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Claustrophobia and Magnetic Resonance Imaging (CLAUSTRO)

This study has been completed.
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00715806
First received: July 10, 2008
Last updated: June 21, 2011
Last verified: November 2009
History of Changes
  Purpose

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
Claustrophobia
 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:

MedlinePlus related topics: Anxiety MRI Scans
U.S. FDA Resources

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.

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00715806

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

Additional Information:
Radiology at Charité  This link exits the ClinicalTrials.gov site

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Marc Dewey, Charité
ClinicalTrials.gov 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:
claustrophobia
magnetic resonance imaging
MRI
 anxiety
open design
severely anxious patients

Additional relevant MeSH terms:
Phobic Disorders
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013