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CompletedNCT01367067CLAUSTRO IIUpdated Aug 6, 2021

Prediction of Claustrophobia During MR Imaging

An observational study in Claustrophobia, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-06.

Primary conditionAnxiety Disorders(the registry's first term)UnverifiedIs this wrong?The registry often attaches Anxiety Disorders to studies about something else, and this study's title and listed conditions do not name it. No better condition is named, so the registry's term is kept.

Sponsored by Charite University, Berlin, Germany · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
8,000
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Claustrophobia

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Keywords

  • claustrophobia
  • magnetic resonance imaging
  • MRI
  • anxiety
  • anxious patients
  • phobic disorders
  • anxiety disorders
  • mental disorders
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In context

Anxiety Disorders Unverified

7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.

This study's enrollment of 8,000 is above the median of 168 across 977 observational studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 857 studies on the registry; 129 are open to participants now.

Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability 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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
8,000 participants (actual)

Groups and cohorts

  • 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

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What researchers measure

Primary outcomes

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

    Time frame: Up to 5 min after the end of the MR

Secondary outcomes

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

    Time frame: Up to 5 min after the end of the MR

  2. Identification of influential factors for the prediction of a claustrophobic event

    Time frame: Up to 5 min after the end of the MR

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Study locations

1 site
  • Charité
    Berlin, 10117, Germany
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References and documents

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. PubMed 17969166 ↗
  • 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. PubMed 17383136 ↗
  • 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. PubMed 21310075 ↗
  • 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. PubMed 27892781 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2010, a primary completion of Jun 2011 and a completion of Jun 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 31, 2011
First posted
Jun 6, 2011
Start
Jan 2010
Primary completionActual
Jun 2011
CompletionActual
Jun 2011
Last update
Aug 6, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01367067
Responsible party
Marc Dewey (Professor of Radiology, Charite University, Berlin, Germany) — Principal investigator
First posted
Jun 6, 2011
Start date
Jan 2010
Primary completion
Jun 2011
Completion
Jun 2011
Last update
Aug 6, 2021

Study contacts

Marc Dewey, PD Dr. med.
principal investigator · Charité

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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