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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03577288
Other study ID # 69HCL18_0224
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date January 25, 2019
Est. completion date March 3, 2020

Study information

Verified date October 2021
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 240
Est. completion date March 3, 2020
Est. primary completion date March 3, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 28 Years
Eligibility Inclusion Criteria: 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 Exclusion Criteria: 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 - Epilepsy - No agreement to participate to the study

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
manipulation of the level of realism
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.
manipulation of the presence and size of avatar
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.
manipulation of interaction
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.
manipulation of the nature of stimulus
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.

Locations

Country Name City State
France EA3082 Laboratoire d'Etude des Mécanismes Cognitifs Institut de Psychologie Université Lyon 2 Bron

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary measure of valence and arousal with Self-Assessment Manikin (SAM) scale Evaluation of emotion Day 0
Primary response to the presence questionnaire (PQ, Witmer & Singer, 1998 Evaluation of feeling of presence questionnaire PQ, Witmer & Singer, 1998 Day 0
Primary evaluation of feeling of immersion by a Likert scale Evaluation of feeling of immersion Day 0
Primary 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
Primary Measure of evoked potential During EVR only in Experiment 1B we will measure, using EEG, evoked potential, particularly Late Positive Potential (LPP) Day 0
Primary 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
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