Anxiety Clinical Trial
— OPTO-MRIOfficial title:
Clinical Evaluation of a Fiber-optic Sensor System for Monitoring Respiration Activity and Heart Work During MRI Examinations
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | September 30, 2018 |
Est. primary completion date | September 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - MRI patients Exclusion Criteria: - Same as in MRI procedures |
Country | Name | City | State |
---|---|---|---|
Poland | Military Institute of Aviation Medicine | Warszawa |
Lead Sponsor | Collaborator |
---|---|
Military Institute of Aviation Medicine |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | RR_1 | Respiration rate at the beginning of the MRI scanning in respirations per minute | 2 minutes | |
Other | RR_2 | Respiration rate at the end of the MRI scanning in respirations per minute | 2 minutes | |
Other | HR_1 | Heart rate at the beginning of the MRI scanning in beats per minute | 2 minutes | |
Other | HR_2 | Heart rate at the end of the MRI scanning in beats per minute | 2 minutes | |
Other | 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). | 1 minute | |
Other | 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). | 1 minute | |
Other | 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). | 1 minute | |
Primary | Optical signal | Instantaneous spectral position of the fiber Bragg grating (FBG) reflection peak in nanometers that represents respiration curve and ballistocardiogram | 60 minutes | |
Secondary | RR | Respiration rate in respirations per minute | 60 minutes | |
Secondary | HR | Heart rate in beats per minute | 60 minutes |
Status | Clinical Trial | Phase | |
---|---|---|---|
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