Virtual Reality and Coping with Procedural Pain in Burn Patients

NCT ID: NCT06596837

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-15
• Study Completion Date: 2023-08-04

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.

Conditions

Burns; Virtual Reality; Anxiety; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

respondents exposed to highly immersive virtual reality (Cold River)

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.

Group Type: EXPERIMENTAL

virtual reality

Intervention Type: DEVICE

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.).

respondents exposed to low-immersive virtual reality (static images)

The control group will have only static images of a snowy landscape in the virtual reality headset during one part of the dressing change.

Group Type: OTHER

virtual reality

Intervention Type: DEVICE

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.).

Changing dressings without the use of virtual reality

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

virtual reality

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.).

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vascular surgery, University hospital Královské Vinohrady, Prague

OTHER

Sponsor Role: collaborator

Palacký University, Olomouc

UNKNOWN

Sponsor Role: collaborator

VR Space

UNKNOWN

Sponsor Role: collaborator

Martin Zielina

OTHER

Sponsor Role: lead

Responsible Party

Martin Zielina

Head of Medical Ethics and Humanities Department, Second Faculty of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Martin Zielina, Dr.

Role: PRINCIPAL_INVESTIGATOR

Charles University

Locations

Prague Burn Center, University Hospital Královské Vinohrady

Prague, Czech Republic, Czechia

Countries

Czechia

Related Links

https://osf.io/gmv79

OSF pre-registration

Other Identifiers

TL03000090

Identifier Type: -

Identifier Source: org_study_id