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| Name | Class |
|---|---|
| University of Lausanne | OTHER |
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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.
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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual reality | Experimental | 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. |
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| Computer screen | Active Comparator | The comparator will consist in the screening of the same virtual world on the computer screen. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality helmet | Device | 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. |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olivier Hugli, MD, MPH | University of Lausanne Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire Vaudois (CHUV) | Lausanne | Canton of Vaud | 1011 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11844731 | Background | Bantick SJ, Wise RG, Ploghaus A, Clare S, Smith SM, Tracey I. Imaging how attention modulates pain in humans using functional MRI. Brain. 2002 Feb;125(Pt 2):310-9. doi: 10.1093/brain/awf022. | |
| 23023471 | Background | Downey LV, Zun LS. The impact of watching cartoons for distraction during painful procedures in the emergency department. Pediatr Emerg Care. 2012 Oct;28(10):1033-5. doi: 10.1097/PEC.0b013e31826cac1a. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| D004630 | Emergencies |
| D000073818 | Pain, Procedural |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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Each patient will be randomized in a 1:1 ratio between the two arms of the study
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The study will be a randomized controlled study. In order to minimize bias, one investigator will randomize the patient to one of the two groups, set up the medium to which the patient is assigned, and be present during the procedure. Patients will evaluate their pain and anxiety levels themselves using an electronic tablet, without the help of the investigator.
| Computer screen | Device | During a painful procedure, the patient will watch the same virtual world, while wearing a noise-canceling headset with the same soothing music. |
|
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. |
| 30785860 | Background | Sikka N, Shu L, Ritchie B, Amdur RL, Pourmand A. Virtual Reality-Assisted Pain, Anxiety, and Anger Management in the Emergency Department. Telemed J E Health. 2019 Dec;25(12):1207-1215. doi: 10.1089/tmj.2018.0273. Epub 2019 Feb 20. |
| 24823326 | Background | Jeffs D, Dorman D, Brown S, Files A, Graves T, Kirk E, Meredith-Neve S, Sanders J, White B, Swearingen CJ. Effect of virtual reality on adolescent pain during burn wound care. J Burn Care Res. 2014 Sep-Oct;35(5):395-408. doi: 10.1097/BCR.0000000000000019. |
| 30679136 | Background | Toledo Del Castillo B, Perez Torres JA, Morente Sanchez L, Escobar Castellanos M, Escobar Fernandez L, Gonzalez Sanchez MI, Rodriguez Fernandez R. [Reducing the pain in invasive procedures during paediatric hospital admissions: Fiction, reality or virtual reality?]. An Pediatr (Engl Ed). 2019 Aug;91(2):80-87. doi: 10.1016/j.anpedi.2018.10.019. Epub 2019 Jan 21. Spanish. |
| 30333096 | Background | Garrett B, Taverner T, Gromala D, Tao G, Cordingley E, Sun C. Virtual Reality Clinical Research: Promises and Challenges. JMIR Serious Games. 2018 Oct 17;6(4):e10839. doi: 10.2196/10839. |
| 30702397 | Background | Vanhaudenhuyse A, Ledoux D, Gosseries O, Demertzi A, Laureys S, Faymonville ME. CAN SUBJECTIVE RATINGS OF ABSORPTION, DISSOCIATION, AND TIME PERCEPTION DURING "NEUTRAL HYPNOSIS" PREDICT HYPNOTIZABILITY?: An exploratory study. Int J Clin Exp Hypn. 2019 Jan-Mar;67(1):28-38. doi: 10.1080/00207144.2019.1553765. |
| 11719743 | Background | Li SF, Greenwald PW, Gennis P, Bijur PE, Gallagher EJ. Effect of age on acute pain perception of a standardized stimulus in the emergency department. Ann Emerg Med. 2001 Dec;38(6):644-7. doi: 10.1067/mem.2001.119849. |
| 10339680 | Background | Singer AJ, Richman PB, Kowalska A, Thode HC Jr. Comparison of patient and practitioner assessments of pain from commonly performed emergency department procedures. Ann Emerg Med. 1999 Jun;33(6):652-8. |
| 24731852 | Background | Lang EV, Tan G, Amihai I, Jensen MP. Analyzing acute procedural pain in clinical trials. Pain. 2014 Jul;155(7):1365-1373. doi: 10.1016/j.pain.2014.04.013. Epub 2014 Apr 13. |
| 22424915 | Background | Page MG, Katz J, Stinson J, Isaac L, Martin-Pichora AL, Campbell F. Validation of the numerical rating scale for pain intensity and unpleasantness in pediatric acute postoperative pain: sensitivity to change over time. J Pain. 2012 Apr;13(4):359-69. doi: 10.1016/j.jpain.2011.12.010. Epub 2012 Mar 15. |
| 35641354 | Derived | Bosso L, Espejo T, Taffe P, Caillet-Bois D, Christen T, Berna C, Hugli O. Analgesic and Anxiolytic Effects of Virtual Reality During Minor Procedures in an Emergency Department: A Randomized Controlled Study. Ann Emerg Med. 2023 Jan;81(1):84-94. doi: 10.1016/j.annemergmed.2022.04.015. Epub 2022 May 28. |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |