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Набор скоро начнётся NCT07148219

EMBRACE YOUR POWER

Без фазы С лечением Bullying Distress Bullying Victimisation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Embrace Your Power: A VR Journey to Overcome Negative Emotions.
Кому может быть актуально
Состояния в реестре: Bullying, Distress, Bullying Victimisation. Базовые параметры: 10 лет — 14 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Румыния
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое 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 con

Первичные конечные точки

  • Bullying behaviors [Срок оценки: Pre-intervention (baseline), middle intervention, post-intervention (week 7)]
Вторичные конечные точки (1)
  • Emotional symptoms [Срок оценки: Pre-intervention (baseline), middle intervention, post-intervention (week 7)]

Критерии участия

Критерии включения

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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

Румыния · 1 центр
  • University of Bucharest — Bucharest

Идентификаторы

NCT: NCT07148219 · 09242025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