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Prediction of Claustrophobia During MR Imaging (CLAUSTRO II)

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ClinicalTrials.gov Identifier: NCT01367067
Recruitment Status : Completed
First Posted : June 6, 2011
Last Update Posted : July 4, 2011
Sponsor:
Information provided by:

Study Description
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.

Condition or disease
Claustrophobia

Study Design

Study Type : Observational
Actual Enrollment : 8000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prediction of Claustrophobia During MR Imaging: An Observational 18-Months Single Center Study
Study Start Date : January 2010
Primary Completion Date : June 2011
Study Completion Date : June 2011

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U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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
Criteria

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:

  • 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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01367067


Locations
Germany
Charité
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Marc Dewey, PD Dr. med. Charité