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临床试验/NCT04923581
NCT04923581已完成不适用

Effect of Optimized Behavioural Intervention Using The Multi-Phase Optimization Strategy (MOST) on Oral Hygiene Habits of Pre-school Children in Egypt.

Merna Ihab2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2023年7月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
128
试验地点
2
主要终点
Change in the plaque index scores of participating children

研究概览

简要总结

In the current study, MOST approach is proposed, to engineer an oral health behavior modification intervention, to increase the engagement of mothers in brushing their pre-school children's teeth.

详细描述

The first phase of this study will be the preparation phase. This will comprise the development of a conceptual framework and conducting a feasibility pilot study consisting of three intervention components: Motivational interviewing (MI), Oral health promotion messages (OHPm), and Storytelling (ST). The second phase of the study is the optimization phase which constitutes a factorial trial of the three selected intervention components (MI, OHPm and ST). Each component will be set at two levels: yes (the intervention is applied) vs no (the intervention is not applied).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
None

入排标准

年龄范围
2 Years 至 5 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •for mother's of children enrolled in study:
  • •Has children between 2 and <5 years of age
  • •Has children with high plaque index scores (PlI≥2 or visible plaque accumulation on maxillary anterior teeth).
  • •Literate and owns a mobile phone with already set-up or possibility to set-up Whats-App messenger application.
  • •Willing to participate in the study and receive periodic OHPm and ST videos.

排除标准

  • •Mothers of children who are not willing to cooperate and show a definite negative behavior (Rating 1 Frankel's classification).
  • •Mothers of children who are physically disabled or medically compromised.
  • •Mothers of children in need of emergency dental treatments.

研究组 & 干预措施

Condition 1

Experimental

Participants will receive the constant component only.

干预措施: Oral Health Behavioral Interventions (Behavioral)

Condition 2

Experimental

Participants will receive the constant component and storytelling videos .

干预措施: Oral Health Behavioral Interventions (Behavioral)

Condition 3

Experimental

Participants will receive the constant component and oral health promotion messages.

干预措施: Oral Health Behavioral Interventions (Behavioral)

Condition 4

Experimental

Participants will receive the constant component, oral health promotion messages, and storytelling videos.

干预措施: Oral Health Behavioral Interventions (Behavioral)

Condition 5

Experimental

Participants will receive the constant component and motivational interview session.

干预措施: Oral Health Behavioral Interventions (Behavioral)

Condition 6

Experimental

Participants will receive the constant component, motivational interview session, and storytelling videos.

干预措施: Oral Health Behavioral Interventions (Behavioral)

Condition 7

Experimental

Participants will receive the constant component, motivational interview session, and oral health promotion messages.

干预措施: Oral Health Behavioral Interventions (Behavioral)

Condition 8

Experimental

Participants will receive the constant component, motivational interview session, oral health promotion messages and storytelling videos

干预措施: Oral Health Behavioral Interventions (Behavioral)

结局指标

主要结局

Change in the plaque index scores of participating children

时间窗: at baseline, 3 and 6 months

Measured by the Plaque index of Silness and Loe. Lower plaque scores indicate better oral hygiene

Change in children's frequency of toothbrushing and use of fluoridated toothpaste

时间窗: at baseline, 3 and 6 months

Using the World Health Organization questionnaire. Highrr tooth brushing frequency indicates better oral hygiene

次要结局

未报告次要终点

研究者

发起方
Merna Ihab
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Merna Ihab

Teaching Assistant

Alexandria University

研究点 (2)

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