Mobile Application Versus Tell-show-do Technique for Improved Behavior Management of Dental Anxiety in Children Aged 7-11 Years: a Multicenter Randomized Control Trial in Karachi-Pakistan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 3
- 主要终点
- Change in Pulse Rate
研究概览
简要总结
This study aims to compare the effectiveness of a mobile application versus the conventional tell-show-do (TSD) technique in reducing dental anxiety among children aged 7-11 years attending their first dental visit. The study is a multicenter randomized controlled trial conducted at tertiary care dental hospitals in Karachi, Pakistan. Participants are randomly assigned to either a mobile application-based behavioral intervention or the TSD technique prior to a dental diagnostic procedure. The primary outcomes include changes in pulse rate and anxiety levels measured using the Raghavendra Madhuri Sujata Pictorial Scale (RMS-PS) before and after the intervention. The findings of this study will help determine whether mobile-based behavioral tools can improve anxiety management in pediatric dental settings.
详细描述
Dental anxiety is a common barrier to effective dental care in children and may lead to avoidance of treatment and poor oral health outcomes. Conventional behavioral management techniques such as tell-show-do (TSD) are widely used; however, the increasing availability of digital tools provides an opportunity to enhance patient preparation and reduce anxiety.
This study is a multicenter, open-label, randomized controlled trial conducted at tertiary care dental hospitals in Karachi, Pakistan. Children aged 7-11 years presenting for their first dental visit are enrolled and randomly allocated to either a mobile application-based behavioral intervention or the conventional TSD technique. The intervention is delivered for a standardized duration prior to a dental diagnostic procedure.
The primary outcomes include changes in pulse rate and anxiety levels assessed using the Raghavendra Madhuri Sujata Pictorial Scale (RMS-PS), measured before and after the intervention. Pulse rate is recorded three times at one-minute intervals at each time point and averaged. Secondary analyses include comparison of outcomes between intervention groups.
The study aims to evaluate whether a mobile application can serve as an effective alternative to traditional behavioral techniques in reducing dental anxiety among children in clinical settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 7-11 years
- •Children with no prior experience of dental treatment i.e. FDV (first dental visit).
排除标准
- •Children with any systematic or mental disorder (given the challenges in communication and participation, children with special needs or serious systemic conditions should be prioritized for appropriate care rather than extending their time in the trial)
- •Children who are physically handicapped
- •Children who are undergoing medical treatment or taking any medication that affects the heart rate (it will affect our outcome measure of pulse rate)
- •Children with heart rate related disorders (which could introduce bias to the heart rate results).
- •Children with significant language barriers or special needs that prevent proper communication and understanding.
研究组 & 干预措施
Mobile Application
A mobile application named Dentist Games will be used as an intervention, the permission to use is obtained from the developers. This mobile application has various dental treatments as games for children to play and virtually act as a dentist and perform dental treatments such as scaling, dental filling, extraction and application of local anesthesia.
干预措施: Mobile Application (Behavioral)
Tell-Show-Do
The control group will receive tell-show-do (TSD) technique. This technique involves a structured sequence where children are initially informed about the impending procedure(tell), followed by the presentation of dental instruments to familiarize them(show), and culminating in a demonstration of the procedure itself in an easily comprehensible manner(do). The TSD will be given for 5 minutes by the dentist
干预措施: Tell-Show-Do Technique (Behavioral)
结局指标
主要结局
Change in Pulse Rate
时间窗: Before and immediately after intervention and dental diagnosis procedure (within same visit)
Pulse rate will be measured three times at one-minute intervals before and after the intervention and averaged to assess change.
Change in Dental Anxiety Score (RMS-PS)
时间窗: Before and immediately after intervention and dental diagnostic procedure (within same visit)
Dental anxiety will be assessed using the Raghavendra Madhuri Sujata Pictorial Scale (RMS-PS) before and after the intervention. A validated child-friendly anxiety scale based on facial expressions.
次要结局
未报告次要终点
研究者
Fasahat Khan
Postgraduate Student, Department of Community Health Sciences, Aga Khan University
Aga Khan University Hospital, Pakistan