Claustrophobia and Magnetic Resonance Imaging

NCT ID: NCT00715806

Last Updated: 2011-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Claustrophobia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Open MRI scanner.

Intervention Type DEVICE

Imaging in an Open MRI scanner.

2

Group Type ACTIVE_COMPARATOR

Closed MRI scanner.

Intervention Type DEVICE

Imaging in a short-bore closed MRI scanner.

Interventions

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Open MRI scanner.

Imaging in an Open MRI scanner.

Intervention Type DEVICE

Closed MRI scanner.

Imaging in a short-bore closed MRI scanner.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Charité

Principal Investigators

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Marc Dewey, MD

Role: PRINCIPAL_INVESTIGATOR

Charité

Locations

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Charité

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 17969166 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17383136 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21310075 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24391767 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21887259 (View on PubMed)

Other Identifiers

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EA1/020/08

Identifier Type: -

Identifier Source: org_study_id

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