Claustrophobia and Magnetic Resonance Imaging

Claustrophobia Clinical Trial

— CLAUSTRO  

Official title:

Reduction of Claustrophobia During Magnetic Resonance Imaging: Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00715806
• Other study ID #: EA1/020/08
• Status: Completed
• Phase: N/A
• First received: July 10, 2008
• Last updated: June 21, 2011
• Start date: June 2008
• Est. completion date: August 2009

Study information

• Verified date: November 2009
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The objective of the study is to determine the ability of open magnetic resonance imaging (MRI) scanners to reduce claustrophobic reactions, thereby enabling more examinations of severely anxious patients. The investigators hypothesize that anxiety-based claustrophobia that prevents MR examinations without sedation can be reduced using an open MR scanner design thereby improving clinical management of those patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Severely anxious patients with reported claustrophobia during MRI or with the inability to undergo MR examinations on conventional scanners

• Clinical indication for MR imaging of the head, spine, or shoulder.

Exclusion Criteria:

• Contraindication to MR imaging (shrapnells, pacemakers, certain unsafe implants)

• Age below 18 years

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Claustrophobia
• Phobic Disorders

Intervention

Device:
• Open MRI scanner.
Imaging in an Open MRI scanner.
• Closed MRI scanner.
Imaging in a short-bore closed MRI scanner.

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 (3)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The ability of an open MRI scanner to reduce claustrophobic reactions that prevent MR examinations.		Before or During MRI	Yes
Secondary	Impact of MR imaging results on subsequent measurement.		6 months after MRI	No

External Links

•   Radiology at Charité