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

July 10, 2008
June 21, 2011
June 2008
August 2009   (final data collection date for primary outcome measure)
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 ]
The ability of an open MRI scanner to reduce claustrophobic reactions that prevent MR examinations. [ Time Frame: During MRI ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00715806 on ClinicalTrials.gov Archive Site
Impact of MR imaging results on subsequent measurement. [ Time Frame: 6 months after MRI ] [ Designated as safety issue: No ]
Influence of MR imaging results on further clinical management, cost-effectiveness, image quality achieved using the two scanners, and patient acceptance and preference in regards to the diagnostic procedure in the two randomized study groups. [ Time Frame: During or after MRI. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Claustrophobia and Magnetic Resonance Imaging
Reduction of Claustrophobia During Magnetic Resonance Imaging: Randomized, Controlled Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Claustrophobia
  • Device: Open MRI scanner.
    Imaging in an Open MRI scanner.
  • Device: Closed MRI scanner.
    Imaging in a short-bore closed MRI scanner.
  • Experimental: 1
    Intervention: Device: Open MRI scanner.
  • Active Comparator: 2
    Intervention: Device: Closed MRI scanner.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
174
August 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00715806
EA1/020/08
No
Marc Dewey, Charité
Charite University, Berlin, Germany
Not Provided
Principal Investigator: Marc Dewey, MD Charité
Charite University, Berlin, Germany
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP