Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2026-01-01 @ 5:59 PM
Study NCT ID:
NCT07132359
Status:
COMPLETED
Last Update Posted:
2025-08-20
First Post:
2025-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Body Image in the Relationship Between Pregnant Women's Sexuality and Sexual Stress
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 422}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2025-07-25', 'studyFirstSubmitQcDate': '2025-08-19', 'lastUpdatePostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '"Attitude Scale toward Sexuality during Pregnancy Scale"', 'timeFrame': '3 months', 'description': 'It was conducted with 422 pregnant women. Their written and verbal consent was obtained.\n\nThe Attitude Scale toward Sexuality during Pregnancy: The scale consists of 34 items and three sub-dimensions. The score range of the scale is 34-170. An increase in the scale total score indicates that attitudes toward sexuality during pregnancy are positive.'}, {'measure': 'The Female Sexual Distress Scale-Revised', 'timeFrame': '3 months', 'description': 'The scale consists of 13 items to evaluate different aspects of distress related to sexual activity in women. The lowest score that can be obtained from the scale is 0, and the highest is 52. Higher scores indicate higher levels of sexual distress.'}, {'measure': 'The Body Understanding Measure for Pregnancy Scale', 'timeFrame': '3 months', 'description': 'The scale consists of 18 items and three sub-dimensions: pregnancy appearance, concerns about weight gain, and physical burden of pregnancy. The score range of the scale is 20-100.As the score increases, the level of dissatisfaction with the perceived body image also increases.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Body image', 'attitude toward sexuality', 'sexual stress', 'pregnancy'], 'conditions': ['Women (Between 18 to 50 Years Old)']}, 'referencesModule': {'references': [{'pmid': '37272411', 'type': 'BACKGROUND', 'citation': 'Batuhan Karasin F, Yilmaz T. Psychometric properties of the Turkish version of BUMPs and its relationship with prenatal attachment. J Reprod Infant Psychol. 2025 Jan;43(1):62-75. doi: 10.1080/02646838.2023.2217718. Epub 2023 Jun 5.'}]}, 'descriptionModule': {'briefSummary': "Sexual activity is negatively affected during pregnancy. In addition process of adapting to the changes in the pregnant woman's body negatively affects her psychology. Therefore, pregnant woman's perception of her body image can lead to sexual stress. This study aimed to determine the mediating role of body image perception in the relationship between pregnant women's attitudes toward sexuality and their sexual stress. The study sample consisted of 422 pregnant women.", 'detailedDescription': 'Sexual activity is negatively affected during pregnancy. In addition process of adapting to the changes in the pregnant woman\'s body negatively affects her psychology. Therefore, pregnant woman\'s perception of her body image can lead to sexual stress. This study aimed to determine the mediating role of body image perception in the relationship between pregnant women\'s attitudes toward sexuality and their sexual stress. The study sample consisted of 422 pregnant women. Data collection tools included a "Personal Information Form," the "Attitude Scale toward Sexuality during Pregnancy," the "Female Sexual Distress Scale-Revised" and the "Body Understanding Measure for Pregnancy Scale."'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The population of the study consisted of pregnant women over the age of 20 who presented to the obstetrics and gynecology clinic. During the study, 440 pregnant women were reached. Twelve of them dropped out of the study, and six preferred to have their follow-up at a different hospital; therefore, they were not included in the study. Eventually, the study sample consisted of 422 pregnant women.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Volunteering to participate in the study\n* Having no communication problems\n* Being at the ≥10th weeks of gestation\n* Scoring ≥11.5 on the Female Sexual Distress Scale-Revised\n\nExclusion Criteria:\n\n* Refusing to participate in the study\n* Having been diagnosed with a sexual dysfunction before pregnancy\n* Having psychological health problems according to medical records'}, 'identificationModule': {'nctId': 'NCT07132359', 'acronym': 'pregnancy', 'briefTitle': "Role of Body Image in the Relationship Between Pregnant Women's Sexuality and Sexual Stress", 'organization': {'class': 'OTHER', 'fullName': 'University of Gaziantep'}, 'officialTitle': "The Mediating Role of Body Image Perception in the Relationship Between Pregnant Women's Attitudes Toward Sexuality and Their Sexual Stress", 'orgStudyIdInfo': {'id': 'GAUN-EBE-EKD-04'}}, 'armsInterventionsModule': {'interventions': [{'name': 'The Body Understanding Measure for Pregnancy Scale', 'type': 'OTHER', 'description': 'During the study, the purpose of the study was explained to the pregnant women, and it was stated that participation in the study was completely voluntary and that they could leave the study at any time, and their written and verbal consent was obtained (Informed Consent Form). Pregnant women who agreed to participate in the study filled out the data collection forms individually.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gaziantep', 'country': 'Turkey (Türkiye)', 'facility': 'Gaziantep University', 'geoPoint': {'lat': 37.05944, 'lon': 37.3825}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Gaziantep', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asisstant Professor Obstetrics and Gynecology Nursing', 'investigatorFullName': 'Ece Kaplan', 'investigatorAffiliation': 'University of Gaziantep'}}}}