NCT07148219

Brief Summary

The goal of this randomized controlled trial is to test the effectiveness of an educational tool, based on virtual reality (VR), for preventing and combating bullying and for improving the emotional well-being of pre-adolescent students. Participants will be allocated to one of two conditions:

  • (1) intervention group: Embrace your power intervention for combating bullying;
  • (2) waitlist (inactive control): the control group receives intervention after the study ends. The intervention group will be compared to the control group in terms of peer aggression and victimization (bullying behaviors) and emotional symptoms.

Trial Health

63
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Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress48%
Oct 2025Jan 2027

First Submitted

Initial submission to the registry

August 22, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 29, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

12 months

First QC Date

August 22, 2025

Last Update Submit

August 22, 2025

Conditions

Keywords

randomized controlled trialbullyingvirtual realitydistress

Outcome Measures

Primary Outcomes (1)

  • Bullying behaviors

    Bullying behaviors will be measured using the Adolescent Peer Relations Instrument (APRI) -C2. The instrument encompasses bullying victimization, perpetration, and bystander experiences. APRI represents a psychometric tool that measures teens' experiences with bullying and victimization through 36 items rated on a 6-point Likert scale (1= never, 6= every day).

    Pre-intervention (baseline), middle intervention, post-intervention (week 7)

Secondary Outcomes (1)

  • Emotional symptoms

    Pre-intervention (baseline), middle intervention, post-intervention (week 7)

Other Outcomes (1)

  • Strengths and Difficulties

    Pre-intervention (baseline), middle intervention, post-intervention (week 7)

Study Arms (2)

Intervention

EXPERIMENTAL

VR program for preventing and combating bullying

Behavioral: Embrace Your Power: A VR Journey to Overcome Negative Emotions

Waitlist

NO INTERVENTION

The control group receives the intervention after the study ends.

Interventions

EYP-VR represents a virtual reality (VR) educational tool to combat bullying. Using Meta Quest 3 passthrough technology, the app combines real-world classroom elements with immersive virtual scenarios, enabling safe and interactive experiences that simulate bullying situations but that do not place students in the roles of victims or aggressors but heroes or protectors. The app guides participants through narrative episodes focused on building empathy, practicing assertiveness, and learning conflict resolution techniques. AI-driven characters dynamically respond to students' actions as they engage in puzzles, and sensory feedback (visual, auditory, and haptic) reinforces key socio-emotional learning outcomes. The program will take place in classrooms during instructional hours. Each session will end with a feedback phase so that the school counselor can manage any issues that interest them.

Intervention

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Students 5th and 6th grade
  • Students whose parents have given their consent and who have also agreed to participate in the program

You may not qualify if:

  • Medical problems that have VR-based procedures as contraindicated because they can induce dizziness, seizures, nausea:
  • epilepsy
  • presence of seizures
  • severe motion sickness- vestibular disorders
  • significant vision problems that would interfere with the use of the headset
  • severe migraines triggered by exposure to screens
  • Neurodevelopmental disorders
  • Autism spectrum disorder- level 3 of severity or sensory processing disorders
  • ADHD, if hyperactivity would prevent the student from staying in the exercise for longer
  • Severe mental disorders: psychotic spectrum disorders, post-traumatic stress disorder, present suicidal ideation
  • If children have an extremely low level of literacy perceived by the teacher and counselor, and this aspect would prevent them from participating in the program.
  • Parallel participation in other bullying prevention programs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bucharest

Bucharest, Romania

Location

MeSH Terms

Conditions

Bullying

Condition Hierarchy (Ancestors)

AggressionBehavioral SymptomsBehaviorHarassment, Non-SexualSocial Behavior

Central Study Contacts

Cezar Giosan, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A randomized controlled trial where participants are divided into 2 groups: the intervention group that has access to the virtual reality program for preventing bullying and the inactive control group that receives the intervention after the study ends.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cezar Giosan, PhD

Study Record Dates

First Submitted

August 22, 2025

First Posted

August 29, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

August 29, 2025

Record last verified: 2025-08

Locations