EMBRACE YOUR POWER

NCT ID: NCT07148219

Last Updated: 2025-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2027-01-31

Brief Summary

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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.

Detailed Description

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This protocol outlines a cluster, parallel-group, exploratory, randomized controlled trial where participants are randomly allocated to one of the two groups: intervention or control.

* The main objective is to implement and assess the effectiveness of the program for combating bullying through virtual reality. The program aims to reduce victimization and bullying behaviors (physical, verbal, and relational aggression) by applying the APRI tool as a result of participating in VR scenarios that simulate these situations and to reduce emotional difficulties and behavioral problems, as well as increase prosocial behavior.
* The included classes will serve as the randomization units. Students aged between 10 and 14 years, (5th and 6th grades from middle schools) will participate in the study. The intervention will last 7 weeks, and the two groups will be assessed at (1) pre-intervention (baseline), (2) middle of the intervention (week 3 or 4), and (3) post-intervention. The data analysis will focus on improvement in outcomes between and within groups.

Conditions

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Bullying Distress Bullying Victimisation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention

VR program for preventing and combating bullying

Group Type EXPERIMENTAL

Embrace Your Power: A VR Journey to Overcome Negative Emotions

Intervention Type BEHAVIORAL

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.

Waitlist

The control group receives the intervention after the study ends.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Embrace Your Power: A VR Journey to Overcome Negative Emotions

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 Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Medical problems that have VR-based procedures as contraindicated because they can induce dizziness, seizures, nausea:

1. epilepsy
2. presence of seizures
3. severe motion sickness- vestibular disorders
4. significant vision problems that would interfere with the use of the headset
5. severe migraines triggered by exposure to screens
* Neurodevelopmental disorders

1. Autism spectrum disorder- level 3 of severity or sensory processing disorders
2. 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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Remnant Dream SRL

UNKNOWN

Sponsor Role collaborator

University of Bucharest

OTHER

Sponsor Role lead

Responsible Party

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Cezar Giosan

Cezar Giosan, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Bucharest

Bucharest, , Romania

Site Status

Countries

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Romania

Central Contacts

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Cezar Giosan, PhD

Role: CONTACT

+40730908050

Other Identifiers

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09242025

Identifier Type: -

Identifier Source: org_study_id

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