Prediction of Claustrophobia During MR Imaging
CLAUSTRO II
1 other identifier
observational
8,000
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 31, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFirst Posted
Study publicly available on registry
June 6, 2011
CompletedAugust 6, 2021
August 1, 2021
1.4 years
May 31, 2011
August 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The mean score of the Claustrophobia Questionnaire for the prediction of a claustrophobic event during MR imaging
Up to 5 min after the end of the MR
Secondary Outcomes (2)
Identification of specific psychometric questions for the prediction of a claustrophobic event during MR imaging
Up to 5 min after the end of the MR
Identification of influential factors for the prediction of a claustrophobic event
Up to 5 min after the end of the MR
Study Arms (2)
Psychometric Questionnaire
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
No Psychometric Questionnaire
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
Eligibility Criteria
Adult inpatients and outpatients with a clinical indication of any part of the body who are referred to Charité for MR imaging
You may qualify if:
- Inpatients and outpatients referred to MR imaging with a clinical indication of any part of the body
- Mentally and physically able to fill out a questionnaire
- Sufficient German language skills
You may not qualify if:
- Age under 18 years
- Patients from the Intensive Care Unit
- Severe emergencies
- Surgery during MR imaging
- Participation in other studies
- Fetal and prenatal examinations
- Referral from medical jurisprudence
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Charité
Berlin, 10117, Germany
Related Publications (4)
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: 17969166BACKGROUNDDewey 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: 17383136BACKGROUNDEnders 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: 21310075BACKGROUNDNapp 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.
PMID: 27892781RESULT
Related Links
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Marc Dewey, PD Dr. med.
Charité
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Radiology
Study Record Dates
First Submitted
May 31, 2011
First Posted
June 6, 2011
Study Start
January 1, 2010
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
August 6, 2021
Record last verified: 2021-08