Virtual Reality During Invasive Medical Procedures in an Emergency Department

Study Overview
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Brief Summary
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This randomized controlled study aims to investigate whether, during a painful medical procedure in an emergency department (ED), the diffusion of a virtual environment through a virtual reality (VR) headset worn by the patient has a greater impact on the patient's pain and anxiety levels than the diffusion of an identical environment through a computer screen. The study design allows differentiating the impact of the medium from that of the media. The feeling of telepresence of patients in both groups and its association with the impact of the medium will also be investigated. In addition, this study aims to explore whether the wearing of VR headphones is considered comfortable and acceptable by patients.

Detailed Description
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Consultation in a hospital ED and the provided treatments are stressful, as it usually results from an unexpected event that has a negative impact on health. Also, an ED is a noisy and chaotic environment, which can increase anxiety and pain sensitivity related to certain medical procedures. Indeed, the conditions under which medical and surgical procedures are performed have an impact on the patient's experience: pain can be more intense if the patient is stressed and focused on the medical procedure. The well-being of patients, especially during these invasive medical procedures, can be improved by adjusting the conditions in which the procedure is performed. The literature and clinical observations show that distraction is a very effective non-pharmacological strategy to reduce pain and anxiety. The use of measures such as television, music or other audiovisual media has been shown to decrease pain during painful medical procedures in ED. The perception of pain competes with other stimuli, whether sensory or psychological. This competition is all the more effective as the number of senses involved and their intensity increases. However, these traditional media have little distractive power. They capture partially the patient's attention and the patient can easily refocus on the ongoing medical procedure. These traditional media do not produce an immersive experience. According to this principle, the analgesic effect of VR is expected to be greater than that provided by passive distractions such as watching a film on television, as demonstrated during wound dressing replacement in burned patients. Also, the patient's emotional state plays a role in her/his distractibility during a procedure. Therefore, the ideal distractive method should involve a maximum of senses (vision/hear/touch/...) and affects the patient's emotions to compete with the unpleasant stimulus. VR is a recent technology that offers a multi-sensory (vision, hearing), immersive and three-dimensional experience. It offers an active immersion in a virtual world, letting the patient navigate in a virtual world, leading to a greater perceived presence in this virtual environment (telepresence). Telepresence allows the patient to be a co-constructor of the experience. It differentiates VR from other cognitive and distractive techniques. VR can thus distract patients more effectively from the conditions under which they receive their treatment by procuring a superior distraction. However, studies on the impact of VR during invasive or painful procedures have left some unanswered questions that limit its unrestricted use in the ED : Most of the studies have been conducted in children. Different technologies have been used by different studies, precluding direct comparisons between studies; There are few data on the impact of VR applied in an emergency department with adult patients; The differentiation between the effect of the media (images used) and the effect of the medium (technology used) is often neglected; In this study, the investigators will attempt to demonstrate the potential superiority of VR, using a commercial VR device projecting a virtual environment designed specifically for medical use by a private company, and available to any group or ED wishing to apply this technology. The investigators will include adult patients requiring a painful medical procedure. In addition, patients will be randomized between two groups, both exposed to the same virtual environment (media) but screened in two different technologies (medium).

Official Title
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Impact of the Use of Virtual Reality on Pain and Anxiety Caused by Invasive Medical Procedures in the Emergency Department

Conditions
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Pain, Anxiety, Virtual Reality

