Prediction of Claustrophobia During MR Imaging (CLAUSTRO II)

August 2, 2021 updated by: Marc Dewey, Charite University, Berlin, Germany

Prediction of Claustrophobia During MR Imaging: An Observational 18-Months Single Center Study

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

8000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charité

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Up to 5 min after the end of the MR

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Up to 5 min after the end of the MR
Identification of influential factors for the prediction of a claustrophobic event
Time Frame: Up to 5 min after the end of the MR
Up to 5 min after the end of the MR

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Marc Dewey, PD Dr. med., Charité

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

May 31, 2011

First Submitted That Met QC Criteria

June 3, 2011

First Posted (Estimate)

June 6, 2011

Study Record Updates

Last Update Posted (Actual)

August 6, 2021

Last Update Submitted That Met QC Criteria

August 2, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA1/020/08/E

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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