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Bullying of ChildNCT03920592

Virtual Reality and Prevention of Bullying

A study testing Virtual Reality of Bullying in people with Bullying of Child, run by Narcis Cardoner, MD, PhD at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The lack of empathy towards victims of bullying is thought to play a main role in this extended and pernicious peer victimization behaviour. Thus, promoting empathy in school programs might be a promising approach for bullying prevention. Read more about this study

Who is it for?
Ages 9 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Bullying of Child
What is being tested?
Virtual Reality of Bullying
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteSpain
Study dates
10 Apr 2019to 12 Apr 2019
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 9 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • All pupils assisting 5th and 6th grade of primary school (Spain education system) of the "Escola Parc del Guinardó" school
  • Pupils whos parents have read, understand and approved the informed consent of the study.

Who cannot join

  • Pupils whose parents have not approved their inclusion in the study.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Corporació Sanitària Parc Taulí

    Sabadell, 08208

Other trials in Spain

About this study

Official title: Effect of Bullying Content Presented in Immersive 360º-video on Pupil's Cognitive and Psychophysiological Responses

The lack of empathy towards victims of bullying is thought to play a main role in this extended and pernicious peer victimization behaviour. Thus, promoting empathy in school programs might be a promising approach for bullying prevention. Virtual reality (VR) allows creating an environment very similar to the real world and has proved to promote empathy.

Therefore, by employing VR, pupils may better understand and feel the experience of being bullied. As there is no evidence of the efficiency of VR in bullying prevention, the first step is to validate the content of the environments created.

In this line, the current study aims to investigate if 360º-videos produce a truthful experience of being bullied superior than the observed in traditional computer screens. The effect of all, 360º-videos and 2D computer screens will be assessed through objective (electrodermal activity -EDA- and heart rate -HR-) and subjective (self-administered tests) measures.

Read the detailed description

Introduction and Rationale: Previous research suggests that working on the development of cognitive-emotional skills, and particularly on empathy toward victims of bullying, may be a central component for the success of school bullying prevention programs. On the other hand, virtual reality (VR) technology allows adopting the perspective of the world of others, and thus has been claimed to be a powerful tool for eliciting empathy in different domains (cf. Slater \& Sánchez-Vives, 2016). Therefore, VR might play a role in bullying prevention programs, by helping pupils to understand how it feels to be bullied, as a way to increase empathy towards victims of bullying. However, currently empirical evidence of the effectiveness of VR in this context is lacking. A key step in the validation of this use of VR is to understand how the immersive presentation of bullying scenes shot from a first-person perspective is experienced by children, compared to the same scenes presented in less immersive displays. In particular, in order to demonstrate the potential of VR technology in this regard, it is necessary to examine the advantages that VR technology (and, more specifically in this case, immersive presentation of 360º-video) presents over more common devices (a computer screen).

Study goals and Hypotheses: The overall goal of this study is to examine whether 360º-videos representing situations of bullying from a first-person perspective produce a realistic experience of being bullied, and that the presentation of such contents in an immersive mode (using a VR headset) elicit a more realistic and arousing experience than the same contents in a less immersive format (a traditional computer screen).

This is the first step in a wider research project; in subsequent steps, the investigators will assess the effects of these type of videos on empathy towards victims of bullying and, eventually, on prevalence of bullying behaviour.

The central hypotheses to be tested will be:

Hypothesis 1 (H1): Contents representing situations of bullying from a first person perspective will elicit on participants realistic feelings of being bullied, compared to contents representing other high-school daily situations not involving (physical or verbal) violence.

Hypothesis 2 (H2): Immersive presentation (i.e. 360º-video contents watched in a VR headset) will elicit higher arousal and higher perceived realism of the scene than the same contents presented in a less immersive display (a computer screen).

In order to test these hypotheses, the investigators will collect measures of psychophysiological measures of arousal (electrodermal activity -EDA- and heart rate -HR-) and emotional regulation (heart rate variability -HRV-), self-reported emotional arousal and valence, as well as three self-reported measures of the realism of the experience of being bullied, including: (1) participant's perception on to which degree the represented situation can be considered bullying, (2) participant's feelings of actually being in the represented scene ("presence"), and (3) participant's feeling of actually being bullied while watching the content.

The investigators expect that, compared to watching videos representing other high-school daily situations not involving (physical or verbal) violence, watching videos representing situations of bullying, participants' EDA, HR, HRV, and self-reported arousal will be higher (H1a, H1b, H1c, and H1d, respectively), self-reported valence will be more negative (H1e), scores of feelings of being bullying and actually being in the scene will be higher (H1f and H1g, respectively), and the perception of the scene as bullying will also be enhanced (H1h).

It is also expected that, compared to the videos presented in a screen, while watching the videos in a VR headset participants' EDA, HR, HRV, and self-reported arousal will be higher (H2a, H2b, H2c, and H2d, respectively), self-reported valence will be more negative (H2e), scores of feelings of being bullying and actually being in the scene will be higher (H2f and H2g, respectively), and the perception of the scene as bullying will also be enhanced (H2h).

In addition, it will be explored whether the experienced arousal and perception of realism is associated with personality traits, such as being uncaring, unemotional, and callousness. The investigators believe that pupils with higher scores on the mentioned traits will experience less arousal (subjective and psychophysiological) when watching the videos with bullying content.

Experimental design: The study adopts a within-subject design in which each participant will watch four videos, containing the four possible combinations of two independent variables: Level of immersion (VR headset / computer screen) and Type of content (Bullying / no-bullying content).

The materials to be used in the experiment will be eight videos representing different scenes from the perspective of a girl (to be watched by female participants) and four videos representing different scenes from the perspective of a boy (to be watched by male participants). Among each group of eight videos, there are four pairs. The two videos of each pair involve the same location, point-of-view, and actors, but in one of them there is a bullying situation and in the other there is a daily situation not involving any form of violence (e.g. children chatting about the last weekend).

Each participant will watch four scenes, two containing bullying scenes and the other containing daily non-violent scenes. Also, two of them will be presented in a VR headset while the rest be presented in a computer screen. The level of immersion and type of content in which each scene is presented will vary among participants following a Latin-square design, in a way such for the whole sample of participants, all the scenes will be presented across the two levels of immersion and the two types of content. The order of the presentation of the four conditions will be randomised for each participant.

Being tested
Virtual Reality of Bullying
Keywords
Virtual reality, Psychophysiology, Empathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Reality of BullyingBehavioural

    Immersive videos (360º) filmed by 12-14 year old pupils who, guided by professional actors, represented the subjective experience of bullying.

    Eight different potential situations designed depending on the sex of the pupil were filmed:

    Girls:

    1. Classmates steal her personal diary
    2. Classmates tear her clothing
    3. Classmates insult her and steal her belongings
    4. Classmates deliberately exclude her in class

    Boys:

    1. Classmates exclude him while playing with a ball
    2. Classmates bother him in the dining room
    3. Classmates insult and steal him in class
    4. Classmates insult him and steal his belongings
Study groups in NCT03920592
Study groupRoleWhat they receive
Video watchingExperimentalAll participants will watch 4 videos of potential everyday school situations, adapted for boys and girls. Videos contain different levels of bullying (presence/absence) and virtual reality (presence/absence). Every pupil will watch the 4 types of video content randomly.
Receives: Behavioral: Virtual Reality of Bullying

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Self-assessment manikin (SAM)

    Arousal and valence (5-point graphic scale)

    Measured: Baseline

  2. Heart rate (HR) and heart rate variability (HRV)

    An electrocardiogram will be recorded as an indirect indicator of the physiological arousal.

    Measured: Baseline

  3. Electrodermal activity (EDA)

    The skin conductance will be registered as an indirect indicator of the physiological arousal. Tonic and phasic measures will be registered.

    Measured: Baseline

Secondary outcomes (4)
  1. The Inventory of Callous-Unemotional Traits (ICU) in Children

    The self-report version of the ICU assesses uncaring, unemotional, and callousness traits.

    Te scale has 24-items, ranked on a 4-point Likert scale, from 0 (not at all true) to 3 (definitely true). Possible scores ranges from 0-72, where higher scores indicate greater presence of the construct.

    Measured: Baseline

  2. Empathy toward victim

    7-item scale to assess empathy towards bullying. Higher scores indicate greater presence of the construct.

    Measured: Baseline

  3. Ad-hoc items regarding bullying

    Two ad-hoc items on how much the video presents a situation of "bullying", and to which extent the participant feel "been bullied" while watching the video. 5-point Likert scale in which 0 means "none" and 5 "absolutely". The items were:

    1. I think the video represents a situation of harassment
    2. I have really felt harassed while looking at the video

    Measured: Baseline

  4. Ad-hoc item on "presence"

    Feeling of being involved in the virtual environment. 5-point Likert scale in which 0 means "none" and 5 "absolutely". The item was:

    1. I felt that I was "there" in the video scene

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2019
  2. Study start10 Apr 2019
  3. Primary completion12 Apr 2019
  4. Study completion12 Apr 2019

Resources

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
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
Each participant, depending on their sex, watch two minutes of each video content: 1. Bullying content in virtual reality 2. Bullying content in a regular 2D screen 3. Pupils playing without bullying content in virtual reality 4. Pupils playing without bullying content in a regular 2D screen
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03920592
Sponsor's protocol ID
CSMPT_NC_2019_1
Status last verified
Apr 2019
First submitted
9 Apr 2019
Last updated
29 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fanti, K. A., & Kimonis, E. R. (2012). Bullying and Victimization: The Role of Conduct Problems and Psychopathic Traits. Journal of Research on Adolescence, 22(4), 617-631.

  • Moore AA, Carney D, Moroney E, Machlin L, Towbin KE, Brotman MA, Pine DS, Leibenluft E, Roberson-Nay R, Hettema JM. The Inventory of Callous-Unemotional Traits (ICU) in Children: Reliability and Heritability. Behav Genet. 2017 Mar;47(2):141-151. doi: 10.1007/s10519-016-9831-1. Epub 2016 Dec 1.

    PubMed 27909830
  • Nickerson AB, Mele D, Princiotta D. Attachment and empathy as predictors of roles as defenders or outsiders in bullying interactions. J Sch Psychol. 2008 Dec;46(6):687-703. doi: 10.1016/j.jsp.2008.06.002. Epub 2008 Jul 15.

    PubMed 19083379
  • Munoz LC, Qualter P, Padgett G. Empathy and bullying: exploring the influence of callous-unemotional traits. Child Psychiatry Hum Dev. 2011 Apr;42(2):183-96. doi: 10.1007/s10578-010-0206-1.

    PubMed 20886285

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality of Bullying in people with Bullying of Child, run by Narcis Cardoner, MD, PhD at 1 site in Spain.

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 2 inclusion and 1 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: finished, as of the sponsor's last update on 29 Apr 2019. 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 Spain. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Self-assessment manikin (SAM) (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03920592, which also lists 4 linked publications.

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 29 Apr 2019.

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