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

NCT05304143 | Completed DMC

• 1 other identifier: P/21-095
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Immersive Entertainment Reality; Claustrophobia; Magnetic Resonance Imaging (MRI)

Outcome Measures

Primary Outcomes (2)

• Succes in the performance of an MRI

  Number of patients that will finish the MRI

  One hour

• Anxiety reduction

  Decrease of the levels of anxiety measured with the State Trait Anxiety Inventory (STAI)

  One hour

Secondary Outcomes (3)

• Image quality

  Half an hour

• Failed MRI

  One hour

• Patient satisfaction

  One hour

Study Arms (2)

Virtual Reality intervention group

EXPERIMENTAL

The exploration in the intervention group will be carried out with virtual reality glasses compatible with the magnetic resonance imaging equipment.

Other: Virtual Immersive Reality Glasses

Conventional nurse support

ACTIVE COMPARATOR

The exploration in the control group will be carried out with the standard procedure for claustrophobic patients that includes close nursing support.

Other: Conventional nurse support

Interventions

Virtual Immersive Reality Glasses OTHER

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.

Virtual Reality intervention group

Conventional nurse support OTHER

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

Conventional nurse support

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with self-reported fear of enclosed spaces
• Patients with fear of having an MRI

You may not qualify if:

• Patients who must undergo a sustained breathing exploration during the test
• Patients who have a contraindicated MRI
• Pregnant women

Sponsors & Collaborators

• Hospital Mutua de Terrassa: lead
• General Electric: collaborator

Study Sites (1)

Mútua de Terrassa

Terrassa, Barcelona, 08221, Spain

Location

Related Publications (10)

• Carpenter JK, Moskow DM, Hofmann SG. Enhanced Mental Reinstatement of Exposure to Improve Extinction Generalization: A Study on Claustrophobia and MRI Fear. Behav Ther. 2023 Jan;54(1):156-169. doi: 10.1016/j.beth.2022.08.002. Epub 2022 Aug 13.

  PMID: 36608973 BACKGROUND

• Brown RKJ, Petty S, O'Malley S, Stojanovska J, Davenport MS, Kazerooni EA, Fessahazion D. Virtual Reality Tool Simulates MRI Experience. Tomography. 2018 Sep;4(3):95-98. doi: 10.18383/j.tom.2018.00023.

  PMID: 30320208 BACKGROUND

• Pull CB. Recent trends in the study of specific phobias. Curr Opin Psychiatry. 2008 Jan;21(1):43-50. doi: 10.1097/YCO.0b013e3282f30086.

  PMID: 18281840 BACKGROUND

• Rahani VK, Vard A, Najafi M. Claustrophobia Game: Design and Development of a New Virtual Reality Game for Treatment of Claustrophobia. J Med Signals Sens. 2018 Oct-Dec;8(4):231-237. doi: 10.4103/jmss.JMSS_27_18.

  PMID: 30603615 BACKGROUND

• Tugwell JR, Goulden N, Mullins P. Alleviating anxiety in patients prior to MRI: A pilot single-centre single-blinded randomised controlled trial to compare video demonstration or telephone conversation with a radiographer versus routine intervention. Radiography (Lond). 2018 May;24(2):122-129. doi: 10.1016/j.radi.2017.10.001. Epub 2017 Oct 31.

  PMID: 29605108 BACKGROUND

• Garcia-Palacios A, Hoffman HG, Richards TR, Seibel EJ, Sharar SR. Use of virtual reality distraction to reduce claustrophobia symptoms during a mock magnetic resonance imaging brain scan: a case report. Cyberpsychol Behav. 2007 Jun;10(3):485-8. doi: 10.1089/cpb.2006.9926.

  PMID: 17594277 BACKGROUND

• King S, Woodley J, Walsh N. A systematic review of non-pharmacologic interventions to reduce anxiety in adults in advance of diagnostic imaging procedures. Radiography (Lond). 2021 May;27(2):688-697. doi: 10.1016/j.radi.2020.09.018. Epub 2020 Oct 4.

  PMID: 33028496 BACKGROUND

• Spielberger CD Lushene PR, Jacobs GA. GRL. Manual for the State-Trait Anxiety Inventory. Consult Psychol Press. 1983.

  BACKGROUND

• Vadakkan C, Siddiqui W. Claustrophobia. 2023 Feb 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK542327/

  PMID: 31194467 BACKGROUND

• Diaz-Membrives M, Garrido-Ribas I, Caro-Benito C, Font-Cabrera C, Monistrol O. Claustrophobia in magnetic resonance imaging: A randomised controlled trial of immersive entertainment glasses. Radiography (Lond). 2026 Jan 3;32(2):103318. doi: 10.1016/j.radi.2025.103318. Online ahead of print.

  PMID: 41485316 DERIVED

MeSH Terms

Conditions

Claustrophobia

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Montserrat Díaz Membrives, PhD

  Supervisor of Imaging Diagnostics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: March 31, 2022
• Study Start: January 1, 2022
• Primary Completion: November 3, 2022
• Study Completion: November 3, 2022
• Last Updated: November 25, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)