Clinical trial NCT04273958: Virtual Reality During Invasive Medical Procedures in an Emergency Department
Official title: Impact of the Use of Virtual Reality on Pain and Anxiety Caused by Invasive Medical Procedures in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anxiety
Virtual Reality
Keywords: pain
virtual reality
anxiety
emergency department
procedural pain
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
Collaborators: name: University of Lausanne
First posted: 2020-02-18
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each patient will be randomized in a 1:1 ratio between the two arms of the study
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Pain reduction
timeFrame: Pain intensity will be assessed immediately before and immediately after the procedure.
measure: Anxiety reduction
timeFrame: Anxiety intensity will be assessed immediately before and immediately after the procedure.
Secondary outcomes:
measure: Telepresence
timeFrame: Telepresence feeling will be assessed immediately at the end of the procedure.
measure: Level of dissociation
timeFrame: Dissociation will be assessed immediately at the end of the procedure.
measure: Patient's acceptance of the technology
timeFrame: Acceptance will be assessed immediately at the end of the procedure.
measure: Patient's comfort with the technology
timeFrame: Comfort will be assessed immediately at the end of the procedure.
measure: Motion sickness
timeFrame: Motion sickness will be assessed immediately at the end of the procedure.
measure: Perception by physicians of this technology
timeFrame: Perception by physicians of this technology will be assessed immediately at the end of the procedure.
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois (CHUV)
state: Vaud
Study officials:
affiliation: University of Lausanne Hospitals
name: Olivier Hugli, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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