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Claustrophobia and Magnetic Resonance Imaging (CLAUSTRO)

Primary Purpose

Claustrophobia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Open MRI scanner.
Closed MRI scanner.
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Claustrophobia focused on measuring claustrophobia, magnetic resonance imaging, MRI, anxiety, open design, severely anxious patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charité

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

The ability of an open MRI scanner to reduce claustrophobic reactions that prevent MR examinations.

Secondary Outcome Measures

Impact of MR imaging results on subsequent measurement.

Full Information

First Posted
July 10, 2008
Last Updated
June 21, 2011
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT00715806
Brief Title
Claustrophobia and Magnetic Resonance Imaging
Acronym
CLAUSTRO
Official Title
Reduction of Claustrophobia During Magnetic Resonance Imaging: Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Claustrophobia
Keywords
claustrophobia, magnetic resonance imaging, MRI, anxiety, open design, severely anxious patients

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
174 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Open MRI scanner.
Intervention Description
Imaging in an Open MRI scanner.
Intervention Type
Device
Intervention Name(s)
Closed MRI scanner.
Intervention Description
Imaging in a short-bore closed MRI scanner.
Primary Outcome Measure Information:
Title
The ability of an open MRI scanner to reduce claustrophobic reactions that prevent MR examinations.
Time Frame
Before or During MRI
Secondary Outcome Measure Information:
Title
Impact of MR imaging results on subsequent measurement.
Time Frame
6 months after MRI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Dewey, MD
Organizational Affiliation
Charité
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
17969166
Citation
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.
Results Reference
background
PubMed Identifier
17383136
Citation
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.
Results Reference
background
PubMed Identifier
21310075
Citation
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.
Results Reference
background
PubMed Identifier
24391767
Citation
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.
Results Reference
derived
PubMed Identifier
21887259
Citation
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.
Results Reference
derived

Learn more about this trial

Claustrophobia and Magnetic Resonance Imaging

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