Status:
NOT_YET_RECRUITING
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Lead Sponsor:
University of Bucharest
Collaborating Sponsors:
Remnant Dream SRL
Conditions:
Bullying
Distress
Eligibility:
All Genders
10-14 years
Phase:
NA
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 w...
Detailed Description
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 obje...
Eligibility Criteria
Inclusion
- Students 5th and 6th grade
- Students whose parents have given their consent and who have also agreed to participate in the program
Exclusion
- 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
- Points a) and b) do not represent automatic exclusion criteria, because depending on the judgment of the school counselor, the parent and the teacher, it is possible that a participant will be able to complete the program.
- 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.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT07148219
Start Date
October 1 2025
End Date
January 1 2027
Last Update
August 29 2025
Active Locations (1)
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1
University of Bucharest
Bucharest, Romania