Virtual Reality During Invasive Medical Procedures in an Emergency Department

NCT ID: NCT04273958

Last Updated: 2021-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-12
• Study Completion Date: 2020-09-30

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).

Conditions

Pain; Anxiety; Virtual Reality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Virtual reality

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.

Group Type: EXPERIMENTAL

Virtual reality helmet

Intervention Type: 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.

Computer screen

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

Group Type: ACTIVE_COMPARATOR

Computer screen

Intervention Type: DEVICE

During a painful procedure, the patient will watch the same virtual world, while wearing a noise-canceling headset with the same soothing music.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lausanne

OTHER

Sponsor Role: collaborator

Olivier Hugli

OTHER

Sponsor Role: lead

Responsible Party

Olivier Hugli

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Olivier Hugli, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Lausanne Hospitals

Locations

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, Switzerland

Countries

Switzerland

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: DERIVED

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Other Identifiers

2019-02276

Identifier Type: -

Identifier Source: org_study_id