Virtual Reality and Coping with Procedural Pain in Burn Patients
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Burns
- 发起方
- Martin Zielina
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Pain Change During Dressing Changes - VR vs. Non-VR Phases
- 状态
- 已完成
- 最后更新
- 去年
概览
简要总结
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.
详细描述
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.
研究者
Martin Zielina
Head of Medical Ethics and Humanities Department, Second Faculty of Medicine
Charles University, Czech Republic
入排标准
入选标准
- •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
排除标准
- •Presence of facial burns
- •Acute psychotic illness
- •Neurodegenerative diseases
- •Other neurological conditions associated with potential cognitive impairment
结局指标
主要结局
Pain Change During Dressing Changes - VR vs. Non-VR Phases
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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).
次要结局
- Participant demographics (SEX)(From the first dressing change in the study to the second change within one week.)
- Participant demographics (AGE)(From the first dressing change in the study to the second change within one week.)
- Participant demographics (EDUCATION)(From the first dressing change in the study to the second change within one week.)
- Burn characteristics (HOW THE BURN WAS CAUSED)(From the first dressing change in the study to the second change within one week.)
- Burn characteristics (TBSA)(From the first dressing change in the study to the second change within one week.)
- Burn characteristics (LOCATION OF THE BURN)(From the first dressing change in the study to the second change within one week.)