Virtual Reality and Coping with Procedural Pain in Burn Patients
- Conditions
- BurnsVirtual RealityAnxietyPain
- Interventions
- Device: virtual reality
- Registration Number
- NCT06596837
- Lead Sponsor
- Martin Zielina
- Brief 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. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
- 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
- Presence of facial burns
- Acute psychotic illness
- Neurodegenerative diseases
- Other neurological conditions associated with potential cognitive impairment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description respondents exposed to highly immersive virtual reality (Cold River) virtual reality 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. respondents exposed to low-immersive virtual reality (static images) virtual reality The control group will have only static images of a snowy landscape in the virtual reality headset during one part of the dressing change.
- Primary Outcome Measures
Name Time Method Pain Change During Dressing Changes - VR vs. Non-VR Phases 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 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 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 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).
- Secondary Outcome Measures
Name Time Method Participant demographics (SEX) From the first dressing change in the study to the second change within one week. SEX We measured sex of participants. This nominal, binary variable has two levels: 0 (woman) and 1 (man).
Participant demographics (AGE) From the first dressing change in the study to the second change within one week. 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.
Participant demographics (EDUCATION) From the first dressing change in the study to the second change within one week. EDUCATION We measured highest level of education of participants. This nominal variable has three levels: primary school, secondary school, higher education.
Burn characteristics (HOW THE BURN WAS CAUSED) From the first dressing change in the study to the second change within one week. 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.
Burn characteristics (TBSA) From the first dressing change in the study to the second change within one week. 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.
Burn characteristics (LOCATION OF THE BURN) From the first dressing change in the study to the second change within one week. 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.
Trial Locations
- Locations (1)
Prague Burn Center, University Hospital Královské Vinohrady
🇨🇿Prague, Czech Republic