NCT03577288

Brief Summary

Recently, researchers in the field of cognitive psychology have shown a great interest in Virtual Reality (VR). Indeed, this technology is the most advanced to create immersion and sense of presence in a virtual environment (VE) and gives the opportunity to study cognitive mechanisms in more ecological way. However, little is known about the impact of VR on the cognition and emotional states of the VR users. According to the scientific literature, the sense of presence (the fact that the user experiences the sense of being in the VE) is strongly related to the emotional experience, but it is not clear what mechanisms underline this relation. Thus, more research is necessary to its better understanding. Moreover, a few studies have shown age related differences in sense of presence, with children having greater inclination for sense of presence than adults. This might be explained by the fact that frontal cortex (which is responsible for a control of the sense of presence) is still developing in childhood (the maturation last for the beginning of adulthood). The goal of the present study is to examine which factors might be responsible of the interaction between the sense of presence, the immersion and the emotional experience in Virtual Reality, and the age-related difference. Thus, the investigator study 2 types of healthy participants (volunteers) in order to examine the age-related difference in this interaction: young adults between 18 and 25 years old and children between 8 to 14 years old. To study different factors potentially involved in the interaction four experiments will be conducted. In each experiment the investigator manipulate one type of factor to study its impact on emotions and the sense of presence in a VE: (1) the image quality, (2) the fact that participant had an avatar (body) in the VE, (3) the possibility to interact or not in VE and (4) the nature of elements with which it is possible to interact (objects or living being). In the end of this study the investigator hope to contribute to the knowledge of adapted use of VR for different type of users, such as children and young adults.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 5, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

January 25, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2020

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

Enrollment Period

1.1 years

First QC Date

June 22, 2018

Last Update Submit

October 25, 2021

Conditions

Keywords

FeelingsEmotionsVirtual RealityYoung AdultChild

Outcome Measures

Primary Outcomes (6)

  • measure of valence and arousal with Self-Assessment Manikin (SAM) scale

    Evaluation of emotion

    Day 0

  • response to the presence questionnaire (PQ, Witmer & Singer, 1998

    Evaluation of feeling of presence questionnaire PQ, Witmer \& Singer, 1998

    Day 0

  • evaluation of feeling of immersion by a Likert scale

    Evaluation of feeling of immersion

    Day 0

  • responses evoked by the stimuli of interest

    During Experience in Virtual Reality (EVR) we will measure responses evoked by the stimuli of interest: with oculometer time fixation and pupillary dilatation, and with oximeter heart rate

    Day 0

  • Measure of evoked potential

    During EVR only in Experiment 1B we will measure, using EEG, evoked potential, particularly Late Positive Potential (LPP)

    Day 0

  • Measure of head movements evoked by the stimuli of interest

    During EVR except Experiment 1B we will measure, using the device integrated in VR equipment, head movements evoked by the stimuli of interest

    Day 0

Study Arms (4)

Experiment 1 A, B - Level of realism of EVR

EXPERIMENTAL

Participants (50 children and 50 young adults for part A, and 50 other children and 50 other young adults) will be exposed to virtual experience having different level of realism. In one condition the realism will be high (very close to the real word) and in the second condition the realism will be low (comparable to cartoon). The stimuli of interest included in virtual experience will be of three emotional categories : negative, positive and neutral.

Behavioral: manipulation of the level of realism

Experiment 2 - Presence and size of avatar

EXPERIMENTAL

Participants (50 children and 100 young adults) will be exposed to virtual experiences in which in one condition they will be part of the virtual environment in a body of an avatar and in another condition the avatar will not be present. Children will be exposed to only one of the two possible situations: with an avatar or without an avatar for the entire experience. Adults will be exposed to only one of the four possible situations: with standard size avatar, with giant avatar, with tiny avatar, or without avatar.

Behavioral: manipulation of the presence and size of avatar

Experiment 3 - Interaction in virtual experience

EXPERIMENTAL

Participants (50 children and 50 young adults) will be submitted to two conditions of virtual experience, one condition in which it is possible to interact with the stimuli presented in the virtual environment and another condition in which it is not possible to interact. In addition, the stimuli of interest will be of one of three emotional categories : negative, positive and neutral. Thus participants will be exposed to six short virtual experiences.

Behavioral: manipulation of interaction

Experiment 4 - Animate/Inanimate nature of interactive objects

EXPERIMENTAL

Participants (30 children and 30 young adults) will be exposed to the virtual experience during which they will be able to interact in one condition with animated (e.g., dog, bird) stimuli and in another condition with inanimate (e.g., book, jacket) stimuli. The animate and inanimate stimuli of interest will be of three emotional categories : negative, positive and neutral.

