Efficacy of Immersive Entertainement Glasses in Magnetic Resonance Imaging (MRI)

NCT05304143 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2022-11-25

No results posted yet for this study

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.

Conditions

  • Claustrophobia
  • Magnetic Resonance Imaging (MRI)

Interventions

OTHER

Virtual Immersive Reality Glasses

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.

OTHER

Conventional nurse support

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

Sponsors & Collaborators

  • General Electric

    collaborator INDUSTRY
  • Hospital Mutua de Terrassa

    lead OTHER

Principal Investigators

  • Montserrat Díaz Membrives, PhD · Supervisor of Imaging Diagnostics

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2022-11-03
Completion
2022-11-03

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05304143 on ClinicalTrials.gov