BurnsVRZPBNCT06596837
Virtual Reality and Coping with Procedural Pain in Burn Patients
A study testing virtual reality in people with Burns and Virtual Reality, run by Martin Zielina at 1 site in Czechia.
Trial summary
The main aim of the project is to reduce the feeling of procedural pain (when changing bandages) in burn patients through a developed and pilot-verified application for virtual reality (hereinafter VR). The first study on this topic was conducted in the US on two pediatric patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns, Virtual Reality, Anxiety
- What is being tested?
- virtual reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteCzechia
- Study dates
- 15 Sep 2021to 4 Aug 2023
- 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
- Sustained a thermal injury covering a total body surface area of 0.4% or more
- Actively receiving therapy for the injury
- Proficient in the Czech language
Who cannot join
- Presence of facial burns
- Acute psychotic illness
- Neurodegenerative diseases
- Other neurological conditions associated with potential cognitive impairment
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Prague Burn Center, University Hospital Královské Vinohrady
Prague, Czech Republic, 100 00
About this study
The main aim of the project is to reduce the feeling of procedural pain (when changing bandages) in burn patients through a developed and pilot-verified application for virtual reality (hereinafter VR). The first study on this topic was conducted in the US on two pediatric patients. In addition to pharmacological pain therapy, there are a number of non-pharmacological options (eg, relaxation techniques) that are based on distracting attention from the feeling of pain. VR appears to be the most promising of these options and, in addition to distraction, it also reduces anxiety and depressive symptoms and enhances patient cooperation. The studies also agree on the beneficial role of immersivity; a sense of immersion in VR.
Read the detailed description
The project was preceded by a pilot verification to select an appropriate approach for implementing the research design, including the development of a new VR application that took into account current technological advancements in this field. As part of the pilot verification, a custom application was created based on experiences with existing VR applications designed for therapeutic purposes for burn trauma patients in collaboration with Space s.r.o. Patients meeting the selection criteria (e.g., extent of burns, consent to participate in the study, and other relevant factors) were included in the study after the second dressing change in the dressing room. It was during these dressing changes that procedural pain occurred, first during the removal of old dressings and then during the removal of necrotic tissue and the application of new dressings. Each of these painful procedures was divided into two parts: 1) removal of old dressings; 2) removal of necrotic tissue and application of new dressings. In the study, pain sensation was repeatedly measured using the NPRS (Numeric Pain Rating Scale) and BSPAS (Burns Specific Pain Anxiety Scale) for both parts in at least 30 patients. Before each dressing change, it was randomly determined whether the VR would be used during the first part (removal of old dressings) or only during the second part (removal of necrotic tissue and application of new dressings). Additionally, the part involving VR was further assessed using a short immersion inventory, the Igroup Presence Questionnaire (IPQ). In the end, it was possible to evaluate the effect of VR on pain management during dressing changes in patients with burn trauma. The investigators will continue to measure several variables. The feeling of nausea will be assessed in a virtual environment on an ordinal scale from 0, indicating no nausea, to 10, indicating the worst imaginable nausea. Age will be recorded and categorized into six ordinal groups ranging from 18 to 70 years and older. The type of medications participants are currently taking will be recorded, categorized into six levels, including options ranging from none to five types of medications, such as strong opioids and analgesics. The total body surface area (TBSA) burned will be measured, with categories ranging from 0.4% to 45% or more. Additionally, the investigators will assess how the burn was caused, with categories including electro trauma, scalding, chemical trauma, frostbite, and flame burns. They will also evaluate participants\' gaming and VR experience, determining whether participants consider themselves gamers, play games regularly, or have personal experience with virtual reality. These measurements aim to provide a detailed understanding of the participants´ conditions and their responses during the study.
- Conditions
- Burns, Virtual Reality, Anxiety, Pain
- Being tested
- virtual reality
- Keywords
- Virtual Reality, Pain Reduction, Anxiety, Burn Patients, Presence, Dressing Changes
- Medical subject headings
- Burns, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual realityDevice
The investigators manipulated the following two variables within the experimental design:
Immersion in the virtual environment. This was a nominal variable with two levels: a low-immersive environment (Other group) and a highly immersive environment (Experimental group) using the Cold River application.
Order of virtual reality (VR) deployment during the first session. This was also a nominal variable with two levels: VR during the first part of the dressing change (removing the dressing) and VR during the second part of the dressing change (cleaning the wound and applying a new dressing). In each subsequent session, the order of VR deployment was swapped for each participant.
