MRI-related AnxietyNCT07660952
Effect of IE Glasses on MRI Patient Outcomes
A study testing Immersive entertainment glasses in people with MRI-related Anxiety and MRI Completion Rate, run by Baptist Health South Florida.
Trial summary
Examine the effect of immersive entertainment glasses (IEG) on patients' claustrophobia-associated anxiety levels during magnetic resonance imaging (MRI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MRI-related Anxiety, MRI Completion Rate
- What is being tested?
- Immersive entertainment glasses
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant patients
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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).
- Conditions
- MRI-related Anxiety, MRI Completion Rate
- Being tested
- Immersive entertainment glasses, Standard of Care: Anesthesia, Standard of Care: Sedative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive entertainment glassesDevice
Use of immersive entertainment glasses during the MRI procedure.
Standard of Care: AnesthesiaDrug
Patient receives anesthesia as ordered by the physician.
Standard of Care: SedativeDrug
Patient receives a sedative as ordered by the physician.
| Study group | Role | What they receive |
|---|---|---|
| Control Group 1 | Active comparator | Patients who receive anesthesia (general or conscious sedation) for completion of their MRI scans as ordered by the physician. Receives: Drug: Standard of Care: Anesthesia |
| Control Group 2 | Active comparator | 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. Receives: Drug: Standard of Care: Sedative |
| Intervention Group | Experimental | 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. Receives: Device: Immersive entertainment glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 to 120 minutes (depends on the duration of the MRI procedure)
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.
Measured: 15 to 120 minutes (depends on the duration of the MRI procedure)
MRI completion rate
MRI completed successfully = yes or no
Measured: Immediately after the MRI procedure.
MRI Image Quality
Quality of the images as noted by the radiologist on the MRI report.
Measured: Immediately after the MRI procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MRI-related AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baptist Health South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natalie Bermudez, PhD, RN, EBP-C, Study chair, Baptist Health | Nursing & Health Sciences Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07660952
- Sponsor's protocol ID
- 2355080
- Status last verified
- Sep 2026
- First submitted
- 16 Jun 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effect of Immersive Entertainment Glasses on Magnetic Resonance Imaging-related Patient Outcomes
- ClinicalTrials.gov ID
- NCT07660952
- Acronym / sponsor ID
- 2355080
- Conditions
- MRI-related Anxiety, MRI Completion Rate
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Baptist Health South FloridaUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Examine the effect of immersive entertainment glasses (IEG) on patients' claustrophobia-associated anxiety levels during magnetic resonance imaging (MRI).
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group 1 | Active comparator | Drug: Standard of Care: AnesthesiaPatients who receive anesthesia (general or conscious sedation) for completion of their MRI scans as ordered by the physician. |
| Control Group 2 | Active comparator | Drug: Standard of Care: SedativePatients 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. |
| Intervention Group | Experimental | Device: Immersive entertainment glassesPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Pregnant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immersive entertainment glassesUse of immersive entertainment glasses during the MRI procedure. | Device | Intervention Group |
| Standard of Care: AnesthesiaPatient receives anesthesia as ordered by the physician. | Drug | Control Group 1 |
| Standard of Care: SedativePatient receives a sedative as ordered by the physician. | Drug | Control Group 2 |
Primary outcome
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.
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.
MRI completion rate
Time frame: Immediately after the MRI procedure.
MRI completed successfully = yes or no
MRI Image Quality
Time frame: Immediately after the MRI procedure.
Quality of the images as noted by the radiologist on the MRI report.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Natalie Bermudez, PhD, RN, EBP-C study chair
Baptist Health | Nursing & Health Sciences Research
Questions about this trial
What is this clinical trial studying?
A study testing Immersive entertainment glasses in people with MRI-related Anxiety and MRI Completion Rate, run by Baptist Health South Florida.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frank Boza, BSN, RN, VA-BC (786-662-0660, frankbo@baptisthealth.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.