Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2025-12-26 @ 1:39 PM
Study NCT ID:
NCT01367067
Status:
COMPLETED
Last Update Posted:
2021-08-06
First Post:
2011-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prediction of Claustrophobia During MR Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098452', 'term': 'Claustrophobia'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-02', 'studyFirstSubmitDate': '2011-05-31', 'studyFirstSubmitQcDate': '2011-06-03', 'lastUpdatePostDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The mean score of the Claustrophobia Questionnaire for the prediction of a claustrophobic event during MR imaging', 'timeFrame': 'Up to 5 min after the end of the MR'}], 'secondaryOutcomes': [{'measure': 'Identification of specific psychometric questions for the prediction of a claustrophobic event during MR imaging', 'timeFrame': 'Up to 5 min after the end of the MR'}, {'measure': 'Identification of influential factors for the prediction of a claustrophobic event', 'timeFrame': 'Up to 5 min after the end of the MR'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['claustrophobia', 'magnetic resonance imaging', 'MRI', 'anxiety', 'anxious patients', 'phobic disorders', 'anxiety disorders', 'mental disorders'], 'conditions': ['Claustrophobia']}, 'referencesModule': {'references': [{'pmid': '17969166', 'type': 'BACKGROUND', 'citation': 'Dewey M, Schink T, Dewey CF. Claustrophobia during magnetic resonance imaging: cohort study in over 55,000 patients. J Magn Reson Imaging. 2007 Nov;26(5):1322-7. doi: 10.1002/jmri.21147.'}, {'pmid': '17383136', 'type': 'BACKGROUND', 'citation': 'Dewey M, Schink T, Dewey CF. Frequency of referral of patients with safety-related contraindications to magnetic resonance imaging. Eur J Radiol. 2007 Jul;63(1):124-7. doi: 10.1016/j.ejrad.2007.01.025. Epub 2007 Mar 23.'}, {'pmid': '21310075', 'type': 'BACKGROUND', 'citation': 'Enders J, Zimmermann E, Rief M, Martus P, Klingebiel R, Asbach P, Klessen C, Diederichs G, Bengner T, Teichgraber U, Hamm B, Dewey M. Reduction of claustrophobia during magnetic resonance imaging: methods and design of the "CLAUSTRO" randomized controlled trial. BMC Med Imaging. 2011 Feb 10;11:4. doi: 10.1186/1471-2342-11-4.'}, {'pmid': '27892781', 'type': 'RESULT', 'citation': 'Napp AE, Enders J, Roehle R, Diederichs G, Rief M, Zimmermann E, Martus P, Dewey M. Analysis and Prediction of Claustrophobia during MR Imaging with the Claustrophobia Questionnaire: An Observational Prospective 18-month Single-Center Study of 6500 Patients. Radiology. 2017 Apr;283(1):148-157. doi: 10.1148/radiol.2016160476. Epub 2016 Nov 25.'}], 'seeAlsoLinks': [{'url': 'http://radiologie.charite.de/', 'label': 'Radiology at Charité'}]}, 'descriptionModule': {'briefSummary': 'The objective of the study is to search for possible predictors for claustrophobia during magnetic resonance (MR) imaging. A claustrophobic event shall be defined by an incomplete examination, or a complete examination that requires coping actions by the staff. Coping actions may consist of the administration of sedatives, prism glasses, an MR imaging test run with the patient, a pause, the prone position, an escort in the scanner room, and supportive communication. The investigators hypothesize that there is a difference between patients with and without events in their scores on the Claustrophobia Questionnaire and several further psychometric questions. Other factors may also favour events like patient characteristics, examined region, duration of the examination and scanner type. Therefore, predictors could identify patients who are likely to experience claustrophobia during MR imaging so that they can receive the appropriate support by the staff to complete their examination. Thus a larger patient population could benefit from MR imaging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult inpatients and outpatients with a clinical indication of any part of the body who are referred to Charité for MR imaging', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inpatients and outpatients referred to MR imaging with a clinical indication of any part of the body\n* Mentally and physically able to fill out a questionnaire\n* Sufficient German language skills\n\nExclusion Criteria:\n\n* Age under 18 years\n* Patients from the Intensive Care Unit\n* Severe emergencies\n* Surgery during MR imaging\n* Participation in other studies\n* Fetal and prenatal examinations\n* Referral from medical jurisprudence'}, 'identificationModule': {'nctId': 'NCT01367067', 'acronym': 'CLAUSTRO II', 'briefTitle': 'Prediction of Claustrophobia During MR Imaging', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Prediction of Claustrophobia During MR Imaging: An Observational 18-Months Single Center Study', 'orgStudyIdInfo': {'id': 'EA1/020/08/E'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Psychometric Questionnaire', 'description': 'Adult inpatients and outpatients with a clinical indication of any part of the body who have been referred to Charité for MR imaging and have filled out a psychometric questionnaire'}, {'label': 'No Psychometric Questionnaire', 'description': 'Adult inpatients and outpatients with a clinical indication of any part of the body who have been referred to Charité for MR imaging and did not fill out a psychometric questionnaire'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Marc Dewey, PD Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charité'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Radiology', 'investigatorFullName': 'Marc Dewey', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}