Intervention / Treatment
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* Device: Virtual reality helmet
* Device: Computer screen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient whose care requires a medical procedure (suture, cast placement and repositioning, fracture reduction, paracentesis, thoracocentesis and lumbar puncture). Exclusion Criteria: Unstable patient (e.g., admitted to the intensive care unit or deemed unstable by the physician in charge); Patients without decision-making capacity or with whom it is difficult to communicate: Altered mental status (e.g., cognitive impairment, mental retardation, acute confusional state, acute psychosis). Intoxication, Drug abuse Patient unable to communicate in French at a level sufficient to give informed consent and answer questions about pain and anxiety; Patient who is hard of hearing; Patient unable to see films on screen or in VR due to vision problems (e.g., blindness or without his/her glasses). Patients unable to understand the use of the EVA strips; Part of the body where the altered procedure is to be performed (e.g. sensitivity disorder, lymphedema...) Patient with a head injury that prevents the use of RV helmet; Intended use of sedation analgesia with a dissociative agent (midazolam, ketamine, propofol). Incarcerated patient; Patient transferred from another hospital; Patient who participated in this study at a previous consultation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Each patient will be randomized in a 1:1 ratio between the two arms of the study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality<br>The intervention will consist of the use of a virtual reality helmet during the painful medical procedure. The content has been developed by a private company with the goal of providing a relaxing and soothing exploration of a virtual world. | Device: Virtual reality helmet<br>* During a painful procedure, the patient will watch a virtual world in a virtual reality helmet, while wearing a noise-canceling headset with soothing music.<br>|
| Active Comparator: Computer screen<br>The comparator will consist in the screening of the same virtual world on the computer screen. | Device: Computer screen<br>* During a painful procedure, the patient will watch the same virtual world, while wearing a noise-canceling headset with the same soothing music.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain reduction | The primary outcome of this study will be the patients' self-assessment of their pain intensity by Visual Analog Scale (VAS) on a 100-mm ruler during the procedure in the emergency department. The ruler will be presented to the patients on a digital tablet, and the patients will place the slider along the 100-mm line anchored at each end by the two labels no pain / worst pain imaginable. The numerical value measured in millimeters will be automatically integrated into the electronic Case Report Form (CRF). | Pain intensity will be assessed immediately before and immediately after the procedure. | 
| Anxiety reduction | The primary outcome of this study will be the patients' self-assessment of their anxiety intensity by Visual Analog Scale (VAS) on a 100-mm ruler during the procedure in the emergency department. The ruler will be presented to the patients on a digital tablet, and the patients will place the slider along the 100-mm line anchored at each end by the two labels no anxiety / worst anxiety imaginable. The numerical value measured in millimeters will be automatically integrated into the electronic Case Report Form (CRF). | Anxiety intensity will be assessed immediately before and immediately after the procedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Telepresence | The first secondary outcome of this study will be patients' assessment of their telepresence perception using the iGroup Presence Questionnaire. | Telepresence feeling will be assessed immediately at the end of the procedure. | 
| Level of dissociation | The next secondary outcomes will be patients' assessment of their level of dissociation by a specific question; it will also be measured by testing the understanding of the procedure by a Visual Analog Scale (VAS) on a 100-mm ruler. The ruler will be presented to the patients on a digital tablet, and the patients will place the slider along the 100-mm line. The ruler for the understanding of the procedure will be anchored by the terms no understanding / complete understanding.The numerical value measured in millimeters will be automatically integrated into the electronic Case Report Form (CRF). | Dissociation will be assessed immediately at the end of the procedure. | 
| Patient's acceptance of the technology | Patients'acceptance will be measured by a Visual Analog Scale (VAS) on a 100-mm ruler. The ruler will be presented to the patients on a digital tablet, and the patients will place the slider along the 100-mm line. The ruler for the acceptance of the technology will be anchored by the terms not acceptable / completely acceptable.The numerical value measured in millimeters will be automatically integrated into the electronic Case Report Form (CRF). | Acceptance will be assessed immediately at the end of the procedure. | 
| Patient's comfort with the technology | Patient's comfort with the technology will be measured by a Visual Analog Scale (VAS) on a 100-mm ruler. The ruler will be presented to the patients on a digital tablet, and the patients will place the slider along the 100-mm line. The ruler for the comfort with the technology will be anchored by the terms very comfortable / very uncomfortable.The numerical value measured in millimeters will be automatically integrated into the electronic Case Report Form (CRF). | Comfort will be assessed immediately at the end of the procedure. | 
| Motion sickness | Motion sickness is one of the side-effect of a virtual reality headset. Patient's motion sickness will be measured by a Visual Analog Scale (VAS) on a 100-mm ruler. The ruler will be presented to the patients on a digital tablet, and the patients will place the slider along the 100-mm line. The ruler for the comfort with the technology will be anchored by the terms no motion sickness / gratest motion sickness imaginable.The numerical value measured in millimeters will be automatically integrated into the electronic Case Report Form (CRF). | Motion sickness will be assessed immediately at the end of the procedure. | 
| Perception by physicians of this technology | Physicians' perception of the usefulness provided by the technology will be assessed by two questions. The first question will address the help provided by the technology (Did the technology used help you during the procedure? Possible answers will be yes, no, neutral). The second question will enquire if the question has hindered the physician (Did the technology used hinder you during the procedure?Possible answers will be yes, no, neutral). | Perception by physicians of this technology will be assessed immediately at the end of the procedure. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, virtual reality, anxiety, emergency department, procedural pain