Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06596837
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-30
Brief Title:
Virtual Reality and Coping with Procedural Pain in Burn Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Virtual Reality and Coping with Procedural Pain in Burn Patients
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VRZPB
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 sro Patients meeting the selection criteria eg 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 04 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 participants39 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None