Using Virtual Reality Simulations to Alleviate Fear and Anxiety in Children Awaiting MRI: A Small-Scale Randomized Controlled Trial

doi:10.21203/rs.3.rs-4266322/v1

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Using Virtual Reality Simulations to Alleviate Fear and Anxiety in Children Awaiting MRI: A Small-Scale Randomized Controlled Trial

https://doi.org/10.21203/rs.3.rs-4266322/v1

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Purpose:

Up to 75% of paediatric patients experience anxiety and distress before undergoing new medical procedures. Virtual reality is an interesting avenue for alleviating the stress and fear of paediatric patients due to its ability to completely immerse the child in the virtual world and thus expose them to the sights and sounds of an MRI before undergoing the exam. We aimed to explore the impact of virtual reality exposure on reducing fear and anxiety in paediatric patients scheduled to undergo an MRI.

Methods:

We conducted a prospective randomized control trial in a tertiary paediatric hospital over three weeks. Inclusion criteria comprised children aged 4 to 14 undergoing MRI without medical contraindications for VR use. Thirty patients (16 in VR, 14 in control) were included in the study. The VR group experienced a simulated MRI room with typical sounds for up to 5 minutes before their actual MRI. Fear and anxiety were measured using the FACES scale before and after MRI for the control group as well as after VR exposure for the VR group.

Results:

The VR group exhibited a significant reduction in anxiety post-VR exposure regarding the upcoming MRI (p = 0.009).

Conclusions:

VR exposure effectively reduces pre-MRI anxiety in paediatric patients who are about to undergo the exam. This research is in line with previous findings, however there is need for further investigation in this field using larger and MRI-naïve groups of patients.

MRI

Virtual reality

paediatrics

anxiety

stress

Virtual reality (VR) has been used in paediatrics in multiple settings, including needle-involved procedures, pre-operative settings, and burn-care amongst others. In the setting of needle-involved procedures, a meta-analysis has shown the effectiveness of VR in helping children overcome the pain [1]. These studies have shown that VR can be successfully applied in paediatric settings, therefore prompting us to examine if it may be applied in the field of radiology.

Magnetic resonance imaging (MRI), provides an interesting use case for the application of VR in paediatrics as children may experience fear and be uncomfortable during the exam prompting them to move and reduce the quality of the exam or even render it entirely non-diagnostic [2]. Patient cooperation is fundamental during MRI examinations, which have an average time of 20 minutes, but may last longer in complicated cases and if we consider the patient preparation. Up to 50% of exams on 2-to-5-year-old patients and 35% of exam son 6-to-7-year-old patients are prematurely terminated, which is why patients are routinely sedated under general anaesthesia from the age of 6 months to around 5 years [2]. Anaesthesia should be considered for all the patients who may not tolerate the exam, such as autistic or mentally disabled children. However, as the long-term effects of anaesthesia on children have yet to be conclusively established it is generally avoided if possible [3]. It should also be noted that both anaesthesia and the need to repeat non-diagnostic MRI sequences or the whole examination are costly in terms of time, staff and resources [2].

Reports estimate that 50 to 75% of paediatric patients experience elevated anxiety and distress before undergoing new medical procedures [4]. It has been shown that patients with previous exposure to MRIs may become used to the exam and have improved experiences in the future [5].

Previous attempts at reducing paediatric anxiety facing an MRI for the first time have been made, such as by providing explanations of the upcoming procedure or children’s books about the experience of an MRI and even allowing children to undergo a simulated MRI experience using a mock-MRI [2]. These mock-MRIs can either be old machines or purpose-built models, which allow the exploration of the MRI without the additional need for standard MRI-related precaution [2]. However, mock-MRIs are resource-heavy in terms of price, staff requirements and often require a dedicated room, reducing their ability to be used in real world circumstances [6].

Various methods of preparing children for MRIs, such as informational videos, tunnels, vibrating mats with MRI audio simulations and mock-scale MRIs to demonstrate the procedure have been shown to work, with some studies showing a reduction in the need for anaesthesia from 27 to 47% if appropriate preparation is done [6].

VR is an interesting avenue for alleviating the stress and fear of paediatric patients due to its ability to completely immerse the child in the virtual world. Furthermore, as children are often at ease with technology, due to the ubiquity of screens and video games, they are often receptive to the use of such solutions. Though two previous trials have been conducted looking at MRI exposure using VR in the past to reduce anxiety, they were either much smaller groups or over a far longer period of pre-MRI exposure [7, 8]. We have conducted this prospective randomized control trial with the aim of examining the effect of VR exposure before an MRI on the fear and anxiety of paediatric patients, with a secondary outcome of examining the success rate of the MRI exam between the groups.

The prospective study was run in a tertiary paediatric hospital for three weeks and was accepted by the local ethical committee (P 2023/151 / CCB B4062023000089).

The inclusion criteria were children aged 4 to 14 and children undergoing an MRI for any reason. This age range was chosen as children younger than this would not have been able to wear the heaset and it was reasoned that older children would derive little benefit from the use of VR. Exclusion criteria were children who were undergoing their MRI with general anaesthesia, children who were unable to communicate, children who were unable to wear the VR heaset or had any contraindication for doing so (known epileptics etc.) as well as patients unable to speak either French, Dutch, German or English.

The parents or the legal guardian of the children were contacted beforehand by telephone by the secretary to obtain an email address with which the informed consent documents could be sent beforehand as well as a short explanatory document regarding what the VR experience would consist of. The parents/legal guardians were encouraged to read the documentation alongside their children, for whom an extra piece of simplified explanatory documentation was included. The parents were also encouraged to come an hour before their scheduled appointment so that there would be enough time to enrol them in the study. Patients were provided no incentives for enrolment into the study nor were they given any assurances as to whether they would be part of the VR group or the control group.

Once the children arrived for the exam we divided the children into pairs based on their time of arrival. We then used a random number generator from 1 to 10 in order to assign the first patient, with the paired patient being assigned to the other group in order to maintain parity. This was repeated for each patient pair. Patients obtaining an even number were included in the VR, whilst those with an odd number were not. As the patients were randomly assigned to their groups, they were not age matched. The patients were told which group they would be part of and subsequently administered the first round of questions.

Those who would be exposed to the VR simulation were first asked to rate their fear and anxiety regarding the upcoming exam using the FACES scale and then asked if they had any reasons to explain their feelings. The FACES scale consists of six rounded emoticon-like faces with emotions ranging from happy to sad, with corresponding values of 0 to 10. We decided upon this scale as Shockey et al. reported that, as children have great difficulty in separating pain and anxiety, the FACES scale can successfully be used to measure anticipatory anxiety [9]. We considered using the Children’s Fear Scale (CFS), however, as Bannink Mbazzi et al. reported that children of African origin had difficulties relating to the faces used in the CFS due to their Caucasian features we decided it would be inappropriate as we anticipated having many patients of African origin [10]. On the contrary, we reasoned that the FACES scale, based on emoticon-like faces, would cause minimal ethnic bias and the children would likely be more familiar with the emoticon-like emotions displayed.

The patients then wore the VR heaset for up to five minutes, after which the same questions were asked. They then underwent the MRI, following which the same questions were asked. The patients in the non-VR group were asked the questions before and after the MRI. The sequence of events is summarized in flowchart of Fig. 1.

The VR heaset being used was a Meta Quest 2 (Meta, California, USA) with an aftermarket strap designed to improve the fit for the patient (Fig. 2).

Patients were seated, the heaset was worn, and the controllers were then placed in their hands with brief instructions on how to use them. The virtual MRI room was created using the Unity game engine (Unity Technologies, San Francisco, USA) version 2021a.

The VR experience consisted of a recreation of the MRI room in which they would undergo their exam with typical MRI sequence noises. The simulation began with the child located inside the machine (Fig. 3), but they were able to move around the room and explore it using the joysticks (Figs. 4, 5 and Video 1).

The interaction level was limited to moving around the room. The sound volume was chosen by the child and set at a level that would be both comfortable for the child and allow communication with them during the experience in case they decided that they wanted to remove the heaset for any reason. Patients underwent their actual MRI exam within 10 minutes of the end of their virtual reality experience.

Statistical analysis was performed using SPSS for Windows version 28.0.1.1. (IBM Corporation, Armonk, USA). A p-value of < 0.05 was considered significant. We performed a Mann-Whitney test to compare the fear and anxiety scores of the VR and non-VR groups. We performed paired sample t-tests to compare the results of each group at different time points. We performed a χ²-test to determine if there was a significant difference in the success rates of the MRI between the VR and non-VR groups.

Despite the study being run for three weeks, with an average of 12 MRIs being conducted daily, only 30 children were included in the study. One reason was that many children did not meet the inclusion criteria regarding age. Another reason was that, on multiple occasions, parents initially accepted to participate via telephone but then refused on the day. When this occurred, it was mainly either due to time constraints (being late for the MRI or having another appointment scheduled soon after) or not having understood the experiment when explained over the phone and not having read the explanatory material sent to them beforehand by email. In these cases, the children were not included in the study. There were also multiple instances of parents accepting on the phone but it being discovered that the parents and children were unable to speak any of the three national languages or English to an adequate standard and were therefore unable to be included in the study as it was impossible to explain the study to a level that it was deemed that consent could be reasonably obtained. On other occasions, the children came for their MRI exam unaccompanied or accompanied by another sibling who was not deemed eligible to sign an informed consent form in the stead of their parents.

Thirty patients were included in this trial, with 16 being assigned to the VR group and 14 being assigned to the control group. The VR group was 64% male (9 of 14), and the control group was 50% male (7 of 14), with 53% males overall. The ages of the patients from each group are displayed in figure 6.

Fig 6 Bar chart of the age distribution of patients in each group

We recorded the fear and anxiety levels of the patients at all three time points for the VR group and at both time points for the control group (Table 1). We found no significant differences between the VR and non-VR groups regarding fear and anxiety before the MRI and after the MRI (Table 2). We found no differences between the post-VR and pre-MRI control groups in terms of fear ( p = 0.45) or anxiety ( p = 0.27).

We then compared the ratings of fear and anxiety within each group at different time points. There was a significant difference between the baseline anxiety and the post-VR anxiety with a p = 0.009 (Table 3 and Supplementary table 1). We found no differences in terms of fear or anxiety between the other time points in the VR group or between the fear and anxiety ratings in the control group before and after the MRI exam (Table 4 and Supplementary table 2).

In the VR group, 15/16 (93%) exams were considered technical successes, defined as exams without motion artefacts which limited the interpretability of one of more sequences. In the children in the control group, 10/14 (71%) exams were considered successes. This result was not significant (p = 0.102).

Of the children who were included in the study, 18/30 had previous MRI examination experience, ranging from a single previous MRI to one instance of a patient having had 32 previous MRIs. There were no significant differences in the number of patients having undergone previous MRIs in each group with 11/16 (69%) of VR patients having had one and 7/14 (50%) of the control group (p = 0.296).

When questioned as to the reasons for their fear and anxiety, some patients said that they had little fear and anxiety regarding the examination itself due to their habituation. However, they were instead fearful and anxious because of the anticipation of the placement of the intravenous line needed for contrast injection.

Nine of sixteen children who wore the VR heaset rated the experience, with an average rating of 7.4/10 (range 2-10). Three children, two aged 14 and one aged 13, found the VR experience to be boring due to the lack of interactive elements as they felt too old to benefit from it.

Of the patients who wore the VR heaset, all but two of them wore it for the full 5 minutes allowed. Of those who removed the heaset, the first was an 8-year-old male who wore it for 2 minutes and 40 seconds, removing the heaset as they had enough and stating that they did not need it as they had undergone over 10 previous MRIs. The second patient, a 14-year-old female wore it for 3 minutes and 30 seconds and removed the heaset as wanted to see the real room again but said they enjoyed the VR experience and would do it again. The second patient also self-reported having undergone many MRI exams in the past but the exact number was unknown.

There were no instances of clinically significant side effects in the children who wore the VR headset, though in the case of two younger patients the heaset was found to be ill-fitting, but it was considered to still be useable for the experience.

During the MRI exam, one patient who was suffering from sickle cell anemia and was hospitalized for painful crises experienced one during their MRI, leading to its premature termination and preventing the use of the questionnaire after the exam, resulting in an incomplete dataset for that patient. No other exams were prematurely terminated.

Many attempts have been made to use virtual reality in the settings of MRIs, however few yielded results that are comparable to our own due to having different study designs or lack of analogous data.

Nakarada-Kordic et al. explored the use of a VR simulation of an MRI in comparison to a mock-MRI in healthy adult volunteers, finding no significant differences regarding anxiety experienced by the patients between the two [5]. However, they concluded that VR has the potential to be a more accessible alternative to mock MRIs and could be used to improve patient experience and reduce the amount of costly aborted exams [5].

Stunden et al. created a more elaborate VR experience aimed at children with the aim of making them pass a simulated MRI exam [4]. They compared their VR experience to their standard preparatory manual and their child life program to see which achieved the highest MRI simulator success (judged as less than 4 mm of movement during the six-minute simulated MRI exam), reduced child and caregiver anxiety as well as improved their procedure overall using a number of metrics [4]. In their VR experience, they guided the patients through the whole process of entering the hospital’s radiology department and the steps that go into the preparation for the MRI exam [4]. They also included a mini-game requiring the patient to stay still despite distractions in order to win [4]. Like our results, which did not demonstrate any differences in terms of MRI success rates between the groups, they did not find any significant differences between their three groups in terms of success rates of their virtual MRI test [4]. Interestingly, they also had most patients who declared themselves to be anxiety free at all stages of the process, like what we found during our experiment [4]. Furthermore, they found that there were no differences in caregiver anxiety between the groups but found that the time taken to prepare the patients was significantly different amongst the groups, with the VR preparation taking the longest [4]. When they compared the children’s satisfaction, the child life program was preferred, with 90% approval, followed by the VR and preparation manual at 80% and 73.5% respectively. Similarly, our patients also showed a high degree of satisfaction with the virtual reality experience, though we did not attempt to gauge the satisfaction of the control group.

Ashmore et al. used a 360-degree video viewable using VR glasses, which was downloaded by patients and used before their visit [6]. In their video Ashmore et al. took a similar approach to Stunden et al. by allowing patients to see the entire process of the MRI exam, starting with the arrival in the radiology department, experiencing the exam and ending with saying goodbye at the end [4, 6]. Contrary to our reasoning, Ashmore et al. believed that using a 360-degree video rather than computer-generated content would facilitate scalability, whereas we reasoned that a VR experience created using the software would, in the future, allow each department to create a setting that matched their MRI exactly [6]. They were able to take footage from within their 1.5T MRI machine, finding that their camera was still functional despite having some ferromagnetic components [6]. They used the video with five patients that were initially thought to require general anaesthesia for their exam but, after the use of their solution, were able to undergo the exam without the need for anaesthesia [6].

Brown et al. created a VR experience like ours by creating a 3D recreation of their MRI room that was viewable from a smartphone but did not proceed to perform an experiment to judge its benefit [11]. They believed that virtual reality was superior to 360-degree video due to the distortions and therefore planned to make the VR room in order to alleviate claustrophobia in their patients [11].

In 2017 Liszio et al created a virtual MRI simulation, using a smartphone-based VR device, where the patients, aged 8 to 12, was introduced to an MRI via a narrative involving penguins as the protagonists [8]. Once the patients entered the VR experience, they were first informed about the MRI, observed the MRI, saw the MRI in use on the penguins and then experienced the MRI and were told to hold still for 5 minutes [8]. They first conducted a study on seven children, five of which had prior MRI experience, to see if VR would be accepted, finding that they found the experience enjoyable [8]. They performed a second experiment on thirteen children, nine of which had previous MRI experience, aged 8 to 15 years old [8]. Of the six patients in their experimental group, all had previous MRI experience [8]. They measured the patient’s anxiety using a State-Trait Anxiety Inventory for Children questionnaire at identical intervals as in our study (pre-VR, post-VR and post-MRI for the experimental group and pre-MRI and post-MRI for the control group) [8]. Their results were very similar to ours, finding no significant differences between the scores of the children at different time points or between the groups [8]. They found a trend of decreasing anxiety scores between the pre-VR and post-VR scores but, unlike our study, their results were not significant [8].

In 2020 Liszio et al also performed another test using similar software to their prior experiment on 29 children to whom they sent a package at home which allowed them to train for the MRI over an average of 14 days, once again using a smartphone-based system [7]. However, this system was far more time consuming and complicated, requiring patients to participate from home using a guardian’s smartphone mounted in a VR device, answer repeated questionnaires, remember a “courage formula” intended to help them be brave and complete a booklet [7]. They found significant reductions in anxiety as well as negative sentiment towards the exam, whilst seeing positive sentiment significantly increased [7]. With this paper they showed that repeated and prolonged exposure to the setting of an MRI in VR is better than one-shot exposure [7].

The research of Liszio et al is particularly interesting as their first paper was comparable to ours and yielded similar results and the second paper, conducted over a longer time-frame, showed a significant benefit. We believe that this suggests that longer term, and repeated, exposure should be favoured over the single exposure approach.

In 2020, Liszio et al. also created “Penguinauts: Star Journey”, an in-bore MRI game, which allowed children to either have a passive or interactive virtual reality game experience within the MRI and during the examination itself but were unable to test their solution due to restrictions imposed by the COVID-19 pandemic [2].

Our study had limitations, which we found mainly to be related to the setting of a tertiary paediatric hospital. Firstly, it is impossible to perform blinding in such studies, as patients obviously are aware of which group they are in. Secondly, due to the recruitment problems and limited timeframe, the number of enrolled patients was limited to 30. As our hospital treats many chronic patients, most MRI slots are occupied by patients who are undergoing follow-up exams and therefore a large proportion of children included in the study had previously undergone MRIs, limiting their initial anxiety and fear due to their habituation. Our study was also limited by the shyness of many children, who were unable to provide answers beyond “I don’t know” when questioned as to the reasons for their fear and anxiety regarding the MRI exam. The equipment we used also resulted in a limited ability to follow what the child was doing during the MRI experience, with researchers being unable to directly see what the child was experiencing. In one instance, the patient managed to exit the simulation by reverting to the main menu of the Meta Quest 2. This was promptly rectified, with the timer being stopped whilst the simulation was re-initiated.

Furthermore, although we believe that our simulation provided an adequate approximation of our MRI room, it was by no means a perfect recreation or completely realistic. It is possible that a simulation with a more detailed environment and better image quality, which was limited by our hardware, may yield more promising results. Finally, future projects should consider including motion activated features, such as the simulation starting with a specific input or examination table entering the MRI machine when the patient lies down, which we believe would be feasible using the motion detectors that are integrated in most modern VR headsets.

In conclusion, we found that providing a 5-minute virtual reality simulation of our MRI to paediatric patients significantly reduced their anxiety regarding the upcoming exam compared to their baseline anxiety. However, we did not find any significant differences between the anxiety and fear ratings between the measurements at other time points or between the virtual reality group and the control group.

Data collected during this trial can be made available upon reasonable request.

Author Contribution

The conceptualisation of the study was performed by T.S., G.B.,M.P.,G.N.,A.DL. and P.S.The methodology was created by T.S., G.B.,M.P.,G.N.,A.DL.,The investigation was performed by T.S., G.B.,M.P.,G.N.,A.DL.,P.S.The data was curated by T.S. The analysis was conducted by T.S. The drafting of the initial manuscript was done by T.S., G.B.,M.P.,G.N.,A.DL.,The reviewing and editing of the manuscript was done by T.S., G.B.,G.N.,A.DL.,P.S.Supervision was provided by G.B.,M.P.,G.N.,A.DL. and P.S.All the authors reviewed and approved the final manuscript.

Acknowledgement

We would like to thank Mr Telly Makinguet and Ms Chantal Molle for their invaluable help with the recruitment of the patients and helping with the setup and data collection. This study would not have been possible without their help.

Data Availability

All the data can be provided upon reasonable request.

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Tables 1-4 is available in the Supplementary Files section.

No competing interests reported.

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You are reading this latest preprint version

Using Virtual Reality Simulations to Alleviate Fear and Anxiety in Children Awaiting MRI: A Small-Scale Randomized Controlled Trial

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Supplementary Files

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