CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 206 enrolled
Drug / intervention
Virtual Immersive Reality Glasses +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05304143
NCT05304143N/ACompleted

Efficacy of Immersive Entertainement Glasses in Magnetic Resonance Imaging to Reduce Claustrofobia: Clinical Control Trial

Hospital Mutua de Terrassa·interventional·Posted Mar 31, 2022·Updated Nov 25, 2022

In Brief

A clinical study evaluating Virtual Immersive Reality Glasses and Conventional nurse support for Claustrophobia and Magnetic Resonance Imaging (MRI). Completed, enrolled 206 participants across 1 site.

Detailed Summary

Background: Claustrophobia is the most common type of specific phobia, and in the context of performing an MRI, it leads to premature completion of the test or a sedation. According to some authors, 1,6% of the patients terminated the test prematurely due to claustrophobia, and, in addition, 3.8% underwent conscious sedation. These procedures increase the risk of complications, and the cost of care. The use of anxiolytics is an option to reduce anxiety, but these drugs carry the possibility of suffering adverse effects, and the fact that patients cannot drive home when the MRI is finished. For these reasons, it is especially relevant to determine which non-pharmacological interventions are most effective, and among them, the use of Immersive Entertainment Glasses is a low-interventionist option that can help to overcome fear of the test. Objective: To determine the effectiveness of Immersive Entertainment Glasses in the success of the performance of an MRI and in the reduction of anxiety levels, in patients who express having claustrophobia. Methodology: Design: Clinical trial with intervention and control group. Participants: patients who define themselves as claustrophobic and should have an MRI. The sample will be made up of 206 individuals, divided between an intervention group and a control group. expecting a 20% difference between the success of the test of the control and intervention group subjects. People who meet the inclusion criteria will be distributed into the control or intervention group. The intervention group will use the Immersive Entertainment Glasses to perform the MRI and the control group will have the support of the nurse through educational techniques. Expected results: the success rate in performing MRIs is expected to increase by 20%, thanks to the use of Immersive Entertainment Glasses. Expected duration: 12 months, or until obtaining the expected sample.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain
CollaboratorsGeneral Electric

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMar 31, 2022
Enrollment StartJan 1, 2022
Primary CompletionNov 3, 2022
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 4.3 years ago

Interventions

Virtual Immersive Reality Glassesother

The day of the examination, the patient will go to the MRI room and he will be fitted with virtual reality glasses compatible with the MRI equipment. The patient will visualize relaxing contents in open spaces with music and verbal instructions during all the procedure. The contents will be previously validated by the clinical psychologist of the center with experience in this regard. During the test, the patient's heart rate will be monitored.

Conventional nurse supportother

Patients will be treated using the usual support technique to reduce anxiety in the Diagnostic Imaging service