NCT01367067

Brief Summary

The objective of the study is to search for possible predictors for claustrophobia during magnetic resonance (MR) imaging. A claustrophobic event shall be defined by an incomplete examination, or a complete examination that requires coping actions by the staff. Coping actions may consist of the administration of sedatives, prism glasses, an MR imaging test run with the patient, a pause, the prone position, an escort in the scanner room, and supportive communication. The investigators hypothesize that there is a difference between patients with and without events in their scores on the Claustrophobia Questionnaire and several further psychometric questions. Other factors may also favour events like patient characteristics, examined region, duration of the examination and scanner type. Therefore, predictors could identify patients who are likely to experience claustrophobia during MR imaging so that they can receive the appropriate support by the staff to complete their examination. Thus a larger patient population could benefit from MR imaging.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2011

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2011

Completed
Last Updated

August 6, 2021

Status Verified

August 1, 2021

Enrollment Period

1.4 years

First QC Date

May 31, 2011

Last Update Submit

August 2, 2021

Conditions

Keywords

claustrophobiamagnetic resonance imagingMRIanxietyanxious patientsphobic disordersanxiety disordersmental disorders

Outcome Measures

Primary Outcomes (1)

  • The mean score of the Claustrophobia Questionnaire for the prediction of a claustrophobic event during MR imaging

    Up to 5 min after the end of the MR

Secondary Outcomes (2)

  • Identification of specific psychometric questions for the prediction of a claustrophobic event during MR imaging

    Up to 5 min after the end of the MR

  • Identification of influential factors for the prediction of a claustrophobic event

    Up to 5 min after the end of the MR

Study Arms (2)

Psychometric Questionnaire

Adult inpatients and outpatients with a clinical indication of any part of the body who have been referred to Charité for MR imaging and have filled out a psychometric questionnaire

No Psychometric Questionnaire

Adult inpatients and outpatients with a clinical indication of any part of the body who have been referred to Charité for MR imaging and did not fill out a psychometric questionnaire

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult inpatients and outpatients with a clinical indication of any part of the body who are referred to Charité for MR imaging

You may qualify if:

  • Inpatients and outpatients referred to MR imaging with a clinical indication of any part of the body
  • Mentally and physically able to fill out a questionnaire
  • Sufficient German language skills

You may not qualify if:

  • Age under 18 years
  • Patients from the Intensive Care Unit
  • Severe emergencies
  • Surgery during MR imaging
  • Participation in other studies
  • Fetal and prenatal examinations
  • Referral from medical jurisprudence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité

Berlin, 10117, Germany

Location

Related Publications (4)

  • 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.

    PMID: 17969166BACKGROUND
  • 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.

    PMID: 17383136BACKGROUND
  • 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.

    PMID: 21310075BACKGROUND
  • Napp AE, Enders J, Roehle R, Diederichs G, Rief M, Zimmermann E, Martus P, Dewey M. Analysis and Prediction of Claustrophobia during MR Imaging with the Claustrophobia Questionnaire: An Observational Prospective 18-month Single-Center Study of 6500 Patients. Radiology. 2017 Apr;283(1):148-157. doi: 10.1148/radiol.2016160476. Epub 2016 Nov 25.

Related Links

MeSH Terms

Conditions

ClaustrophobiaAnxiety DisordersPhobic DisordersMental Disorders

Study Officials

  • Marc Dewey, PD Dr. med.

    Charité

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Radiology

Study Record Dates

First Submitted

May 31, 2011

First Posted

June 6, 2011

Study Start

January 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

August 6, 2021

Record last verified: 2021-08

Locations