ClaustrophobiaCLAUSTRO IINCT01367067
Prediction of Claustrophobia During MR Imaging
An observational study of Claustrophobia, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Claustrophobia
- How many people
- 8,000 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2010to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult inpatients and outpatients with a clinical indication of any part of the body who are referred to Charité for MR imaging
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Claustrophobia
- Keywords
- claustrophobia, magnetic resonance imaging, MRI, anxiety, anxious patients, phobic disorders, anxiety disorders, mental disorders
- Medical subject headings
- Claustrophobia, Anxiety Disorders, Phobic Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
The mean score of the Claustrophobia Questionnaire for the prediction of a claustrophobic event during MR imaging
Measured: 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
Measured: Up to 5 min after the end of the MR
Identification of influential factors for the prediction of a claustrophobic event
Measured: Up to 5 min after the end of the MR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2011 (estimated)
- Study startJan 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ClaustrophobiaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Dewey, Charite University, Berlin, Germany
- Investigators
- Marc Dewey, PD Dr. med., Principal investigator, Charité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01367067
- Sponsor's protocol ID
- EA1/020/08/E
- Acronym
- CLAUSTRO II
- Status last verified
- Aug 2021
- First submitted
- 31 May 2011
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
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 17969166Dewey 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 17383136Enders 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 21310075Napp 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Claustrophobia During MR Imaging: An Observational 18-Months Single Center Study
- ClinicalTrials.gov ID
- NCT01367067
- Acronym / sponsor ID
- CLAUSTRO II / EA1/020/08/E
- Conditions
- Claustrophobia
- Keywords
- claustrophobia, magnetic resonance imaging, MRI, anxiety, anxious patients, phobic disorders, anxiety disorders, mental disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,000 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 6 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult inpatients and outpatients with a clinical indication of any part of the body who are referred to Charité for MR imaging
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- Age under 18 years
- Patients from the Intensive Care Unit
- Severe emergencies
- Surgery during MR imaging
- Participation in other studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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
Identification of influential factors for the prediction of a claustrophobic event
Time frame: Up to 5 min after the end of the MR
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Background: PubMed 17969166Dewey 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.
- Background: PubMed 17383136Dewey 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.
- Background: PubMed 21310075Enders 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.
- Results publication: PubMed 27892781Napp 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.
- Radiology at CharitéLink provided by the sponsor.
Related trials for Claustrophobia
Not yet recruiting
Comparing Radiotherapy Immobilization Systems for Anxious HNC Patients
Head and Neck Cancer, Claustrophobia
Not yet recruitingPhase 2/3
Evaluation of the Effectiveness of a Cardiac Coherence Exercise on MRI Success and Image Quality in Claustrophobic Patients
Claustrophobia, MRI
Recruiting
Internet-Based Cognitive Behavioral Therapy for MRI-Related Anxiety
Anxiety, Claustrophobia
RecruitingObservational study
Premedication for Claustrophobic Patients for MRI Scan
Claustrophobia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Dewey, PD Dr. med. principal investigator
Charité
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Claustrophobia, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01367067, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2021.