Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2025-12-26 @ 4:58 AM
Study NCT ID:
NCT07291466
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Preoperative Anxiety and Evaluation of Calming Interventions: Anonymous Patient Survey
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 480}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2025-11-20', 'studyFirstSubmitQcDate': '2025-12-04', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Capture patients' preferences for anxiety reduction", 'timeFrame': 'baseline', 'description': 'using multiple-choice and open-ended responses'}], 'secondaryOutcomes': [{'measure': "To assess patients' preoperative anxiety", 'timeFrame': 'baseline', 'description': 'Using the STOA questionnaire. The STOA evaluates anxiety on two levels: the long-term, personality-related tendency toward surgical anxiety (trait) and the current state of anxiety (state), with cognitive and affective components. The STOA-State scale includes 10 items rated on a 4-point scale from 0 ("Not at all") to 3 ("Very much"), yielding a total score of 0-30. The STOA-Trait scale includes 20 items rated from 0 ("Almost never") to 3 ("Almost always"), with a total score of 0-60.'}, {'measure': "To assess patients' preoperative anxiety", 'timeFrame': 'baseline', 'description': 'Using APAIS questionnaire. The APAIS is a validated, brief instrument with 20 items, assessing anxiety related to anesthesia and the surgical procedure. Anxiety scores range from 4 (no anxiety) to 20 (high anxiety), and the total score ranges from 6 to 30.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['operation, anxiety'], 'conditions': ['Anxiety']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to better understand the anxiety of patients before elective surgeries and to investigate which measures for calming are perceived as helpful or pleasant. Adult, German-speaking patients (≥18 years) in the elective surgical setting at UKB are invited to participate. It is planned that at least 400 patients will take part in the survey. The survey is conducted anonymously, voluntarily, and without the collection of personal data. This is a purely observational study without any intervention.', 'detailedDescription': 'Patients who come to the premedication outpatient clinic are invited in the waiting area to participate in this anonymous written survey. Participation is voluntary. The survey takes approximately 10-15 minutes. No personal data are collected.\n\nAnxiety is assessed using the State-Trait Operation Anxiety (STOA) and the Amsterdam Preoperative Anxiety and Information Scale (APAIS) questionnaires.\n\nTo address anxiety reduction, various possible measures are listed, and patients are asked to check all the options they consider helpful and appropriate. They are also given the opportunity to add further suggestions that are not included in the list.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult, German-speaking patients (≥18 years) in the elective surgical setting at UKB are invited to participate.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdults (≥18 years), German-speaking patients in the elective surgical setting\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07291466', 'acronym': 'anti-anxiety', 'briefTitle': 'Assessment of Preoperative Anxiety and Evaluation of Calming Interventions: Anonymous Patient Survey', 'organization': {'class': 'OTHER', 'fullName': 'University of Bonn'}, 'officialTitle': 'Erhebung Von präoperativer Ängstlichkeit Und Bewertung Beruhigender Maßnahmen: Anonyme Patientenbefragung', 'orgStudyIdInfo': {'id': '2025-290-BO'}}, 'contactsLocationsModule': {'locations': [{'zip': '53127', 'city': 'Bonn', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Tugce Dinc', 'role': 'CONTACT', 'email': 'tugce.dinc-dogan@ukbonn.de', 'phone': '004917681428765'}], 'facility': 'University of Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vera Guttenthaler', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'study coordinator', 'investigatorFullName': 'Vera Guttenthaler', 'investigatorAffiliation': 'University of Bonn'}}}}