The values of both variables were assigned to participants according to their numbers (e.g., 1. highly immersive, VR first; 2. low immersive, VR first; 3. highly immersive, VR last; 4. low immersive, VR last, etc.).
| Study group | Role | What they receive |
|---|---|---|
| respondents exposed to highly immersive virtual reality (Cold River) | Experimental | The experimental group will have a virtual reality (VR) application Cold River in the VR headset that will significantly enhance the sense of immersion (e.g., realistic environment, interactive capabilities) during one part of the dressing change. Receives: Device: virtual reality |
| respondents exposed to low-immersive virtual reality (static images) | Other | The control group will have only static images of a snowy landscape in the virtual reality headset during one part of the dressing change. Receives: Device: virtual reality |
| Changing dressings without the use of virtual reality | No intervention | In the study, each dressing change, whether in the experimental or control group, will include a part where the participant will not wear a virtual reality (VR) headset. Each participant will have two different sessions, and the part of the dressing change without the VR headset will occur at a different stage of the change in each session. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Change During Dressing Changes - VR vs. Non-VR Phases
NPRS (Numeric Pain Rating Scale) We measured the intensity of the pain. The eleven levels of this ordinal variable: are from 0 (not at all) to 10 (the worst I can imagine).
Measured: From the first dressing change in the study to the second change within one week.
Anxiety Change During Dressing Changes - VR vs. Non-VR Phases
BSPAS (Burn Specific Pain Anxiety Scale) We measured pain-related and anticipatory anxiety. The eleven levels of this ordinal variable have nine items: from 0 (not at all) to 10 (the worst I can imagine), ranging from 0 to 90. The higher, the worse.
Measured: From the first dressing change in the study to the second change within one week.
Presence Change During Dressing Changes - VR vs. Non-VR Phases
IPQ (Igroup Presence Questionnaire) We measured the sense of presence experienced in a virtual environment. The seven levels of this ordinal variable have fourteen items. The IPQ measures overall presence (General Presence), ranging from 0 to 7, and three distinct components: Spatial Presence (ranging from 0 to 35), Involvement (ranging from 0 to 28), and Realism (ranging from 0 to 28). Each scale ranges from 0 to 7.
Measured: From the first dressing change in the study to the second change within one week.
Nausea Change During Dressing Changes - VR vs. Non-VR Phases
Nausea We measured nausea in a virtual environment. The eleven levels of this ordinal variable are: from 0 (not at all) to 10 (the worst I can imagine).
Measured: From the first dressing change in the study to the second change within one week.
Secondary outcomes (6)
Participant demographics (SEX)
SEX We measured sex of participants. This nominal, binary variable has two levels: 0 (woman) and 1 (man).
Measured: From the first dressing change in the study to the second change within one week.
Participant demographics (AGE)
AGE We measured the age of participants. This ordinal variable has six levels: 18 to 28, 29 to 39, 40 to 48, 49 to 59, 60 to 69, 70 and over.
Measured: From the first dressing change in the study to the second change within one week.
Participant demographics (EDUCATION)
EDUCATION We measured highest level of education of participants. This nominal variable has three levels: primary school, secondary school, higher education.
Measured: From the first dressing change in the study to the second change within one week.
Burn characteristics (HOW THE BURN WAS CAUSED)
HOW THE BURN WAS CAUSED We measured how the burn was caused. This nominal variable has six levels : Electro trauma, scalding, chemical trauma, frostbite, flame burns and others.
Measured: From the first dressing change in the study to the second change within one week.
Burn characteristics (TBSA)
TBSA We measured the Total Body Surface Area (TBSA) burned. This categorical variable is divided into ten levels: 0.4% to 4.99%, 5% to 9.99%, 10% to 14.99%, 15% to 19.99%, 20% to 24.99%, 25% to 29.99%, 30% to 34.99%, 35% to 39.99%, 40% to 44.99%, and 45% or more.
Measured: From the first dressing change in the study to the second change within one week.
Burn characteristics (LOCATION OF THE BURN)
We measured location of the burn. The levels of this nominal variable correspond to any part of the body, based on the Lund and Browder (LB) chart.
Measured: From the first dressing change in the study to the second change within one week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Sep 2021
- Primary completion1 May 2022
- Study completion4 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The investigators employed a repeated-measures crossover design. Participants were divided into Experimental: respondents exposed to highly immersive virtual reality (Cold River) or Other: respondents exposed to low-immersive virtual reality (static images) groups based on the sequence of their informed consents: even-numbered participants were assigned to the Other group, and odd-numbered participants to the Experimental group. Each participant attended two consecutive wound care sessions, which consisted of dressing removal, wound cleaning, and the application of new dressings. The investigators incorporated virtual reality (VR) into one segment of each session: either during the initial phase (dressing removal) or the concluding phase (wound cleaning and new dressing application). In their subsequent sessions, participants experienced VR during the segment opposite to their initial session.
