Virtual Reality During Invasive Medical Procedures in an Emergency Department

NCT04273958 | Completed

• 1 other identifier: 2019-02276
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Anxiety; Virtual Reality

Keywords

pain; virtual reality; anxiety; emergency department; procedural pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Telepresence

  Telepresence feeling will be assessed immediately at the end of the procedure.

• Level of dissociation

  Dissociation will be assessed immediately at the end of the procedure.

• Patient's acceptance of the technology

  Acceptance will be assessed immediately at the end of the procedure.

• Patient's comfort with the technology

  Comfort will be assessed immediately at the end of the procedure.

• Motion sickness

  Motion sickness will be assessed immediately at the end of the procedure.

Study Arms (2)

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.

Device: Virtual reality helmet

Computer screen

ACTIVE COMPARATOR

The comparator will consist in the screening of the same virtual world on the computer screen.

Device: Computer screen

Interventions

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.

Virtual reality

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.

Computer screen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient whose care requires a medical procedure (suture, cast placement and repositioning, fracture reduction, paracentesis, thoracocentesis and lumbar puncture).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Olivier Hugli: lead
• University of Lausanne: collaborator

Study Sites (1)

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (12)

• 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.

  PMID: 11844731 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.

  PMID: 23023471 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.

  PMID: 30785860 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.

  PMID: 24823326 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.

  PMID: 30679136 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.

  PMID: 30333096 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.

  PMID: 30702397 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.

  PMID: 11719743 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.

  PMID: 10339680 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.

  PMID: 24731852 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.

  PMID: 22424915 BACKGROUND

• 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.

  PMID: 35641354 DERIVED

MeSH Terms

Conditions

Pain; Anxiety Disorders; Emergencies; Pain, Procedural

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Disease Attributes; Pathologic Processes

Study Officials

• Olivier Hugli, MD, MPH

  University of Lausanne Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Each patient will be randomized in a 1:1 ratio between the two arms of the study

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 18, 2020
• Study Start: February 12, 2020
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: July 19, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)