Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-01-01 @ 8:12 PM
Study NCT ID:
NCT05596604
Status:
COMPLETED
Last Update Posted:
2022-10-27
First Post:
2022-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"Awareness, Preconception, and Fear of Epidural Analgesia Among Childbearing Women in Saudi Arabia."
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048949', 'term': 'Labor Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 202}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-24', 'studyFirstSubmitDate': '2022-10-24', 'studyFirstSubmitQcDate': '2022-10-24', 'lastUpdatePostDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Awareness', 'timeFrame': 'month', 'description': 'assess awareness among participants'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Awareness, preconception, fear, epidural analgesia, labor pain'], 'conditions': ['Assess Women Awareness and Fear About EDA for Labor']}, 'descriptionModule': {'briefSummary': 'The aim of our study is to measure the level of awareness, preconceptions, and level of fear regarding epidural analgesia among childbearing women in KKUH in Riyadh.', 'detailedDescription': 'This research was designed as a hospital-based observational cross-sectional study conducted at King Khalid University Hospital, using a self-administered questionnaire based on previous research.22-24-26 approved by the Institutional Review Board at King Saud University, College of Medicine, Riyadh, Saudi Arabia on 08.August.2022 Ref. No. 22/0592/IRB. The sample included pregnant women attending an obstetrical clinic for routine antenatal follow-up, and the data collection was conducted during the month of August 2022. The questionnaire included five parts (sociodemographic, preconception, awareness, fear, and desirability). a total of 26 questions with multiple-choice answers. The sample size was determined using the Comrey and Lee criterion Comrey and Lee (1992) stated that a 200-sample size is acceptable. The questionnaire was completed by 202 participants who met the inclusion criteria that is being a pregnant woman and completing the survey, and the exclusion criteria were non-pregnant women and an incomplete survey. The data collectors made it clear to the participants that taking part in the study was completely optional, and the participants signed anonymous consent forms.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'included pregnant women attending an obstetrical clinic for routine antenatal follow-up', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregnant woman\n* completing the survey\n\nExclusion Criteria:\n\n* non-pregnant women\n* incomplete survey'}, 'identificationModule': {'nctId': 'NCT05596604', 'briefTitle': '"Awareness, Preconception, and Fear of Epidural Analgesia Among Childbearing Women in Saudi Arabia."', 'organization': {'class': 'OTHER', 'fullName': 'King Khalid University Hospital'}, 'officialTitle': '"Awareness, Preconception, and Fear of Epidural Analgesia Among Childbearing Women in Saudi Arabia."', 'orgStudyIdInfo': {'id': '4361020'}}, 'armsInterventionsModule': {'interventions': [{'name': 'survey- no intervention', 'type': 'OTHER', 'description': 'survey- no intervention'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'King Khalid Medical City', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'we are not planning to share data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Khalid University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'King Saud University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'general practitioner', 'investigatorFullName': 'Abdulrhman Alshihri', 'investigatorAffiliation': 'King Khalid University Hospital'}}}}