A Feasibility Study of the Investigation on the Efficacy of Oral Health Education for Mothers (OHEM) Module for Improving Oral Hygiene in Children.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 540
- 试验地点
- 1
- 主要终点
- Recruitment and participation of participants in the study
研究概览
简要总结
This pilot study evaluates the feasibility of conducting a larger Randomized Controlled Trial to compare three oral health education delivery methods to a control group. Except for the control group, mothers in the three intervention groups will receive the same oral health education based on the OHEM module but differ in the delivery methods, namely lecture, exhibition, and demonstration. All groups will receive a booklet and oral hygiene kits and be instructed to educate their children at home. Pre- and post-intervention assessments include the satisfaction of participants, the researchers' evaluation and cost of the trial, oral hygiene status, and the knowledge of the parents and children.
详细描述
Research question:
There is lacking evidence that oral health education via family-based intervention is effective in improving oral hygiene in children.
OHEM:
A manual, the Oral Health Educational Module (OHEM), has been developed for oral health educators planning a family-based intervention to improve oral health in children by educating and empowering the mothers. OHEM aims to educate mothers about oral health and guide them to share the knowledge with their children. The content includes basic oral health knowledge and the description for preparing and delivering intervention and comes with instruments for assessing the understanding of mothers and children. Educators can choose to carry out the intervention using OHEM via three delivery methods either in a lecture, exhibition, and/or demonstration and each will present the same educational messages.
Objectives:
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
- 12 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The inclusion criteria of the study are based on mothers and children.
- •Inclusion criteria for Mothers:
- •Mothers with children aged 12 to 15 years old, who are residing in Gulshan-e-Sikandarabad with no plan to move within the next 12 months.
- •Mothers with the ability to understand and read the Urdu language.
- •Only biological mothers with good physical and psychological health.
排除标准
- •for mothers:
- •Mothers with new-born
- •Mothers with a history of receiving formal oral health promotion or preventive programs.
- •Inclusion criteria for Children:
- •Aged 12,13,14, and 15 years old (studying in classes 6,7,8, and 9 respectively) residing in union council Gulshan-e-Sikandrabad,
- •Live with biological mothers at home,
- •Present with moderate to severe plaque accumulation and gingivitis during oral screening.
- •Exclusion criteria for Children:
- •Have genetic or medical conditions, such as physical and psychological disabilities that can affect the comprehension of instruction and tooth brushing activities, such as learning disabilities or auditory or visual disorders.
- •Have genetic dental anomalies such as anodontia, amelogenesis imperfecta, and supernumerary teeth.
- •Have been previously exposed to any form of oral health education.
研究组 & 干预措施
OHEM- Lecture
In this arm, OHEM will be delivered by the lecture to the participants.
干预措施: Oral Health Educational Module for Mothers (OHEM) lecture (Behavioral)
OHEM-Exhibition
In this arm, OHEM will be delivered by the exhibition to the participants.
干预措施: Oral Health Educational Module for Mothers (OHEM) exhibition (Behavioral)
OHEM-Demonstration
In this arm, OHEM will be delivered by the demonstration to the participants.
干预措施: Oral Health Educational Module for Mothers (OHEM) demonstration (Behavioral)
Control
There will be no educational intervention given to the control group. However, this group will receive oral hygiene kits and a booklet without instruction to teach their children.
结局指标
主要结局
Recruitment and participation of participants in the study
时间窗: six months
i) How well participants cooperated 1. During the recruitment/baseline data collection 2. During the intervention 3. During the follow-up/ final data collection process Additional comments by the researcher:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ The recruitment will be assessed on a Likert scale rating (very dissatisfied, dissatisfied, somewhat satisfied, satisfied, very satisfied); each item will be reported as the percentage of participants who are at least somewhat satisfied (score 3,4,5), whereas the participation of the participants will be assessed in percentage.
Satisfaction of participants:
时间窗: six months
i. Are you satisfied with the program's organisation? ii. Are you satisfied with the researcher's attitude during the trial? iii. Are you satisfied with the recruitment process? iv. Are you satisfied with the intervention process? v. Are you satisfied with the content taught during the intervention? vi. Are you satisfied with the researcher's delivery of the content? vii. Are you satisfied with arranging the OHEM sessions at the venue? viii. Is the environment at the venue conducive to learning? ix. Are you satisfied with the baseline and final stage of the oral screening process? x. Do you trust the researcher that her research will be fruitful for you and your family? The satisfaction will be assessed using a 10-item questionnaire mentioned in the primary objective. Participants will respond to each question using a 5-point Likert scale rating; each item will be reported as the percentage of participants who are at least somewhat satisfied (score 3,4,5)
Cost of the trial
时间窗: six months
The cost of the trial will be assessed by comparing the cost of the expenditure at the end of the trial. i) Travelling cost, ii) Preparation of materials for the OHEM lecture, exhibition, and demonstration session cost, iii) Conducting the OHEM lecture, exhibition, and demonstration sessions cost, iv) Cost of the incentives for the participants, v) Cost for the volunteers of the trial.
次要结局
- Oral health-related quality of life using Oral health impact profile-14(six months)
- Gingival scores(six months)
- Dental plaque scores(six months)
- Oral health KAP scores(six months)
- Oral health behaviors(six months)
研究者
Dr.Sidra Mohiuddin
Associate Professor
Ziauddin University