Clinical trial NCT04179916: Evaluation of Physiological Reactions in Virtual Reality
Official title: Evaluation of the Physical Reaction in Immersive Virtual Reality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Reality
Keywords: virtual reality
VR
HRV
thermal imaging
Lead sponsor: The Opole University of Technology
Sponsor class: OTHER
Collaborators: name: IRCCS San Camillo, Venezia, Italy
First posted: 2019-11-27
Enrollment: 17
Sex: ALL
Minimum age (years): 21
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: For this study it was assumed to expose healthy volunteers for stimuli in the immersive virtual reality
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of virtual medicine is to minimize direct contact and impact on human body during treatment. Taking into consideration the increasing accessibility of high quality electronic devices, their immense computing powers, and the continuously developing Internet infrastructure, the advancement in this area is only a matter of time. The project aims to analyze physiological reactions to stimuli in virtual reality in order to select appropriate stimulations for a group of pulmonary and cardiac patients.

Detailed description: In recent years, the literature has shown the results of many studies undertaking the possibility of applying new technologies in rehabilitation as elements of optimization, including Virtual Reality (VR). VR can be based on computer programs that use a three-dimensional camera or sensors placed on the body to read the patient's movements and transfer them to the screen in a computer-created environment. For the most part, VR research has focused on analyzing the therapeutic potential of typical virtual games, which are not designed for clinical use, but for entertainment and relaxation.

Rehabilitation in virtual reality has also become one of the common challenges for physiotherapists and IT specialists, who develop improvement programs dedicated to various diseases and illnesses. Numerous publications are available in the scientific literature, describing the possibilities of using VR as a diagnostic and therapeutic tool. The possibility of diagnostic application of the technology in motion analysis has been demonstrated. The use of VR in the analysis of respiratory mechanics and training of pulmonary patients has also been noted. Most of the available studies concern the rehabilitation of neurological patients. There are many studies available, including meta-analyses, which confirm that the best results of rehabilitation can be achieved through the use of traditional neurological rehabilitation combined with rehabilitation conducted in virtual reality. Only few papers describe physiological reactions, including heart rate variability (HRV) and thermovision diagnostics during stimulation in immersive virtual reality.

The aim of the study is to evaluate the physiological reactions of the organism in healthy subjects during stimulation in immersive virtual reality.

This study is focused on:

Monitoring physiological parameters including heart rate variability (HRV) and thermal imaging (TI) change in healthy subjects during stimulation in immersive virtual reality.

The result of proposed research may be the answer to the following questions:

1. What changes in heart rate variability occur during the stimulation of various types of stimuli in virtual reality?
2. Which alterations in body temperature, especially in the distal parts of the upper limb, occur during stimulation in virtual reality?

The evaluation session will be conduced in the following scheme in static seated position:

1. Preparation of the research equipment
2. Measurement without stimulation in virtual reality: HRV, TI - 6 minute
3. Measurement in virtual reality: HRV, TI - simulation of cold environment (snow, wind) - 6 minute
4. Measurement in virtual reality: HRV, TI - simulation of warm environment (the beach, the sea) - 6 minute
5. Measurement in virtual reality: HRV, TI - simulation of terrifying environment (a dark room, ghosts) - 6 minute
6. Measurement without stimulation in virulent reality: HRV, TI - 6 minute
7. Completion of the measurements

Eligibility criteria: Inclusion Criteria:

1. Age: 21-25

Exclusion Criteria:

1. diagnosed internal diseases
2. diseases and injuries of the locomotor system impairing the function of transport, especially injuries of the upper limb
3. claustrophobia
4. eye disorders

Primary outcomes:
measure: Thermal Imaging
timeFrame: 30 minutes
Secondary outcomes:
measure: Heart Rate Variability
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Venice
country: Italy
facility: San Camillo IRCCS
city: Głuchołazy
country: Poland
facility: The Ministry of the Interior and Administration Hospital
city: Opole
country: Poland
facility: Institute of Physiotherapy, Department of Physical Education and Physiotherapy, Opole University of Technology
Study officials:
affiliation: The Opole University of Technology
name: Sebastian Rutkowski, PhD
role: PRINCIPAL_INVESTIGATOR
References: