Prediction of Claustrophobia During MR Imaging

Claustrophobia Clinical Trial

— CLAUSTRO II  

Official title:

Prediction of Claustrophobia During MR Imaging: An Observational 18-Months Single Center Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01367067
• Other study ID #: EA1/020/08/E
• Status: Completed
• Start date: January 2010
• Est. completion date: June 2011

Study information

• Verified date: August 2021
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8000
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Claustrophobia
• Phobic Disorders

Locations

Country	Name	City	State
Germany	Charité	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & 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. — View 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. Epub 2007 Mar 23. — View Citation

Enders J, Zimmermann E, Rief M, Martus P, Klingebiel R, Asbach P, Klessen C, Diederichs G, Bengner T, Teichgräber 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. — View 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 Patien — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Identification of influential factors for the prediction of a claustrophobic event		Up to 5 min after the end of the MR

External Links

•   Radiology at Charité