Cybersickness in Different Multisensory Conditions in Virtual Reality

NCT05534880 | Completed DMC

• 1 other identifier: UFDPar
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

Cybersickness (CS) is characterized as a type of visually induced motion sickness, similar to traditional motion sickness, with specific clinical presentations such as dizziness, eyestrain, oculomotor disorders, blurred vision and spatial disorientation. It can be triggered when experiencing virtual reality (VR), and it affects approximately 20% to 80% of individuals who use these resources. Furthermore, the underlying mechanisms of CS are not fully understood and the use of virtual environments that have become increasingly recurrent in several sectors deserves attention, as VR is becoming commonplace in methods and techniques of assessment, diagnosis and treatment. Objective: to analyze cortical electrophysiological activity using electroencephalography (EEG) in individuals with SC, under the influence of different audiovisual conditions. Methodology: The study is a double-blind randomized controlled clinical trial, the sample for survey satisfaction N= 10 participants, the public were university students from the Universidade Federal do Delta Parnaíba (UFDPar) of both sexes, aged between 18 to 28 years, those who agreed, underwent screening, those who met the criteria and fit, were randomized and allocated to one each of 02 conditions, (C1 - video only) and (C2 - associated with binaural audio), three times in each condition, with a duration of 10 minutes of immersion, with evaluation (pre) before (post) with QEEG and Sickness Questionnaire (SSQ), exposure to virtual content was on regular alternate days, with a 24-hour interval between each virtual exposure, at the end of each condition, there will be a 14-day washout and crossover between the conditions. The study will be carried out under all cleaning and prevention care in the fight against the Covid-19 pandemic, data collection will be at the Brain Mapping and Functionality Laboratory (LAMCEF) of the Federal University of Delta do Parnaíba, Piauí, Brazil. Results: The condition with binaural stimulation is expected to promote neuromodulation and reduction of CS symptoms, compared to the control condition.

Conditions

Cybersickness; Reduced Sensation

Keywords

cybersickness; virtual reality; binaural beats; electroencephalography

Outcome Measures

Primary Outcomes (1)

• analysis of electrophysiological activity

  Analisys of absolute power of the Delta band frequencies of the frontal and temporand regions of the brain.

  In pre-intervention procedures, the baseline cortical electroencephalography will be analyzed for 5 minutes. After immersion, the same procedures will be performed

Secondary Outcomes (1)

• Analysis of symptoms through the SSQ questionnaire

  In the pre-intervention procedures, before the cortical analysis, the SSQ instrument will be applied, and immediately after each session, the subjective assessment instrument will be applied

Study Arms (2)

Virtual Reality

ACTIVE COMPARATOR

Condition 01 - the participants will be induced to CS, they will be immersed in a roller coaster simulation video, lasting 10 minutes, there will be 03 sessions on alternate days with a 24-hour interval between each session, before and after each session will be applied the SSQ questionnaire subjective assessment and EEG objective assessment.

Other: Binaural beats

Virtual reality and binaural beats

EXPERIMENTAL

Condition 02 - the participants will be induced to CS, they will be immersed in a roller coaster simulation video associated with audio with binaural beat, lasting 10 minutes, there will be 03 sessions on alternate days with a 24-hour interval between each session, before and after each session, the SSQ subjective assessment questionnaire and the objective assessment EEG will be applied.

Other: Binaural beats

Interventions

Binaural beats OTHER

Condition 02- will be used binaural beats, since they are referred through studies with the ability to drive neural oscillations in the beat frequency through differential hemispheric synchronization frequencies, it is expected that a neuromodulation and repercussion of the symptomatological reduction of CS.

Virtual Reality; Virtual reality and binaural beats

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must have normal or corrected to normal vision
• Participant must have a history of visually induced motion sickness

You may not qualify if:

• Cannot present vestibular disorders
• Claustrophobia
• Epileptic seizures
• Musculoskeletal disorders
• psychoactive drug use
• Neurological disorders
• Considerable hearing loss

Sponsors & Collaborators

• Federal University of Piaui: lead

Study Sites (2)

Federal University of the Delta Parnaíba

Parnaíba, Piauí, 64202-020, Brazil

Location

Federal University of the Parnaiba Delta

Parnaíba, Piauí, 64202-020, Brazil

Location

Related Links

• Dissociating vestibular and somatosensory contributions to spatial orientation
• The Potential of Immersive Virtual Reality for Cognitive Training in Elderly
• Simulator Sickness Questionnaire: tradução e adaptação transcultural
• A Failure to Enhance EEG Power and Emotional Arousal
• The role of virtual reality in improving motor performance as revealed by EEG: a randomized clinical trial
• Humans integrate visual and haptic information in a statistically optimal fashion
• The Effects of Binaural and Monoaural Beat Stimulation on Cognitive Functioning in Subjects with Different Levels of Emotionality
• Vestibular-somatosensory interactions: A mechanism in search of a function?
• Too Real to Be Virtual: Autonomic and EEG Responses to Extreme Stress Scenarios in Virtual Reality
• Efficacy of binaural auditory beats in cognition, anxiety, and pain perception: a meta-analysis
• Multisensory integration in self motion perception. Multisensory Research
• Cybersickness: A multisensory integration perspective
• Vection in virtual reality modulates vestibular-evoked myogenic potentials
• Binaural interaction of a beating frequency following response
• A meta-analysis of the virtual reality problem: Unequal effects of virtual reality sickness across individual differences

MeSH Terms

Conditions

Hypesthesia

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Victor H. Bastos, Ph. D

  Federal University of the Parnaiba Delta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants will not be aware of the intention of each of the immersion conditions, and will be randomized through a program for each of the conditions, by a researcher external to the research, and sorted through an opaque envelope, the participants and the researcher, not will know in which condition they will be allocated, only on the day of the draw, each participant will be allocated in the condition and the researcher will not be aware of which condition the participant will be immersed in (condition 01 - video only) or (condition 02 - video associated with binaural beat) .
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Undegraduate

Model Details: The study will be a double-blind randomized controlled clinical trial, with university students of both sexes in the city of Parnaíba - PI, volunteers who present cybersickness will be evaluated, those who meet the admission criteria will be randomized and allocated and will be immersed in three conditions, in these conditions the volunteers will be immersed in VR to induce symptoms, where bimodal conditions will be analyzed and compared to analyze the variable electrophysiological activity and the influence of multisensory conditions.

Study Record Dates

• First Submitted: September 4, 2022
• First Posted: September 10, 2022
• Study Start: November 8, 2022
• Primary Completion: May 10, 2023
• Study Completion: July 9, 2023
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)