Efficacy of Immersive Entertainement Glasses in Magnetic Resonance Imaging (MRI)
Condition: Claustrophobia; Magnetic Resonance Imaging (MRI)
MeSH terms: Phobic Disorders
Study type: Interventional

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.
    

Detailed description: 
      INTRODUCTION According to the Diagnostic and Statistical Manual of Mental Disorders (DSM V),
      there are many categories of anxiety disorders. The specific phobias are a type of disorder
      where there is an extreme fear of people, objects, or specific situations. Among the most
      common symptoms are physical and emotional ones. Physical symptoms may include, but are not
      limited to, shortness of breath, trembling, sweating, tachycardia, dry mouth, and chest pain.
      The most frequent emotional symptoms are feeling overwhelmed by anxiety or fear, presenting
      fear of losing control, needing to leave the place that causes anxiety and understanding that
      it is an irrational fear but not being able to avoid it. According to some authors, the
      specific disorders in the Korean population are between 5.2% and 4.2%.

      Among the different phobias, claustrophobia is the most common. This is a situational phobia
      and consists of an irrational fear that occurs when the person is in closed spaces such as an
      elevator, a tunnel, or some radiological test equipment such as an MRI. The person has an
      intense and irrational fear of being confined in a small space and not being able to escape.

      This situation has an implication from the point of view of public health because these
      people are sometimes unable to undergo an MRI since, in addition, they must be about 30
      minutes still in a small space. Therefore, this type of disorder leads on numerous occasions
      to the cancellation of the test, or to a premature termination, causing damage to the
      patient's health since, either the MRI is not performed, or they must undergo sedation or
      anesthesia.

      Magnetic resonance imaging is very useful in the detection and characterization of lesions.
      Some authors state that 37% of people who undergo an MRI have moderate to intense levels of
      anxiety. The prevalence of claustrophobia in the population is between 7.7% and 12.5%,
      although the frequency is higher among the female sex Approximately 1% of the population that
      requires an MRI rejects its performance or terminates it prematurely due to claustrophobia.
      Some researchers claim that 1.6% of patients finished the test prematurely due to
      claustrophobia, and, in addition, 3.8% underwent conscious sedation. These procedures
      increase the risk of complications, and in addition they increase the cost.

      The most common therapy to treat claustrophobia is cognitive behavioral therapy, with gradual
      exposure to closed or narrow spaces being the most widespread treatment.

      The use of some drugs, such as anxiolytics, is an option to reduce anxiety before imaging
      procedures. However, these drugs introduce some drawbacks such as all their adverse effects.
      For this reason, it is especially important to determine which are the non-pharmacological
      interventions that are most effective.

      In this context, new technologies such as Immersive Entertainment Glasses (IEG) allow
      patients to feel immersed in another reality, open and relaxing, which helps them overcome
      this situation. Some studies state that these strategies are useful for reducing the symptoms
      produced by claustrophobia. In addition, the use of virtual reality glasses as a distraction
      element is more effective than music therapy against claustrophobia.

      JUSTIFICATION Currently, at the Hospital Universitari Mútua de Terrassa, patients who report
      claustrophobia or fear of undergoing the test due to feeling confined or being unable to be
      inside the magnet, are referred to an open MRI scan at another health center. This means that
      patients must go to a private health center and undergo a test of inferior technical quality,
      since the open magnets have a low magnetic field, which limits the quality of the studies.
      The implementation of techniques that help reduce claustrophobia can avoid some sedation or
      anesthesia and, in addition, some people will be able to perform the test without
      pharmacological assistance and with higher quality images, which will improve their
      diagnosis.

      HYPOTHESIS AND OBJECTIVES MAIN OBJECTIVE To identify the effectiveness of the use of IEG
      during the performance of an MRI in patients who express claustrophobia.

      SPECIFIC OBJECTIVES

        1. Assess the quality of the images obtained from the studies carried out in the
           intervention group (IG) and in the control group (CG)

        2. Determine the number of tests that ended prematurely in the intervention group (IG) and
           in the control group (CG)

        3. To identify the levels of state-anxiety and trait-anxiety through the State Trait
           Anxiety Inventory questionnaire (A/E and A/R) before and after the resonance in the
           control group (CG) and the intervention group (IG)

        4. Compare the heart rate (HR) of the patients during the test with respect to the before
           value

        5. Assess the satisfaction of patients in the intervention group in relation to the use of
           IEG.

      HYPOTHESIS Implementing the use of IEG (Cinema Vision®, General Electric), with distracting
      content, in magnetic resonance imaging studies in patients who report fear of closed spaces,
      will reduce state-anxiety values, and increase the number of patients who will undergo the
      test successfully in at least 20%, compared to the previous situation.

      MATERIAL AND METHODS

      Design:

      Clinical trial with random assignment of patients to a control group and an intervention
      group.

      The study will be carried out at the facilities of the Diagnostic Imaging Department of the
      Hospital Universitari Mútua de Terrassa with a General Electric (GE) 1.5 Tesla MRI. For the
      IG, all examinations will be performed on an MRI to which the IEG have been added, and for
      the CG they will be performed on the same MRI or on another with the same characteristics
      without the installation of IEG.

      Study population:

      Patients who are defined as claustrophobic and who should undergo an MRI at the Hospital
      Universitari Mútua de Terrassa (HUMT).

      Sample size and justification:

      During 2019, a total of 252 patients were referred to another center to perform an MRI for
      referring claustrophobia. The sample will consist of 206 individuals, divided between an IG
      and a CG. With an alpha risk of 0.05 and a beta risk of less than 0.2, in unilateral
      contrast, with 103 subjects in each group, expecting a difference of 20% between the success
      of performing the test of the subjects of the control group and intervention. The estimated
      loss rate has been established at 0 because possible withdrawls will be exchanged with other
      participants.

      The selection of patients will be carried out consecutively in all the patients who are
      requested to have an MRI and who define themselves as claustrophobic and relate to the
      Diagnostic Imaging Department of HUMT and will be distributed randomly in the two groups.

      Data collection and intervention procedure Requests that arrive at the External Referral
      Service due to claustrophobia will be sent to the Diagnostic Imaging Department to be
      included in the study. Potential participants will first be contacted by phone to find out if
      they meet the study inclusion criteria and will be offered to participate in the study. These
      patients would have been referred for open MRI or sedation. The patient will receive an
      information sheet explaining the purpose of the study and an informed consent sheet. All
      patients who meet the inclusion criteria and sign the informed consent will be included in
      the study. The patient can revoke consent at any time. These patients will be scheduled on
      separate days from the rest to perform the test with the intervention of IEG or with
      professional support.

      To measure anxiety levels, the State-Trait Anxiety Questionnaire (STAI, State-Trait Anxiety
      Inventory Self Evaluation Questionnaire), will be used before the test, which will allow to
      differentiate between anxiety as a personality trait or as a state caused by the test (STAI-E
      and STAI-R). After the MRI, the STAI-E will be administered again, to compare the state of
      anxiety pre-post examination. The anxiety-state scale (A/E) is used to determine the levels
      of anxiety induced by experimental procedures with tension or stress load. A/E scores
      increase in response to different types of stress and decrease with relaxation techniques.
      This questionnaire is one of the classic measures to assess anxiety and is considered one of
      the references.

      Patients will be appointed to the CG or IG alternately and consecutively in the inclusion
      process. On the day of the examination, the patient will go to the MRI room and, if they
      belong to the IG, they will be fitted with IEG compatible with the MRI. The patient will view
      the content chosen by him or her during the test. Relaxing content will be offered with music
      and verbal instructions. The contents will be previously validated by the center's clinical
      psychologist with experience in this matter.

      During the test, the patient's heart rate will be monitored. Once the examination has been
      carried out, patient satisfaction will be assessed using an ad hoc questionnaire.

      Likewise, the quality of the images will be analyzed, and the data collected will be recorded
      in a specific database for this study.

      A pilot test will be carried out with 15 patients to detect possible limitations or
      improvements.

      Study variables:

      Independent variable: type of intervention performed, that is, IEG glasses or the usual
      procedure.

      Dependent variables:

        -  Percentage of patients who complete the MRI, that is, percentage of success.

        -  In addition, the quality of the images of the studies carried out will be assessed using
           a Likert scale (with values between 1 and 4), where value 1 is very low quality and
           non-assessable studies and value 4 is the expected maximum. This parameter will be
           assessed by the nurse performing the test.

        -  Variables regarding the IEG: in terms of satisfaction, patients will be asked if they
           would recommend the experience to other people, if they think that the IEG have helped
           them to carry out the test and if they have found it pleasant. This will be assessed
           through a Likert scale with 10 values, where 0 corresponds to a low assessment and 10 to
           the highest score.

        -  Other variables: anxiety values before and after the test (STAI pre-post RM), heart rate
           at the beginning and end.

      Control variables:

        -  Sociodemographic variables: initials of the patient's name and surnames, medical record
           number, age, sex.

        -  Variables regarding the test: diagnosis that caused the inquiry, part of the body
           explored, if it has a previous MRI, and if so, if it was an open or closed MRI, if parts
           of the test had to be repeated, or if the complete MRI could be performed
           (successfully).

      Sources of information and obtaining information The sources of information include the data
      provided by the patient and his or her clinical history, as well as the data that will be
      collected during the development of the study.

        -  Ad hoc questionnaire to collect the variables described

        -  STAI Questionnaire -State Trait Anxiety Inventory

      Statistical analysis:

      For the statistical analysis, the statistical program SPSS for Windows will be used. First, a
      descriptive study of the sample will be carried out using measures of central tendency and
      dispersion. The results of the sociodemographic and baseline anxiety variables of the
      participants in both groups will be compared to assess their comparability. The association
      of the variables will be studied using the Chi2 and Student's t tests, and the anxiety and
      heart rate variables will be analyzed using the McNemar test for proportions with paired
      data.

      Study limitations:

      The patient's anxiety to know the result of the test can influence the anxiety-state values
      and interfere with the concern that the patient presents for the diagnostic imaging test.

      Another possible limitation may be that the difference between patients who receive support
      through educational measures and EG is less than the 20% estimated according to the
      literature, and therefore, the sample should be larger.

      If the CG presents higher levels of anxiety than the IG, this will also imply a limitation of
      the study.
    

Intervention name(s): Virtual Immersive Reality Glasses; Conventional nurse support
Intervention type(s): Other; Other
Intervention description(s): 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.; Patients will be treated using the usual support technique to reduce anxiety in the Diagnostic Imaging service
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Immersive Entertainment Reality; Claustrophobia; Magnetic Resonance Imaging (MRI)