Claustrophobia and Magnetic Resonance Imaging (CLAUSTRO)

This study has been completed.
Information provided by:
Charite University, Berlin, Germany Identifier:
First received: July 10, 2008
Last updated: June 21, 2011
Last verified: November 2009

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.

Condition Intervention
Device: Open MRI scanner.
Device: Closed MRI scanner.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Reduction of Claustrophobia During Magnetic Resonance Imaging: Randomized, Controlled Trial

Resource links provided by NLM:

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • The ability of an open MRI scanner to reduce claustrophobic reactions that prevent MR examinations. [ Time Frame: Before or During MRI ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Impact of MR imaging results on subsequent measurement. [ Time Frame: 6 months after MRI ] [ Designated as safety issue: No ]

Estimated Enrollment: 174
Study Start Date: June 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: Open MRI scanner.
Imaging in an Open MRI scanner.
Active Comparator: 2 Device: Closed MRI scanner.
Imaging in a short-bore closed MRI scanner.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00715806

Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Principal Investigator: Marc Dewey, MD Charité
  More Information

Additional Information:
Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Marc Dewey, Charité Identifier: NCT00715806     History of Changes
Other Study ID Numbers: EA1/020/08
Study First Received: July 10, 2008
Last Updated: June 21, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
magnetic resonance imaging
open design
severely anxious patients

Additional relevant MeSH terms:
Phobic Disorders
Anxiety Disorders
Mental Disorders processed this record on October 08, 2015