- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07660952
Effect of IE Glasses on MRI Patient Outcomes
June 16, 2026 updated by: Baptist Health South Florida
Examining the Effect of Immersive Entertainment Glasses on Magnetic Resonance Imaging-related Patient Outcomes
Examine the effect of immersive entertainment glasses (IEG) on patients' claustrophobia-associated anxiety levels during magnetic resonance imaging (MRI).
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Frank Boza, BSN, RN, VA-BC
- Phone Number: 786-662-0660
- Email: frankbo@baptisthealth.net
Study Contact Backup
- Name: Marian Ramos, MSN, RN, CBN
- Phone Number: 786-527-6208
- Email: marianr@baptisthealth.net
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Pregnant patients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group 1
Patients who receive anesthesia (general or conscious sedation) for completion of their MRI scans as ordered by the physician.
|
Patient receives anesthesia as ordered by the physician.
|
|
Active Comparator: Control Group 2
Patients who receive oral or intravenous sedation [i.e., benzodiazepines such as lorazepam (Ativan), diazepam (Valium), alprazolam (Xanax), or equivalent] for completion of their MRI scans, as ordered by the physician.
|
Patient receives a sedative as ordered by the physician.
|
|
Experimental: Intervention Group
Patients scheduled for MRIs with anesthesia or a sedative choose to use the immersive entertainment glasses (instead of the physician-ordered anesthesia or sedative) for completion of their MRI scans.
|
Use of immersive entertainment glasses during the MRI procedure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety relief (self-report measure 2 - Visual Analog Scale for Anxiety)
Time Frame: 15 to 120 minutes (depends on the duration of the MRI procedure)
|
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.
|
15 to 120 minutes (depends on the duration of the MRI procedure)
|
|
Anxiety relief (physiological measure - heart rate)
Time Frame: 15 to 120 minutes (depends on the duration of the MRI procedure)
|
Heart rate is measured before and after the MRI procedure.
Increased anxiety may cause elevation of this physiological indicator.
|
15 to 120 minutes (depends on the duration of the MRI procedure)
|
|
MRI completion rate
Time Frame: Immediately after the MRI procedure.
|
MRI completed successfully = yes or no
|
Immediately after the MRI procedure.
|
|
MRI Image Quality
Time Frame: Immediately after the MRI procedure.
|
Quality of the images as noted by the radiologist on the MRI report.
|
Immediately after the MRI procedure.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Natalie Bermudez, PhD, RN, EBP-C, Baptist Health | Nursing & Health Sciences Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2027
Study Registration Dates
First Submitted
June 16, 2026
First Submitted That Met QC Criteria
June 16, 2026
First Posted (Actual)
June 22, 2026
Study Record Updates
Last Update Posted (Actual)
June 22, 2026
Last Update Submitted That Met QC Criteria
June 16, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 2355080
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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