Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT05297435
Status:
COMPLETED
Last Update Posted:
2022-03-28
First Post:
2022-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Psychotraumatology in Somatic Medicine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-25', 'studyFirstSubmitDate': '2022-03-11', 'studyFirstSubmitQcDate': '2022-03-25', 'lastUpdatePostDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of physician-patient relationship', 'timeFrame': 'Day 0', 'description': 'German version of the questionnaire "Patient Reactions Assessment Instruments" (PRA-D; Brenk-Franz et al., 2016)'}], 'secondaryOutcomes': [{'measure': 'Early traumatization', 'timeFrame': 'Day 0', 'description': 'German version of the questionnaire "Childhood Trauma Questionnaire" (CTQ, Bernstein und Fink, 1998)'}, {'measure': 'Current traumatization', 'timeFrame': 'Day 0', 'description': 'German version of the questionnaire "Impact of Event Scale-Revised" (IES-R; Weiss \\& Marmar, 1997)'}, {'measure': 'Anxiety & Depression', 'timeFrame': 'Day 0', 'description': 'German version of the questionnaire "Hospital Anxiety and Depression Scale" (HADS; Herrmann et al., 1995; Hermann-Lingen et al., 2011)'}, {'measure': 'Dissociative symptoms', 'timeFrame': 'Day 0', 'description': 'German questionnaire on dissociative symptoms (FDS-20; Spitzer et al., 2021)'}, {'measure': 'General distress', 'timeFrame': 'Day 0', 'description': 'German version of the questionnaire "distress thermometer" (BTH; Mehnert et al., 2006)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Trauma, Psychological; Somatic']}, 'descriptionModule': {'briefSummary': 'Psychotraumatology is clinically highly relevant, especially in the medical-somatic disciplines. Despite progress in recent decades, the clinical care is still inadequate - with unfavorable health effects for affected patients. There are avoidable burdens for involved clinicians and the health care system as a whole, also in terms of costs. With this background, our long-term project combines different research levels. Besides clarifying the clinical phenomenon, it aims to examine 1) the influence of traumatization on the physician-patient interaction as well as 2) the current psychological stress of the patients. Furthermore, 3) moderating factors on the side of the physicians, such as professional experience on the physician-patient interaction will be examined.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Female patients of the preventive consultation of the gynecological clinic of the cantonal hospital St.Gallen', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years old\n* Female patients of the preventive consultation of the gynecological clinic of the cantonal hospital St.Gallen\n\nExclusion Criteria:\n\n* Severe mental disorder (e.g. dissociative disorder)\n* Insufficient knowledge of German'}, 'identificationModule': {'nctId': 'NCT05297435', 'briefTitle': 'Psychotraumatology in Somatic Medicine', 'organization': {'class': 'OTHER', 'fullName': 'Cantonal Hospital of St. Gallen'}, 'officialTitle': 'Psychotraumatology in Somatic Medicine - Gynecological Consultation', 'orgStudyIdInfo': {'id': '2020-02551'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Questionnaires', 'type': 'DIAGNOSTIC_TEST', 'description': 'Questionnaire study'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9007', 'city': 'Sankt Gallen', 'country': 'Switzerland', 'facility': 'Katja Haemmerli Keller', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cantonal Hospital of St. Gallen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. phil.', 'investigatorFullName': 'Katja Haemmerli Keller', 'investigatorAffiliation': 'Cantonal Hospital of St. Gallen'}}}}