Healthy VolunteersEPREV-EANCT03577288
Impact of Emotion in Virtual Reality on Behavior of Children and Young Adults
A study testing manipulation of the level of realism, manipulation of the presence and size of avatar and manipulation of interaction in people with Healthy Volunteers, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 8 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- manipulation of the level of realism, manipulation of the presence and size of avatar and manipulation of interaction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jan 2019to 3 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 28 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
EA3082 Laboratoire d'Etude des Mécanismes Cognitifs Institut de Psychologie Université Lyon 2
Bron
About this study
Official title: Impact of Appearance and Control of Emotions in Virtual Reality on Behaviour in Children and Young Adults: Link With Feeling of Presence
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.
- Conditions
- Healthy Volunteers
- Being tested
- manipulation of the level of realism, manipulation of the presence and size of avatar, manipulation of interaction, manipulation of the nature of stimulus
- Keywords
- Feelings, Emotions, Virtual Reality, Young Adult, Child
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manipulation of the level of realismBehavioural
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 avatarBehavioural
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 interactionBehavioural
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 stimulusBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: manipulation of the nature of stimulus |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure of valence and arousal with Self-Assessment Manikin (SAM) scale
Evaluation of emotion
Measured: Day 0
response to the presence questionnaire (PQ, Witmer & Singer, 1998
Evaluation of feeling of presence questionnaire PQ, Witmer \& Singer, 1998
Measured: Day 0
evaluation of feeling of immersion by a Likert scale
Evaluation of feeling of immersion
Measured: 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
Measured: Day 0
Measure of evoked potential
During EVR only in Experiment 1B we will measure, using EEG, evoked potential, particularly Late Positive Potential (LPP)
Measured: 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
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start25 Jan 2019
- Primary completion3 Mar 2020
- Study completion3 Mar 2020
Why it stopped: Study had to be stopped in 2020 with the health crisis linked to COVID-19. Following this, and in view of the sanitary conditions, it was not possible to resume recruitment (research was taking place within the University of Lyon 2 and in schools)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hanna CHAINAY, Principal investigator, Université Lyon 2
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577288
- Sponsor's protocol ID
- 69HCL18_0224
- Acronym
- EPREV-EA
- Status last verified
- Oct 2021
- First submitted
- 22 Jun 2018
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Appearance and Control of Emotions in Virtual Reality on Behaviour in Children and Young Adults: Link With Feeling of Presence
- ClinicalTrials.gov ID
- NCT03577288
- Acronym / sponsor ID
- EPREV-EA / 69HCL18_0224
- Conditions
- Healthy Volunteers
- Keywords
- Feelings, Emotions, Virtual Reality, Young Adult, Child
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study had to be stopped in 2020 with the health crisis linked to COVID-19. Following this, and in view of the sanitary conditions, it was not possible to resume recruitment (research was taking place within the University of Lyon 2 and in schools)
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 3 Mar 2020 (actual)
- Study completion
- 3 Mar 2020 (actual)
- First posted
- 5 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experiment 1 A, B - Level of realism of EVR | Experimental | Behavioral: manipulation of the level of realismParticipants (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. |
| Experiment 2 - Presence and size of avatar | Experimental | Behavioral: manipulation of the presence and size of avatarParticipants (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. |
| Experiment 3 - Interaction in virtual experience | Experimental | Behavioral: manipulation of interactionParticipants (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. |
| Experiment 4 - Animate/Inanimate nature of interactive objects | Experimental | Behavioral: manipulation of the nature of stimulusParticipants (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. |
Who may qualify
- Ages
- 8 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Age comprised between 8 and 14
- Native French speaker
- Two parents gave their informed consent for a participation of their child in the study
- Students
- Age comprised between 18 and 25
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| manipulation of the level of realismThe 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. | Behavioural | Experiment 1 A, B - Level of realism of EVR |
| manipulation of the presence and size of avatarThe 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. | Behavioural | Experiment 2 - Presence and size of avatar |
| manipulation of interactionVirtual 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. | Behavioural | Experiment 3 - Interaction in virtual experience |
| manipulation of the nature of stimulusThe 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. | Behavioural | Experiment 4 - Animate/Inanimate nature of interactive objects |
Primary outcome
measure of valence and arousal with Self-Assessment Manikin (SAM) scale
Time frame: Day 0
Evaluation of emotion
response to the presence questionnaire (PQ, Witmer & Singer, 1998
Time frame: Day 0
Evaluation of feeling of presence questionnaire PQ, Witmer \& Singer, 1998
evaluation of feeling of immersion by a Likert scale
Time frame: Day 0
Evaluation of feeling of immersion
responses evoked by the stimuli of interest
Time frame: Day 0
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
Measure of evoked potential
Time frame: Day 0
During EVR only in Experiment 1B we will measure, using EEG, evoked potential, particularly Late Positive Potential (LPP)
Measure of head movements evoked by the stimuli of interest
Time frame: Day 0
During EVR except Experiment 1B we will measure, using the device integrated in VR equipment, head movements evoked by the stimuli of interest
Results and safety
The study was stopped early (reason given: Study had to be stopped in 2020 with the health crisis linked to COVID-19. Following this, and in view of the sanitary conditions, it was not possible to resume recruitment (research was taking place within the University of Lyon 2 and in schools)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanna CHAINAY principal investigator
Université Lyon 2
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing manipulation of the level of realism, manipulation of the presence and size of avatar and manipulation of interaction in people with Healthy Volunteers, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study had to be stopped in 2020 with the health crisis linked to COVID-19. Following this, and in view of the sanitary conditions, it was not possible to resume recruitment (research was taking place within the University of Lyon 2 and in schools)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure of valence and arousal with Self-Assessment Manikin (SAM) scale (time frame: Day 0). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.