NCT05304143: Claustro-VIR

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

Completed NA Last updated 25 November 2022

What this trial tests

NA trial testing Virtual Immersive Reality Glasses in Claustrophobia in 206 participants. Completed in 3 November 2022.

Timeline

1 January 2022

Primary endpoint
3 November 2022

3 November 2022

Quick facts

Lead sponsor	Hospital Mutua de Terrassa
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	206
Start date	1 January 2022
Primary completion	3 November 2022
Estimated completion	3 November 2022
Sites	1 location across Spain

Drugs / interventions tested

• Virtual Immersive Reality Glasses
• Conventional nurse support

Conditions studied

• Claustrophobia — all drugs for Claustrophobia →
• Magnetic Resonance Imaging (MRI) — all drugs for Magnetic Resonance Imaging (MRI) →

Sponsor

Hospital Mutua de Terrassa

Who can join

Adults 18 to 90, any sex, with Claustrophobia or Magnetic Resonance Imaging (MRI). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Claustrophobia in magnetic resonance imaging: A randomised controlled trial of immersive entertainment glasses.
   Diaz-Membrives M, Garrido-Ribas I, Caro-Benito C, Font-Cabrera C, et al · · 2026 · PMID 41485316 · DOI 10.1016/j.radi.2025.103318