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临床试验/NCT07365774
NCT07365774已完成不适用

The Role of the "Let's Go to the Dentist!" Video Modelling and Dental Determinants on Dental Anxiety in Children

Wisnu Fadila6 个研究点 分布在 1 个国家目标入组 496 人开始时间: 2024年10月26日最近更新:
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
496
试验地点
6
主要终点
Dental Anxiety Level

研究概览

简要总结

The goal of this clinical trial is to determine if video modelling reduces dental anxiety in children aged 8-12 years in Depok City. The main questions it aims to answer are: Does video modelling exposure significantly lower dental anxiety levels compared to educational video or control groups? Do family sociodemographic factors, dental health knowledge, dental visit patterns, and caries experience contribute to children's dental anxiety? Researchers compare anxiety scores of the video modelling group to the educational video group and control group (no intervention) to assess anxiety reduction effects before and after controlling for confounding factors. Children aged 8-12 years are the participants. Enumerators interview them using the Modified Dental Anxiety Scale Integrated with Facial Image Scale (MDAS+FIS) before and after each intervention, while children watch assigned videos: video modelling (twice), educational video (twice), or none (control). Enumerators record all responses. Children also undergo World Health Organization Decayed, Missing, and Filled Teeth (WHO DMFT/dmft) index dental exams plus interviews about dental knowledge, practices, caries complaints, and visit patterns. Parents complete separate interviews and surveys about family sociodemographics, their own dental knowledge and practice, and their children's dental knowledge, practices, visits, and caries experience.

详细描述

Dental problems affect children worldwide due to sociodemographic factors, high sugar intake, limited access, urbanization, and lifestyle changes, particularly in low and middle income countries. Indonesia's Riset Kesehatan Dasar/Basic Health Research (Riskesdas) 2018 documented 67.3% prevalence among children aged 5-9 years and 55.6% among 10-14 years with only 14.6% and 9.4% accessing professional care respectively, highlighting dental anxiety as a key mediator alongside established risk factors. Family and school environments critically shape children's dental health attitudes, supporting early promotive preventive interventions.

This study tests video modeling, a safe, scalable nonpharmacologic approach leveraging observational learning, against placebo and control conditions. The experimental intervention demonstrates sequential prosocial behaviors through a child model, including calm greeting of dental staff, positive responses to instructions, procedural tolerance without distress, and satisfied departure.

The design evaluates repeated exposure effects, specifically two viewings with 30 minute interval, within urban Depok elementary schools representing diverse socioeconomic contexts. Parental interviews provide additional perspectives alongside quantitative outcomes on dental health determinants, informing national policy translation

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Schoolchildren aged 8-12 years old at time of enrolment
  • Resident of Depok City, West Java, Indonesia
  • Currently enrolled in participating elementary school
  • Parent/legal guardian able to provide written informed consent
  • Child able to provide verbal assent to participate
  • Willing and able to complete study assessments

排除标准

  • Currently receiving orthodontic treatment
  • Reside outside Depok City boundaries (verified post-assessment)
  • Age criteria violation (outside 8-12 year range at assessment)
  • Parent/caregiver unavailable for parent questionnaire interview
  • Incomplete child questionnaire responses on outcome measures
  • Institutional residence (orphanage, boarding school)
  • Inability to provide informed consent/assent

研究组 & 干预措施

Video Modelling

Experimental

Children complete baseline Modified Dental Anxiety Scale Integrated with Facial Image Scale assessment (MDAS+FIS). They then view the "Let's Go to the Dentist!" video (2 minutes 37 seconds). MDAS+FIS is assessed immediately afterward (posttest 1). After a 30-minute wait period, children view the same video again. MDAS+FIS is assessed immediately afterward (posttest 2).

干预措施: "Let's Go to the Dentist!" Video Modelling (Behavioral)

Educational Video

Placebo Comparator

Children complete baseline Modified Dental Anxiety Scale Integrated with Facial Image Scale (MDAS+FIS) assessment. They then view the "Let's Brush Our Teeth!" video (2 minutes 16 seconds). MDAS+FIS is assessed immediately afterward (posttest 1). After a 30-minute wait period, children view the same video again. MDAS+FIS is assessed immediately afterward (posttest 2).

干预措施: "Let's Brush Our Teeth!" General Dental Education Video (Behavioral)

Control

No Intervention

Children complete baseline Modified Dental Anxiety Scale Integrated with Facial Image Scale (MDAS+FIS) assessment. They wait 30 minutes with no video intervention. MDAS+FIS is assessed at matching time points (posttest 1 equivalent and posttest 2 equivalent).

结局指标

主要结局

Dental Anxiety Level

时间窗: Baseline to post-intervention 1 (immediately after first video exposure), then to post-intervention 2 (immediately after second video exposure, 30 minutes after first post-assessment).

Change in dental anxiety scores assessed by the Modified Dental Anxiety Scale Integrated with Facial Image Scale (MDAS+FIS). The MDAS+FIS consists of 5 items scored from 1 to 5, giving a total score range of 5 (lowest anxiety) to 25 (highest anxiety), and higher scores indicate worse (greater) dental anxiety levels.

Dental Health Determinants Assessment

时间窗: Baseline

Structured assessment of: * Sociodemographic factors (age, sex, grade, birth order, parental education, family income, school type) * Dental visit patterns (frequency past 12 months) * Dental health knowledge (toothbrushing frequency, time, caries cause) * Caries experience using World Health Organization Decayed, Missing, and Filled Teeth (WHO DMFT/dmft) index per WHO Oral Health Surveys Basic Methods, 2013.

次要结局

未报告次要终点

研究者

发起方
Wisnu Fadila
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Wisnu Fadila

Doctoral Candidate

Universitas Padjadjaran

研究点 (6)

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