Clinical trial NCT00715806: Claustrophobia and Magnetic Resonance Imaging
Official title: Reduction of Claustrophobia During Magnetic Resonance Imaging: Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Claustrophobia
Keywords: claustrophobia
magnetic resonance imaging
MRI
anxiety
open design
severely anxious patients
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2008-07-15
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: The ability of an open MRI scanner to reduce claustrophobic reactions that prevent MR examinations.
timeFrame: Before or During MRI
Secondary outcomes:
measure: Impact of MR imaging results on subsequent measurement.
timeFrame: 6 months after MRI
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité
Study officials:
affiliation: Charité
name: Marc Dewey, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.