An observational study in Anxiety, Claustrophobia and Hyperventilation, sponsored by Military Institute of Aviation Medicine. Completed at 1 site in Poland. Per ClinicalTrials.gov, last updated 2026-03-09.
Sponsored by Military Institute of Aviation Medicine · Observational
This study is to determine the possibility of assessing the level of anxiety in MRI patients by means of the respiration rate (RR) and heart rate (HR) indicators acquired by a fiber-optic sensor system. The mean RR and/or HR values recorded at the beginning and the end of an MRI scanning will be referred to the State Trait Anxiety Inventory (STAI) scores completed before and after the MRI scanning, respectively.
The main purpose of the study is to determine the possibility of assessing the level of anxiety by means of the respiration curve and/or ballistocardiographic (BCG) signal acquired from MRI patients using a fiber-optic sensor system. In many patients, the MRI examination causes enormous stress due to limited space in the scanner, isolation during the examination and high noise levels. Usually, anxiety or stress triggers an increase in respiration rate (RR), leading to hyperventilation in extreme cases. There are also frequent cases of disturbances in heart rate (HR). Thus, the symptoms of claustrophobia can be detected by monitoring respiration activity and heart work.
The fiber-optic sensor system consists of a sensor mat, an interrogator and a personal computer (PC), and records respiratory and BCG signals in patients during MRI. The metal-free sensor mat is placed under the patient's back, does not pose a threat to the patient and has no influence over the quality of imaging. The interrogation module detects the optical signal including vital signs, and the PC with software developed for signal processing and visualization enable the MRI operator to monitor patient's RR and HR.
Up to 200 MRI patients in different age, weight, and gender will be participated in the study. They will be asked to complete the State Trait Anxiety Inventory (STAI) questionnaire in order to estimate anxiety level before and after the MRI scanning. Relations between the STAI X-1 scores and the mean RR and/or HR values recorded at the beginning and the end of the MRI scanning will be analyzed using descriptive statistic methods. The research scheme includes also the collection of the STAI X-2 scores before the MRI scanning. Finally, the values of the physiological parameters, which may indicate a dangerous level of anxiety will be determined. Positive results of the clinical evaluation will predestine the fiber-optic sensor system to be implemented in routine MRI procedures.
43 studies on the registry are indexed under Hyperventilation; 6 are open to participants now.
This study's planned enrollment of 200 is above the median of 54 across 11 observational studies indexed under Hyperventilation.
Browse Hyperventilation studies →Military Institute of Aviation Medicine is the lead sponsor of 3 studies on the registry; none are open to participants now.
Compared within Hyperventilation, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Up to 200 MRI patients of different age, weight and sex.
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.
Exclusion Criteria:
Up to 200 patients of different age, weight and sex, which undergo MRI examinations.
Diagnostic Test: MRI examination
The part of the body that is being scanned and the time of the MRI examination are not relevant.
Optical signal
Instantaneous spectral position of the fiber Bragg grating (FBG) reflection peak in nanometers that represents respiration curve and ballistocardiogram
Time frame: 60 minutes
RR
Respiration rate in respirations per minute
Time frame: 60 minutes
HR
Heart rate in beats per minute
Time frame: 60 minutes
RR_1
Respiration rate at the beginning of the MRI scanning in respirations per minute
Time frame: 2 minutes
RR_2
Respiration rate at the end of the MRI scanning in respirations per minute
Time frame: 2 minutes
HR_1
Heart rate at the beginning of the MRI scanning in beats per minute
Time frame: 2 minutes
HR_2
Heart rate at the end of the MRI scanning in beats per minute
Time frame: 2 minutes
STAI X-1_1
STAI X-1 scores completed before the MRI scanning. Scale range: 20 - 80 (raw scores), where 20 means low anxiety, and 80 indicates high anxiety (the higher the result, the higher the level of anxiety).
Time frame: 1 minute
STAI X-1_2
STAI X-1 scores completed after the MRI scanning. Scale range: 20 - 80 (raw scores), where 20 means low anxiety, and 80 indicates high anxiety (the higher the result, the higher the level of anxiety).
Time frame: 1 minute
STAI X-2
STAI X-2 scores completed before the MRI scanning. Scale range: 20 - 80 (raw scores), where 20 means low anxiety, and 80 indicates high anxiety (the higher the result, the higher the level of anxiety).
Time frame: 1 minute
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Military Institute of Aviation Medicine