': '2023-05-09', 'studyFirstSubmitQcDate': '2023-08-11', 'lastUpdatePostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pregnancy Sexual Response Inventory-Turkish version', 'timeFrame': 'immediately before the clinical diagnostic tests will be applied the questionnaire', 'description': 'to assess sexual functions in pregnant women with and without PGP'}, {'measure': 'Body Image in Pregnancy Scale (BIPS-Turkish)', 'timeFrame': 'immediately before the clinical diagnostic tests will be applied the questionnaire', 'description': 'to evaluate body image perceptions of Turkish pregnant women with and without PGP'}, {'measure': 'Tampa Scale for Kinesiophobia-Turkish version', 'timeFrame': 'immediately before the clinical diagnostic tests will be applied the questionnaire', 'description': 'to evaluate level of kinesiophobia of Turkish pregnant women with and without PGP'}, {'measure': 'Pregnancy Physical Activity Questionnaire-Turkish version', 'timeFrame': 'immediately before the clinical diagnostic tests will be applied the questionnaire', 'description': 'To evaluate the physical activity level of pregnant women with and without PGP'}], 'secondaryOutcomes': [{'measure': 'Pelvic Girdle Questionnaire Pelvic Girdle Questionnaire-Turkish version', 'timeFrame': 'immediately after the clinical diagnostic tests for PGP will be applied the questionnaire', 'description': 'To evaluate both disability and symptoms women with pregnancy-related PGP'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pelvic girdle pain', 'sexual function', 'body image', 'fear of movement'], 'conditions': ['Pregnancy-Related Pelvic Girdle Pain']}, 'referencesModule': {'references': [{'pmid': '38981994', 'type': 'DERIVED', 'citation': 'Yenisehir S, Karakaya IC, Ozbey G. Sexual Function of Women with and without Pregnancy-Related Pelvic Girdle Pain and its Relationship with Physical Activity, Kinesiophobia and Body Image: A Cross-Sectional Comparative Study. Reprod Sci. 2024 Oct;31(10):3122-3131. doi: 10.1007/s43032-024-01644-2. Epub 2024 Jul 9.'}]}, 'descriptionModule': {'briefSummary': 'This study compares sexual function, body image, kinesiophobia and physical activity level in women with and without pregnancy-related pelvic girdle pain.', 'detailedDescription': "Pelvic girdle pain (PGP) is a condition felt around the posterior iliac crystals, gluteal region and the sacroiliac joints, may spread to the back of the thigh, and may occur together or separately with pain in the symphysis pubis. Pregnancy-related PGP causes problems in the sexual life of women. Body image differs with the development of physical symptoms and changes in body size and shape during pregnancy. Body dissatisfaction resulting from physical changes can cause problems in women's attitudes towards sexuality. Sexual function is affected by physiological, anatomical and psychological changes that occur during pregnancy. Sexual function during pregnancy has been associated with conditions such as body image, physical activity level, and pain.\n\nIn the literature, there are studies evaluating the relationship between sexual function and body image in pregnant women and in different populations. However, in these studies, questionnaires specific to pregnant women were not used to evaluate sexual function and body image, and a comparison of these parameters was not investigate in women with and without pregnancy-related PGP.\n\nTherefore, this study was planned to compare sexual function, body image, kinesiophobia and physical activity levels in women with and without pregnancy-related PGP.\n\nThe outcome measures are Pregnancy Sexual Response Inventory (PSRI), Body Image in Pregnancy Scale (BIPS-Turkish), Tampa Kinesiophobia Scale (TKS) and Pregnancy physical activity questionnaire (PPAQ).\n\nThe clinical diagnosis tests are Active Straight Leg Rise, Posterior Pelvic Pain Provocation Test, Long Dorsal Sacroiliac Ligament Palpation, Pelvic Compression, Pelvic Distraction, Patrick-Faber Test and Gaenslen Test."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women with and without pregnancy-related pelvic girdle pain', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being between 18 and 40 years-old,\n* Being second or third trimester of pregnancy\n* Being literate in Turkish\n\nExclusion Criteria:\n\n* Having a pregnancy complication (preeclampsia, pregnancy-induced hypertension, diabetes, etc.),\n* Having a known gynecological or urological problem that may mimic PGP\n* Having neurological (multiple sclerosis, spinal cord injury, etc.), orthopedic (hip dislocation, etc.), cardiopulmonary (heart failure, chronic obstructive pulmonary disease, etc.) problems that affect sexual function and physical activity,\n* Having situations in which sexual activity is contraindicated and should be restricted (placenta previa, risk of premature birth, cervical insufficiency, antepartum hemorrhage, premature rupture of membranes, genital infection, etc.),\n* Having visual, auditory and cognitive problems that may prevent participation in the study.'}, 'identificationModule': {'nctId': 'NCT05990361', 'briefTitle': 'Sexual Function, Body Image, Kinesiophobia and Physical Activity in Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'Muş Alparslan University'}, 'officialTitle': "Comparison of Sexual Function, Body Image, Kinesiophobia and Physical Activity Level in Women With and Without Pregnancy-related Pelvic Girdle Pain''", 'orgStudyIdInfo': {'id': '18.04.2023-90204'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'women with pelvic girdle pain', 'description': 'The subjects who have at least one positive result from Active Straight Leg Raise, and Posterior Pelvic Pain Provocation Tests; and at least two positive results from the Pelvic Compression and Distraction, Patrick Faber, Gaenslen and Long Dorsal Sacroiliac Ligament Palpation tests are classified as with PGP group.', 'interventionNames': ['Diagnostic Test: clinical diagnostic test']}, {'label': 'women without pelvic girdle pain', 'description': 'The subjects who have not at least one positive result from Active Straight Leg Raise, and Posterior Pelvic Pain Provocation Tests; and at least two positive results from the Pelvic Compression and Distraction, Patrick Faber, Gaenslen and Long Dorsal Sacroiliac Ligament Palpation tests are classified as without PGP group.', 'interventionNames': ['Diagnostic Test: clinical diagnostic test']}], 'interventions': [{'name': 'clinical diagnostic test', 'type': 'DIAGNOSTIC_TEST', 'description': 'The clinical diagnosis tests are Active Straight Leg Rise ASLR, Posterior Pelvic Pain Provocation, Long Dorsal Sacroiliac Ligament Palpation (LDSLP), Pelvic Compression, Pelvic Distraction, Patrick-Faber Test (PF), and Gaenslen Test (GT).\n\nThe subjects who had at least one positive result from ASLR and P4 Tests; and at least two positive results from the Pelvic Compression and Distraction, PF, GT and LDSLP tests are classified as with PGP group.', 'armGroupLabels': ['women with pelvic girdle pain', 'women without pelvic girdle pain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49000', 'city': 'Muş', 'country': 'Turkey (Türkiye)', 'facility': 'Semiha Yenişehir', 'geoPoint': {'lat': 38.73163, 'lon': 41.48482}}], 'overallOfficials': [{'name': 'SEMİHA YENİŞEHİR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Muş Alparslan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Muş Alparslan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}