Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, 1011, Switzerland
NCT Number: NCT04273958
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Lausanne, Canton of Vaud, 1011, Switzerland
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 :
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
During a painful procedure, the patient will watch the same virtual world, while wearing a noise-canceling headset with the same soothing music.
Time frame: Pain intensity will be assessed immediately before and immediately after the procedure.
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).
Time frame: Anxiety intensity will be assessed immediately before and immediately after the procedure.
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).
Time frame: Telepresence feeling will be assessed immediately at the end of the procedure.
The first secondary outcome of this study will be patients' assessment of their telepresence perception using the iGroup Presence Questionnaire.
Time frame: Dissociation will be assessed immediately at the end of the procedure.
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).
Time frame: Acceptance will be assessed immediately at the end of the procedure.
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).
Time frame: Comfort will be assessed immediately at the end of the procedure.
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).
Time frame: Motion sickness will be assessed immediately at the end of the procedure.
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).
Time frame: Perception by physicians of this technology will be assessed immediately at the end of the procedure.
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).
Olivier Hugli
Other
Impact of the Use of Virtual Reality on Pain and Anxiety Caused by Invasive Medical Procedures in the Emergency Department
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