Virtual Reality During Invasive Medical Procedures in an Emergency Department

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04273958
• Other study ID #: 2019-02276
• Status: Completed
• Phase: N/A
• Start date: February 12, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: July 2021
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Emergencies
• Pain
• Virtual Reality

Intervention

Device:
• Virtual reality helmet
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.
• Computer screen
During a painful procedure, the patient will watch the same virtual world, while wearing a noise-canceling headset with the same soothing music.

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois (CHUV)	Lausanne	Vaud

Sponsors (2)

Lead Sponsor	Collaborator
Olivier Hugli	University of Lausanne

Country where clinical trial is conducted

Switzerland, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Lang EV, Tan G, Amihai I, Jensen MP. Analyzing acute procedural pain in clinical trials. Pain [Internet]. 2014 Jul [cited 2019 Nov 20];155(7):1365-73. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4409872/

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. — View Citation

Pagé 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. — View Citation

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. — View Citation

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. — View Citation

Toledo Del Castillo B, Pérez Torres JA, Morente Sánchez L, Escobar Castellanos M, Escobar Fernández L, González Sánchez MI, Rodríguez Fernández 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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.