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martin Zielina
- Sponsor type
- University, hospital or other
- Collaborators
- Vascular surgery, University hospital Královské Vinohrady, Prague, Palacký University, Olomouc, VR Space
- Responsible party
- Sponsor-investigator, Martin Zielina, Charles University, Czech Republic
- Investigators
- Martin Zielina, Dr., Principal investigator, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596837
- Sponsor's protocol ID
- TL03000090
- Acronym
- VRZPB
- Status last verified
- Sep 2024
- First submitted
- 30 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality and Coping with Procedural Pain in Burn Patients
- ClinicalTrials.gov ID
- NCT06596837
- Acronym / sponsor ID
- VRZPB / TL03000090
- Conditions
- Burns, Virtual Reality, Anxiety, Pain
- Keywords
- Virtual Reality, Pain Reduction, Anxiety, Burn Patients, Presence, Dressing Changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Martin ZielinaUniversity, hospital or other
- Collaborators
- Vascular surgery, University hospital Královské Vinohrady, Prague, Palacký University, Olomouc, VR Space
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 4 Aug 2023 (actual)
- First posted
- 19 Sep 2024 (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.
The main aim of the project is to reduce the feeling of procedural pain (when changing bandages) in burn patients through a developed and pilot-verified application for virtual reality (hereinafter VR). The first study on this topic was conducted in the US on two pediatric patients. In addition to pharmacological pain therapy, there are a number of non-pharmacological options (eg, relaxation techniques) that are based on distracting attention from the feeling of pain. VR appears to be the most promising of these options and, in addition to distraction, it also reduces anxiety and depressive symptoms and enhances patient cooperation. The studies also agree on the beneficial role of immersivity; a sense of immersion in VR.
Detailed description
The project was preceded by a pilot verification to select an appropriate approach for implementing the research design, including the development of a new VR application that took into account current technological advancements in this field. As part of the pilot verification, a custom application was created based on experiences with existing VR applications designed for therapeutic purposes for burn trauma patients in collaboration with Space s.r.o. Patients meeting the selection criteria (e.g., extent of burns, consent to participate in the study, and other relevant factors) were included in the study after the second dressing change in the dressing room. It was during these dressing changes that procedural pain occurred, first during the removal of old dressings and then during the removal of necrotic tissue and the application of new dressings. Each of these painful procedures was divided into two parts: 1) removal of old dressings; 2) removal of necrotic tissue and application of new dressings. In the study, pain sensation was repeatedly measured using the NPRS (Numeric Pain Rating Scale) and BSPAS (Burns Specific Pain Anxiety Scale) for both parts in at least 30 patients. Before each dressing change, it was randomly determined whether the VR would be used during the first part (removal of old dressings) or only during the second part (removal of necrotic tissue and application of new dressings). Additionally, the part involving VR was further assessed using a short immersion inventory, the Igroup Presence Questionnaire (IPQ). In the end, it was possible to evaluate the effect of VR on pain management during dressing changes in patients with burn trauma. The investigators will continue to measure several variables. The feeling of nausea will be assessed in a virtual environment on an ordinal scale from 0, indicating no nausea, to 10, indicating the worst imaginable nausea. Age will be recorded and categorized into six ordinal groups ranging from 18 to 70 years and older. The type of medications participants are currently taking will be recorded, categorized into six levels, including options ranging from none to five types of medications, such as strong opioids and analgesics. The total body surface area (TBSA) burned will be measured, with categories ranging from 0.4% to 45% or more. Additionally, the investigators will assess how the burn was caused, with categories including electro trauma, scalding, chemical trauma, frostbite, and flame burns. They will also evaluate participants\' gaming and VR experience, determining whether participants consider themselves gamers, play games regularly, or have personal experience with virtual reality. These measurements aim to provide a detailed understanding of the participants´ conditions and their responses during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The investigators employed a repeated-measures crossover design. Participants were divided into Experimental: respondents exposed to highly immersive virtual reality (Cold River) or Other: respondents exposed to low-immersive virtual reality (static images) groups based on the sequence of their informed consents: even-numbered participants were assigned to the Other group, and odd-numbered participants to the Experimental group. Each participant attended two consecutive wound care sessions, which consisted of dressing removal, wound cleaning, and the application of new dressings. The investigators incorporated virtual reality (VR) into one segment of each session: either during the initial phase (dressing removal) or the concluding phase (wound cleaning and new dressing application). In their subsequent sessions, participants experienced VR during the segment opposite to their initial session.
| Arm | Type | Receives |
|---|---|---|
| respondents exposed to highly immersive virtual reality (Cold River) | Experimental | Device: virtual realityThe experimental group will have a virtual reality (VR) application Cold River in the VR headset that will significantly enhance the sense of immersion (e.g., realistic environment, interactive capabilities) during one part of the dressing change. |
| respondents exposed to low-immersive virtual reality (static images) | Other | Device: virtual realityThe control group will have only static images of a snowy landscape in the virtual reality headset during one part of the dressing change. |
| Changing dressings without the use of virtual reality | No intervention | –In the study, each dressing change, whether in the experimental or control group, will include a part where the participant will not wear a virtual reality (VR) headset. Each participant will have two different sessions, and the part of the dressing change without the VR headset will occur at a different stage of the change in each session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Sustained a thermal injury covering a total body surface area of 0.4% or more
- Actively receiving therapy for the injury
- Proficient in the Czech language
Key exclusion criteria (4 listed)
- Presence of facial burns
- Acute psychotic illness
- Neurodegenerative diseases
- Other neurological conditions associated with potential cognitive impairment
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 realityThe investigators manipulated the following two variables within the experimental design: Immersion in the virtual environment. This was a nominal variable with two levels: a low-immersive environment (Other group) and a highly immersive environment (Experimental group) using the Cold River application. Order of virtual reality (VR) deployment during the first session. This was also a nominal variable with two levels: VR during the first part of the dressing change (removing the dressing) and VR during the second part of the dressing change (cleaning the wound and applying a new dressing). In each subsequent session, the order of VR deployment was swapped for each participant. The values of both variables were assigned to participants according to their numbers (e.g., 1. highly immersive, VR first; 2. low immersive, VR first; 3. highly immersive, VR last; 4. low immersive, VR last, etc.). | Device | respondents exposed to highly immersive virtual reality (Cold River), respondents exposed to low-immersive virtual reality (static images) |
Primary outcome
Pain Change During Dressing Changes - VR vs. Non-VR Phases
Time frame: From the first dressing change in the study to the second change within one week.
NPRS (Numeric Pain Rating Scale) We measured the intensity of the pain. The eleven levels of this ordinal variable: are from 0 (not at all) to 10 (the worst I can imagine).
Anxiety Change During Dressing Changes - VR vs. Non-VR Phases
Time frame: From the first dressing change in the study to the second change within one week.
BSPAS (Burn Specific Pain Anxiety Scale) We measured pain-related and anticipatory anxiety. The eleven levels of this ordinal variable have nine items: from 0 (not at all) to 10 (the worst I can imagine), ranging from 0 to 90. The higher, the worse.
Presence Change During Dressing Changes - VR vs. Non-VR Phases
Time frame: From the first dressing change in the study to the second change within one week.
IPQ (Igroup Presence Questionnaire) We measured the sense of presence experienced in a virtual environment. The seven levels of this ordinal variable have fourteen items. The IPQ measures overall presence (General Presence), ranging from 0 to 7, and three distinct components: Spatial Presence (ranging from 0 to 35), Involvement (ranging from 0 to 28), and Realism (ranging from 0 to 28). Each scale ranges from 0 to 7.
Nausea Change During Dressing Changes - VR vs. Non-VR Phases
Time frame: From the first dressing change in the study to the second change within one week.
Nausea We measured nausea in a virtual environment. The eleven levels of this ordinal variable are: from 0 (not at all) to 10 (the worst I can imagine).
6 secondary outcomes
Participant demographics (SEX)
Time frame: From the first dressing change in the study to the second change within one week.
Participant demographics (AGE)
Time frame: From the first dressing change in the study to the second change within one week.
Participant demographics (EDUCATION)
Time frame: From the first dressing change in the study to the second change within one week.
Burn characteristics (HOW THE BURN WAS CAUSED)
Time frame: From the first dressing change in the study to the second change within one week.
Burn characteristics (TBSA)
Time frame: From the first dressing change in the study to the second change within one week.
Burn characteristics (LOCATION OF THE BURN)
Time frame: From the first dressing change in the study to the second change within one week.
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 Sep 2024.
- OSF pre-registrationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
Martin Zielina, Dr. principal investigator
Charles University, Czech Republic
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 in people with Burns and Virtual Reality, run by Martin Zielina at 1 site in Czechia.
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 3 inclusion and 4 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 Sep 2024. 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 Czechia. 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 Change During Dressing Changes - VR vs. Non-VR Phases (time frame: From the first dressing change in the study to the second change within one week.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2024; AzTrials last refreshed its copy on 6 Nov 2026.