Claustrophobia and Magnetic Resonance Imaging (CLAUSTRO)
June 21, 2011 updated by: Charite University, Berlin, Germany
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
174
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Berlin, Germany, 10117
- Charité
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
|
Imaging in an Open MRI scanner.
|
|
Active Comparator: 2
|
Imaging in a short-bore closed MRI scanner.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The ability of an open MRI scanner to reduce claustrophobic reactions that prevent MR examinations.
Time Frame: Before or During MRI
|
Before or During MRI
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Impact of MR imaging results on subsequent measurement.
Time Frame: 6 months after MRI
|
6 months after MRI
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Marc Dewey, MD, Charité
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. doi: 10.1002/jmri.21147.
- 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. doi: 10.1016/j.ejrad.2007.01.025. Epub 2007 Mar 23.
- Enders J, Zimmermann E, Rief M, Martus P, Klingebiel R, Asbach P, Klessen C, Diederichs G, Bengner T, Teichgraber 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.
- Enders J, Rief M, Zimmermann E, Asbach P, Diederichs G, Wetz C, Siebert E, Wagner M, Hamm B, Dewey M. High-field open versus short-bore magnetic resonance imaging of the spine: a randomized controlled comparison of image quality. PLoS One. 2013 Dec 31;8(12):e83427. doi: 10.1371/journal.pone.0083427. eCollection 2013.
- Enders J, Zimmermann E, Rief M, Martus P, Klingebiel R, Asbach P, Klessen C, Diederichs G, Wagner M, Teichgraber U, Bengner T, Hamm B, Dewey M. Reduction of claustrophobia with short-bore versus open magnetic resonance imaging: a randomized controlled trial. PLoS One. 2011;6(8):e23494. doi: 10.1371/journal.pone.0023494. Epub 2011 Aug 22.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
August 1, 2009
Study Completion (Actual)
August 1, 2009
Study Registration Dates
First Submitted
July 10, 2008
First Submitted That Met QC Criteria
July 11, 2008
First Posted (Estimate)
July 15, 2008
Study Record Updates
Last Update Posted (Estimate)
June 23, 2011
Last Update Submitted That Met QC Criteria
June 21, 2011
Last Verified
November 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EA1/020/08
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.