Behavioral: manipulation of the nature of stimulus

Interventions

The realism of the virtual experience will be manipulated. In one condition the realism will be high and in another condition the realism will be low. In addition, emotional category of stimuli for each virtual experience condition will be manipulated. Thus, each participant will be submitted to six virtual experiences (e.g., high realism with negative stimuli, low realism with negative stimuli, high realism with positive stimuli). The measures of the pupillary responses, gaze fixation, heart rate, head movement (only in part A) and Late Positive Potential (EEG - only in part B) will be realized. In addition, the participants will respond to the scales and questionnaire evaluating their emotion, feeling of presence and feeling of immersion.

Experiment 1 A, B - Level of realism of EVR

The presence of avatar in the virtual experience will be manipulated. In one condition the avatar will be present and in another condition the avatar will not be present. In addition, emotional category of stimuli for each virtual experience condition will be manipulated. Thus, each participant will be submitted to six virtual experiences (e.g., with avatar and negative stimuli, without avatar and negative stimuli, with avatar and positive stimuli, etc.). Children will be exposed to only one of the two possible situations: with an avatar or without an avatar for the entire experience. Adults will be exposed to only one of the four possible situations: with standard size avatar, with giant avatar, with tiny avatar, or without avatar. The measures of the pupillary responses, gaze fixation, heart rate, head movement will be realized. In addition, the participants will respond to the scales and questionnaire evaluating their emotion, feeling of presence and feeling of immersion.

Experiment 2 - Presence and size of avatar

Virtual experience condition will be manipulated. In one condition the participants will be exposed to the virtual experience in which they will be able to interact with some of the stimuli, in another condition they will not be able to interact with the stimuli (passive watching). In addition, emotional category of stimuli for each virtual experience condition will be manipulated. Thus, each participant will be submitted to six virtual experiences (e.g., interaction possible - negative stimuli, interaction impossible - negative stimuli, interaction possible - positive stimuli). The measures of the pupillary responses, gaze fixation, heart rate, head movement will be realized. In addition, the participants will respond to the scales and questionnaire evaluating their emotion, feeling of presence and feeling of immersion.

Experiment 3 - Interaction in virtual experience

The nature of the stimuli with which the participants will interact will be manipulated. During virtual experience the participants will have a choice to interact or not with the virtual environment, in one condition with animate stimuli and in another condition with inanimate stimuli. In addition, emotional category of animate and inanimate stimuli will be manipulated. Thus, each participant will be submitted to six virtual experiences (e.g., condition with animate negative stimuli, condition with inanimate negative stimuli, condition with animate positive stimuli). The measures of the pupillary responses, gaze fixation, heart rate, head movement will be realized. In addition, the participants will respond to the scales and questionnaire evaluating their emotion, feeling of presence and feeling of immersion.

Experiment 4 - Animate/Inanimate nature of interactive objects

Eligibility Criteria

Age8 Years - 28 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children:
  • Age comprised between 8 and 14
  • Native French speaker
  • Two parents gave their informed consent for a participation of their child in the study
  • Young adults :
  • Students
  • Age comprised between 18 and 25
  • Native French speaker
  • Participant gave his/her informed consent for a participation in the study
  • Participant has health insurance

You may not qualify if:

  • Children:
  • Neurodevelopmental deficits, diagnosis of intellectual deficiency (Scores below 70 for Vineland II scale et Total IQ Total below 70 for WPPSI-IV (Wechsler, 2014) or WISC-V (Wechsler, 2016)) new by parents or legal representative
  • Learning disorder (difficulties in learning and using scholar skills since at least 6 months new by teacher, parents or legal representative)
  • History of psychiatric disorder new by parents or legal representative
  • Neurological disorders new by parents or legal representative
  • Drugs intake having impact on motor, cognitive or memory capacities (e.g., corticoids) new by parents or legal representative
  • Visual or hearing disorders without correction
  • Epilepsy
  • Child, parents or legal representative no agreement to participate to the study
  • Young Adults :
  • Neurological disorders new by participants
  • Drugs intake having impact on motor, cognitive or memory capacities (e.g., corticoids)
  • History of psychiatric disorder new by participant
  • Use of drugs of alcohol
  • Visual or hearing disorders without correction
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EA3082 Laboratoire d'Etude des Mécanismes Cognitifs Institut de Psychologie Université Lyon 2

Bron, France

Location

Study Officials

  • Hanna CHAINAY

    Université Lyon 2

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2018

First Posted

July 5, 2018

Study Start

January 25, 2019

Primary Completion

March 3, 2020

Study Completion

March 3, 2020

Last Updated

November 1, 2021

Record last verified: 2021-10

Locations