Efficacy of Immersive Entertainement Glasses in Magnetic Resonance Imaging (MRI)
NCT05304143 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 206
Last updated 2022-11-25
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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