NCT03920592

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

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

April 9, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

April 10, 2019

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 19, 2019

Completed
Last Updated

April 29, 2019

Status Verified

April 1, 2019

Enrollment Period

2 days

First QC Date

April 9, 2019

Last Update Submit

April 26, 2019

Conditions

Keywords

Virtual realityPsychophysiologyEmpathy

Outcome Measures

Primary Outcomes (3)

  • Self-assessment manikin (SAM)

    Arousal and valence (5-point graphic scale)

    Baseline

  • Heart rate (HR) and heart rate variability (HRV)

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

    Baseline

  • Electrodermal activity (EDA)

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

    Baseline

Secondary Outcomes (4)

  • The Inventory of Callous-Unemotional Traits (ICU) in Children

    Baseline

  • Empathy toward victim

    Baseline

  • Ad-hoc items regarding bullying

    Baseline

  • Ad-hoc item on "presence"

    Baseline

Study Arms (1)

Video watching

EXPERIMENTAL

All 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.

Behavioral: Virtual Reality of Bullying

Interventions

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

Video watching

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Corporació Sanitària Parc Taulí

Sabadell, 08208, Spain

Location

Related Publications (4)

  • 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.

    BACKGROUND
  • 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.

    PMID: 27909830BACKGROUND
  • 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.

    PMID: 19083379BACKGROUND
  • 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.

    PMID: 20886285BACKGROUND

Study Officials

  • Narcís Cardoner, MD, PhD

    Corporacion Parc Tauli

    PRINCIPAL INVESTIGATOR
  • Miguel Barreda, PhD

    Eurecat, Centre Tecnològic de Catalunya

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Participants are unaware of which condition is being tested
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Psychiatrist, Director Depression and Anxiety Program & OSAMCAT

Study Record Dates

First Submitted

April 9, 2019

First Posted

April 19, 2019

Study Start

April 10, 2019

Primary Completion

April 12, 2019

Study Completion

April 12, 2019

Last Updated

April 29, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations