Effectiveness of an Interactive Video- and Game-Based Oral Health Education Intervention Among 11-Year-Old Schoolchildren in Pulau Pinang: A Cluster Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Change in Oral Hygiene Status Assessed Using the Simplified Debris Index (DI-S)
研究概览
简要总结
The goal of this cluster randomised controlled trial is to learn if an interactive video- and game-based oral health education intervention helps improve oral health outcomes among 11-year-old schoolchildren in Pulau Pinang, Malaysia. The main questions it aims to answer are:
- Does the intervention improve oral hygiene status?
- Does the intervention improve oral health knowledge, attitudes and hygiene practices?
- Does the intervention reduce the frequency of consuming foods that can cause tooth decay (cariogenic foods)?
Investigators will compare a group that receives the video- and game-based oral health education intervention along with a conventional oral health talk to a group that receives only the conventional oral health talk. This will help determine whether the video- and game-based oral health education intervention is more effective than the conventional oral health talk alone.
Participants will:
- Receive either three weekly sessions of the video- and game-based oral health education intervention in addition to a conventional oral health talk, or only the conventional oral health talk.
- Take part in assessments, including a clinical examination to check oral hygiene status and a self-administered questionnaire on oral health knowledge, attitudes, hygiene practices and frequency of cariogenic food consumption. These assessments will take place at three time points: before the intervention, one month after and three months after the intervention is completed.
详细描述
This is a two-arm, parallel-group, single-blinded, cluster randomised controlled trial evaluating the effectiveness of an interactive video- and game-based oral health education intervention among 11-year-old schoolchildren in Pulau Pinang, Malaysia.
The allocation follows a 1:1 ratio. One district will be randomly selected and assigned to the intervention group, and another to the control group, using computer-generated random numbers in IBM SPSS Statistics for Windows, Version 29. Within each district, two government national primary schools will be randomly selected, and from each school, two classes will be randomly chosen. All eligible students in the selected classes, with written parental/guardian consent and written participant assent, will be included.
The control group will receive a conventional oral health talk provided through the school dental service. The intervention group will receive three weekly video- and game-based oral health education sessions delivered by the principal investigator, in addition to the conventional oral health talk.
Assessments will be conducted at three time points: pre-intervention, one month post-intervention and three months post-intervention. The primary outcome is oral hygiene status, while secondary outcomes include oral health knowledge, oral health attitudes, oral hygiene practices and frequency of cariogenic food consumption. Oral hygiene status will be assessed by a calibrated clinician using the Simplified Debris Index (DI-S) while secondary outcomes will be assessed using a validated self-administered questionnaire. The trial is single-blinded, with clinical examiners blinded to group allocation.
Sample size was calculated using G*Power software version 3.1.9.7 for repeated measures Analysis of Variance (ANOVA) (between factors). Assuming an effect size of 0.25, α = 0.05, power = 0.8 and a correlation of 0.5 among repeated measures, the required sample size is 86 participants. After adjusting for a 20% attrition rate and a design effect of 2 for cluster randomisation, the final sample size is 216 participants (108 per group).
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
- 11 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Schoolchildren who are Malaysian citizens.
- •Schoolchildren born in year
- •Schoolchildren studying at government national primary schools under the Ministry of Education Malaysia.
- •Schoolchildren who are able to understand, read and write in Malay language.
排除标准
- •Schoolchildren with underlying chronic medical conditions.
- •Schoolchildren wearing intra-oral appliances.
- •Schoolchildren with learning or intellectual disabilities.
- •Schoolchildren with impaired manual dexterity.
- •Schoolchildren with visual or hearing impairments.
研究组 & 干预措施
Video- and Game-Based Oral Health Education
Participants in the intervention group will receive three video- and game-based oral health education sessions, each delivered one week apart by the principal investigator, in addition to the conventional oral health talk provided through the school dental service.
干预措施: Video- and Game-Based Oral Health Education (Behavioral)
Video- and Game-Based Oral Health Education
Participants in the intervention group will receive three video- and game-based oral health education sessions, each delivered one week apart by the principal investigator, in addition to the conventional oral health talk provided through the school dental service.
干预措施: Conventional Oral Health Talk (Behavioral)
Conventional Oral Health Talk
Participants in the control group will receive a conventional oral health talk provided through the school dental service.
干预措施: Conventional Oral Health Talk (Behavioral)
结局指标
主要结局
Change in Oral Hygiene Status Assessed Using the Simplified Debris Index (DI-S)
时间窗: Pre-Intervention, One Month Post-Intervention and Three Months Post-Intervention
The Simplified Debris Index (DI-S), a component of the Simplified Oral Hygiene Index, will be used to assess the change in oral hygiene status. Six tooth surfaces-buccal of upper and lingual of lower first molars, and labial of upper right and lower left central incisors-will be examined. A no. 5 dental explorer will be used to detect debris, scored as follows: 0 = No debris or stain present; 1 = Soft debris covering not more than one third of the tooth surface being examined or the presence of extrinsic stains without debris regardless of surface area covered; 2 = Soft debris covering more than one third but not more than two thirds of the exposed tooth surface; 3 = Soft debris covering more than two thirds of the exposed tooth surface. The debris scores will be totaled and divided by the number of surfaces assessed to obtain the average score (DI-S), which is classified as 'good' (0-0.6), 'fair' (0.7-1.8) or 'poor' (1.9-3.0).
次要结局
- Change in Oral Health Knowledge, Attitudes and Hygiene Practices Assessed Using a Self-Administered Questionnaire Adapted from the Health Promotion Questionnaire Index (HPQI)(Pre-Intervention, One Month Post-Intervention and Three Months Post-Intervention)
- Change in Frequency of Cariogenic Food Consumption Assessed Using the Self-Administered Malay-Language Cariogenic Food Frequency Questionnaire (M-CFFQ)(Pre-Intervention, One Month Post-Intervention and Three Months Post-Intervention)
研究者
Stephanie Oung Ker Yue
Doctoral Candidate
Universiti Sains Malaysia