Prediction of Claustrophobia During MR Imaging (CLAUSTRO II)

This study has been completed.
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01367067
First received: May 31, 2011
Last updated: July 1, 2011
Last verified: May 2011
  Purpose

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
Claustrophobia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prediction of Claustrophobia During MR Imaging: An Observational 18-Months Single Center Study

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Identification of influential factors for the prediction of a claustrophobic event [ Time Frame: Up to 5 min after the end of the MR ] [ Designated as safety issue: No ]

Enrollment: 8000
Study Start Date: January 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01367067

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

Publications:
Responsible Party: Marc Dewey, Charité
ClinicalTrials.gov Identifier: NCT01367067     History of Changes
Other Study ID Numbers: EA1/020/08/E
Study First Received: May 31, 2011
Last Updated: July 1, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
claustrophobia
magnetic resonance imaging
MRI
anxiety
anxious patients
phobic disorders
anxiety disorders
mental disorders

Additional relevant MeSH terms:
Phobic Disorders
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2014