Virtual Reality and Coping with Procedural Pain in Burn Patients

NCT06596837 | Completed

• 1 other identifier: TL03000090
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns; Virtual Reality; Anxiety; Pain

Keywords

Virtual Reality; Pain Reduction; Anxiety; Burn Patients; Presence; Dressing Changes

Outcome Measures

Primary Outcomes (4)

• Pain Change During Dressing Changes - VR vs. Non-VR Phases

  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).

  From the first dressing change in the study to the second change within one week.

• Anxiety Change During Dressing Changes - VR vs. Non-VR Phases

  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.

  From the first dressing change in the study to the second change within one week.

• Presence Change During Dressing Changes - VR vs. Non-VR Phases

  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.

  From the first dressing change in the study to the second change within one week.

• Nausea Change During Dressing Changes - VR vs. Non-VR Phases

  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).

  From the first dressing change in the study to the second change within one week.

Secondary Outcomes (6)

• 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.

Other Outcomes (3)

• CURRENT MEDICATION

  From the first dressing change in the study to the second change within one week.

• GAME PLAYING EXPERIENCE

  From the first dressing change in the study to the second change within one week.

• VR EXPERIENCE

  From the first dressing change in the study to the second change within one week.

Study Arms (3)

respondents exposed to highly immersive virtual reality (Cold River)

EXPERIMENTAL

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.

Device: virtual reality

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

OTHER

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

Device: virtual reality

Changing dressings without the use of virtual reality

NO INTERVENTION

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.

Interventions

virtual reality 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 highly immersive virtual reality (Cold River); respondents exposed to low-immersive virtual reality (static images)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Martin Zielina: lead
• Vascular surgery, University hospital Královské Vinohrady, Prague: collaborator
• Palacký University, Olomouc: collaborator
• VR Space: collaborator

Study Sites (1)

Prague Burn Center, University Hospital Královské Vinohrady

Prague, Czech Republic, 100 00, Czechia

Location

Related Links

• OSF pre-registration

MeSH Terms

Conditions

Burns; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Wounds and Injuries; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Martin Zielina, Dr.

  Charles University, Czech Republic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Medical Ethics and Humanities Department, Second Faculty of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: September 19, 2024
• Study Start: September 15, 2021
• Primary Completion: May 1, 2022
• Study Completion: August 4, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: start date: September 30, 2024 end date: September 30, 2029
• Access Criteria: The anonymized dataset is accessible on the Open Science Framework (OSF) at https://osf.io/embrj/?view\ only=5a74f28a0bee4c388d415596bf159bad and can also be requested via martin.zielina@lfmotol.cuni.cz.

Locations

CZ (1)