Virtual Reality and Coping with Procedural Pain in Burn Patients

NCT06596837 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2024-09-19

No results posted yet for this study

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

Interventions

DEVICE

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.).

Sponsors & Collaborators

  • Vascular surgery, University hospital Královské Vinohrady, Prague

    collaborator OTHER
  • Palacký University, Olomouc

    collaborator UNKNOWN
  • VR Space

    collaborator UNKNOWN
  • Martin Zielina

    lead OTHER

Principal Investigators

  • Martin Zielina, Dr. · Charles University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-15
Primary Completion
2022-05-01
Completion
2023-08-04

Countries

  • Czechia

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06596837 on ClinicalTrials.gov