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Effect of IE Glasses on MRI Patient Outcomes

ConditionsMRI-related AnxietyMRI Completion Rate
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBaptist Health South Florida

About this trial

Examine the effect of immersive entertainment glasses (IEG) on patients' claustrophobia-associated anxiety levels during magnetic resonance imaging (MRI).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients at least 18 years of age

Outpatients/inpatients scheduled for an MRI with anesthesia

Inpatients scheduled for an MRI with an IV/PO sedative

Disqualifiers

Pregnant patients

Trial design

Design model

Parallel

Treatments tested in this trial

  • Immersive entertainment glasses

    Device

    Use of immersive entertainment glasses during the MRI procedure.

  • Standard of Care: Anesthesia

    Drug

    Patient receives anesthesia as ordered by the physician.

  • Standard of Care: Sedative

    Drug

    Patient receives a sedative as ordered by the physician.

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: Control Group 1Active comparator 1 intervention
Group B: Control Group 2Active comparator 1 intervention
Group C: Intervention GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Anxiety relief (self-report measure 2 - Visual Analog Scale for Anxiety)

Patient's anxiety will be measured using the Visual Analog Scale for Anxiety (VAS-A), a slider scale of 0 - 100 is used to self-report anxiety (0 = not anxious and 100 = extremely anxious), taken before and after the MRI procedure.

Time frame
15 to 120 minutes (depends on the duration of the MRI procedure)
2

Anxiety relief (physiological measure - heart rate)

Heart rate is measured before and after the MRI procedure. Increased anxiety may cause elevation of this physiological indicator.

Time frame
15 to 120 minutes (depends on the duration of the MRI procedure)
3

MRI completion rate

MRI completed successfully = yes or no

Time frame
Immediately after the MRI procedure.
4

MRI Image Quality

Quality of the images as noted by the radiologist on the MRI report.

Time frame
Immediately after the MRI procedure.

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Baptist Health South Florida

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: