跳至主要内容
临床试验/NCT07168759
NCT07168759Enrolling By Invitation不适用

An Educational Intervention Using a Virtual Reality Game to Improve Compliance With Coronavirus 2019 Disease-related Hygiene Practices and Participation in Severe Acute Respiratory Syndrome Virus 2 (SARS-CoV-2) Screening, for the Prevention of SARS-CoV-2 Transmission Between Primary Schoolchildren in Communities: a Stratified Cluster-randomised Controlled Trial

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 2,160 人开始时间: 2023年5月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
2,160
试验地点
1
主要终点
Change from baseline in the compliance with hygiene practices immediately after intervention

研究概览

简要总结

The goal of this observational study is to investigate if VR game-based educational intervention can enhance primary schoolchildren's compliance with hygiene practices to prevent the transmission of SARS-CoV-2 and other upper respiratory pathogens in the community.

The main questions the study aims to answer are, after receiving the VR game-based education intervention:

  • Does VR game-based educational intervention improve hygiene-practice compliance in primary schoolchildren?
  • What are the bacterial loads on primary schoolchildren's hands?
  • What are the rates of infections caused by SARS-CoV-2 and other respiratory viruses in primary schoolchildren?

Researchers will compare the interventional group to the control group to see if VR game-based educational intervention can enhance primary schoolchildren's hygiene practices.

Participants will

  • Receive in a training programme on hygiene practices through playing VR games for two weeks, 1 hour per week.
  • Do a questionnaire on hygiene knowledge before and after receiving the education programme
  • Provide hand swabs and saliva samples before and after receiving the education programme

详细描述

This study aims to evaluate the effectiveness of a VR game (VRG)-based educational program on hygiene practices among primary schoolchildren in Hong Kong. The research design employs a randomized controlled trial with repeated measures.

Participants will be primary schoolchildren aged 6 to 12 who can communicate and read in Chinese. To minimize selection bias, children will remain unaware of their group assignments. The sample size calculation aims for a statistical power of at least 0.8, targeting 2160 participants across 18 school clusters. Thirty-six local primary schools will be randomly assign to the intervention group or the control group in a ratio of 1:1.

The pilot phase will refine the VRG educational program based on feedback from a previous intervention. Two schools will be selected for this pilot, where trained teachers will assist in student recruitment. The main intervention will involve an VRG-based educational program delivered over two to three weeks. Children in the intervention group will engage with VRGs that cover topics such as SARS-CoV-2 and influenza virus transmission, hygiene practices, importance of rapid testing and vaccination in the prevention of upper respiratory tract infections. The control group will receive standard community health education and will be invited to participate in the VRG program after the intervention period.

Each child's involvement will last six months, with assessments occurring at baseline (T1) and at two subsequent intervals: immediately-post (T2), 1-month post (T3). Data collection will include demographic data, questionnaire to assesses hygiene knowledge, videos to record handwashing practices, hand swabs to measures bacterial loads on hands and saliva samples to tests for respiratory viruses.

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 (Participant)

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Primary schoolchildren aged 6-12 years.
  • •Able to communicate in Chinese and to read Chinese.

排除标准

  • •Reported mental or physical health disorders.
  • •Participated in other health educational programs related to hygiene practices 2 months or less before recruitment.

研究组 & 干预措施

Intervention group

Experimental

School children will participate in a VR game-based education programme

干预措施: VR game -based education program (Other)

Control group

No Intervention

Schoolchildren in this group will receive the usual health education

结局指标

主要结局

Change from baseline in the compliance with hygiene practices immediately after intervention

时间窗: Day 0, Month 1, Month 2

Knowledge of hygiene practices assessed through a true/false questionnaire.

Change from baseline in the number of participants who comply with hand washing procedures immediately after intervention

时间窗: Day 0, Month 1, Month 2

Hand washing procedure compliance measured using video recordings.

Change from baseline in the number of bacteria on the hands of the participants immediately after intervention

时间窗: Day 0, Month 1, Month 2

Bacterial counts on the hands of participants will be assessed using hand swab sampling and quantitative microbiological analysis. Specifically, hand swabs will be collected from the participants before and after intervention. This will be followed by using plate count method to detect the number of bacterial cells present on the hand swabs collected from the participants.

Change from baseline in the vaccination uptake rates by the participants immediately after intervention

时间窗: Day 0, Month 1, Month 2

Data on vaccination uptake rates will be collected from the participants using a standardized questionnaire before and after intervention. The data will be aggregated to calculate the percentage change in vaccination uptake rates from pre- to post-intervention.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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