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临床试验/NCT07148219
NCT07148219尚未招募不适用

Embrace Your Power: A VR Journey to Overcoming Negative Emotions for Romanian Youth

University of Bucharest1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
300
试验地点
1
主要终点
Bullying behaviors

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
10 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Bullying behaviors

时间窗: Pre-intervention (baseline), middle intervention, post-intervention (week 7)

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).

次要结局

  • Emotional symptoms(Pre-intervention (baseline), middle intervention, post-intervention (week 7))

研究者

发起方
University of Bucharest
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cezar Giosan

Cezar Giosan, PhD

University of Bucharest

研究点 (1)

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