Clinical trial NCT06596837: Virtual Reality and Coping with Procedural Pain in Burn Patients
Official title: Virtual Reality and Coping with Procedural Pain in Burn Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Virtual Reality
Anxiety
Pain
Keywords: Virtual Reality
Pain Reduction
Anxiety
Burn Patients
Presence
Dressing Changes
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
Collaborators: name: Vascular surgery, University hospital Královské Vinohrady, Prague
name: Palacký University, Olomouc
name: VR Space
First posted: 2024-09-19
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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\&#39; 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Presence of facial burns
* Acute psychotic illness
* Neurodegenerative diseases
* Other neurological conditions associated with potential cognitive impairment

Primary outcomes:
measure: Pain Change During Dressing Changes - VR vs. Non-VR Phases
timeFrame: From the first dressing change in the study to the second change within one week.
measure: Anxiety Change During Dressing Changes - VR vs. Non-VR Phases
timeFrame: From the first dressing change in the study to the second change within one week.
measure: Presence Change During Dressing Changes - VR vs. Non-VR Phases
timeFrame: From the first dressing change in the study to the second change within one week.
measure: Nausea Change During Dressing Changes - VR vs. Non-VR Phases
timeFrame: From the first dressing change in the study to the second change within one week.
Secondary outcomes:
measure: Participant demographics (SEX)
timeFrame: From the first dressing change in the study to the second change within one week.
measure: Participant demographics (AGE)
timeFrame: From the first dressing change in the study to the second change within one week.
measure: Participant demographics (EDUCATION)
timeFrame: From the first dressing change in the study to the second change within one week.
measure: Burn characteristics (HOW THE BURN WAS CAUSED)
timeFrame: From the first dressing change in the study to the second change within one week.
measure: Burn characteristics (TBSA)
timeFrame: From the first dressing change in the study to the second change within one week.
measure: Burn characteristics (LOCATION OF THE BURN)
timeFrame: From the first dressing change in the study to the second change within one week.
Other outcomes:
measure: CURRENT MEDICATION
timeFrame: From the first dressing change in the study to the second change within one week.
measure: GAME PLAYING EXPERIENCE
timeFrame: From the first dressing change in the study to the second change within one week.
measure: VR EXPERIENCE
timeFrame: From the first dressing change in the study to the second change within one week.
Locations:
city: Prague
country: Czech Republic
facility: Prague Burn Center, University Hospital Královské Vinohrady
Study officials:
affiliation: Charles University
name: Martin Zielina, Dr.
role: PRINCIPAL_INVESTIGATOR
References: