NCT03384849

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 27, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

2.6 years

First QC Date

December 20, 2017

Last Update Submit

March 6, 2026

Conditions

AnxietyClaustrophobiaHyperventilationStress

Keywords

Fiber-optic sensor systemMagnetic resonance imagingMedical monitoringPhysiological parameters

Outcome Measures

Primary Outcomes (1)

  • Optical signal

    Instantaneous spectral position of the fiber Bragg grating (FBG) reflection peak in nanometers that represents respiration curve and ballistocardiogram

    60 minutes

Secondary Outcomes (2)

  • RR

    60 minutes

  • HR

    60 minutes

Other Outcomes (7)

  • RR_1

    2 minutes

  • RR_2

    2 minutes

  • HR_1

    2 minutes

  • +4 more other outcomes

Study Arms (1)

MRI patients

Up to 200 patients of different age, weight and sex, which undergo MRI examinations.

Diagnostic Test: MRI examination

Interventions

MRI examinationDIAGNOSTIC_TEST

The part of the body that is being scanned and the time of the MRI examination are not relevant.

MRI patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Up to 200 MRI patients of different age, weight and sex.

You may qualify if:

  • MRI patients

You may not qualify if:

  • Same as in MRI procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Military Institute of Aviation Medicine

Warsaw, 01-755, Poland

Location

MeSH Terms

Conditions

Anxiety DisordersClaustrophobiaHyperventilation

Condition Hierarchy (Ancestors)

Mental DisordersPhobic DisordersRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Łukasz Dziuda, DSc, PhD

    Military Institute of Aviation Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2017

First Posted

December 27, 2017

Study Start

January 3, 2017

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

March 9, 2026

Record last verified: 2026-03

Locations

PL(1)