PainNCT04273958
Virtual Reality During Invasive Medical Procedures in an Emergency Department
A study testing Virtual reality helmet and Computer screen in people with Pain and Anxiety, run by Olivier Hugli at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Anxiety, Virtual Reality
- What is being tested?
- Virtual reality helmet and Computer screen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteSwitzerland
- Study dates
- 12 Feb 2020to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient whose care requires a medical procedure (suture, cast placement and repositioning, fracture reduction, paracentesis, thoracocentesis and lumbar puncture).
Who cannot join
- 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;
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, 1011
About this study
Official title: Impact of the Use of Virtual Reality on Pain and Anxiety Caused by Invasive Medical Procedures in the Emergency Department
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.
Read the 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
- Being tested
- Virtual reality helmet, Computer screen
- Keywords
- pain, virtual reality, anxiety, emergency department, procedural pain
- Medical subject headings
- Pain, Anxiety Disorders, Emergencies, Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality helmetDevice
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 screenDevice
During a painful procedure, the patient will watch the same virtual world, while wearing a noise-canceling headset with the same soothing music.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Virtual reality helmet |
| Computer screen | Active comparator | The comparator will consist in the screening of the same virtual world on the computer screen. Receives: Device: Computer screen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Anxiety intensity will be assessed immediately before and immediately after the procedure.
Secondary outcomes (6)
Telepresence
The first secondary outcome of this study will be patients' assessment of their telepresence perception using the iGroup Presence Questionnaire.
Measured: Telepresence feeling will be assessed immediately at the end of the procedure.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Perception by physicians of this technology will be assessed immediately at the end of the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start12 Feb 2020
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each patient will be randomized in a 1:1 ratio between the two arms of the study
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olivier Hugli
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne
- Responsible party
- Sponsor-investigator, Olivier Hugli, University of Lausanne Hospitals
- Investigators
- Olivier Hugli, MD, MPH, Principal investigator, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04273958
- Sponsor's protocol ID
- 2019-02276
- Other IDs
- 2019
- Status last verified
- Jul 2021
- First submitted
- 12 Feb 2020
- Last updated
- 19 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11844731Downey 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.
PubMed 23023471Sikka 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.
PubMed 30785860Jeffs 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.
PubMed 24823326Toledo 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.
PubMed 30679136Garrett 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.
PubMed 30333096Vanhaudenhuyse 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.
PubMed 30702397Li 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.
PubMed 11719743Singer 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.
PubMed 10339680Lang 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.
PubMed 24731852Page 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.
PubMed 22424915Bosso 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.
PubMed 35641354
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Use of Virtual Reality on Pain and Anxiety Caused by Invasive Medical Procedures in the Emergency Department
- ClinicalTrials.gov ID
- NCT04273958
- Acronym / sponsor ID
- 2019-02276
- Conditions
- Pain, Anxiety, Virtual Reality
- Keywords
- pain, virtual reality, anxiety, emergency department, procedural pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Olivier HugliUniversity, hospital or other
- Collaborators
- University of Lausanne
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 18 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Each patient will be randomized in a 1:1 ratio between the two arms of the study
| Arm | Type | Receives |
|---|---|---|
| Virtual reality | Experimental | Device: Virtual reality helmetThe 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. |
| Computer screen | Active comparator | Device: Computer screenThe comparator will consist in the screening of the same virtual world on the computer screen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient whose care requires a medical procedure (suture, cast placement and repositioning, fracture reduction, paracentesis, thoracocentesis and lumbar puncture).
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality helmetDuring a painful procedure, the patient will watch a virtual world in a virtual reality helmet, while wearing a noise-canceling headset with soothing music. | Device | Virtual reality |
| Computer screenDuring a painful procedure, the patient will watch the same virtual world, while wearing a noise-canceling headset with the same soothing music. | Device | Computer screen |
Primary outcome
Pain reduction
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).
Anxiety reduction
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).
6 secondary outcomes
Telepresence
Time frame: Telepresence feeling will be assessed immediately at the end of the procedure.
Level of dissociation
Time frame: Dissociation will be assessed immediately at the end of the procedure.
Patient's acceptance of the technology
Time frame: Acceptance will be assessed immediately at the end of the procedure.
Patient's comfort with the technology
Time frame: Comfort will be assessed immediately at the end of the procedure.
Motion sickness
Time frame: Motion sickness will be assessed immediately at the end of the procedure.
Perception by physicians of this technology
Time frame: Perception by physicians of this technology will be assessed immediately at the end of the procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
- Background: PubMed 11844731Bantick 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.
- Background: PubMed 23023471Downey 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.
- Background: PubMed 30785860Sikka 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.
- Background: PubMed 24823326Jeffs 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.
- Background: PubMed 30679136Toledo 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.
- Background: PubMed 30333096Garrett 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.
- Background: PubMed 30702397Vanhaudenhuyse 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.
- Background: PubMed 11719743Li 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.
- Background: PubMed 10339680Singer 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.
- Background: PubMed 24731852Lang 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.
- Background: PubMed 22424915Page 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.
- Derived from this study: PubMed 35641354Bosso 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Hugli, MD, MPH principal investigator
University of Lausanne Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality helmet and Computer screen in people with Pain and Anxiety, run by Olivier Hugli at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain reduction (time frame: Pain intensity will be assessed immediately before and immediately after the procedure.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04273958, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2021.