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临床试验/CTRI/2022/09/045359
CTRI/2022/09/045359尚未招募不适用

The Efficacy of Roogies dental app and Tell-Show-Do Techniques in Alleviating Dental Anxiety in Pediatric Patients: A Randomized controlled trial

Rusheeka Kake1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2022年12月9日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
52
试验地点
1
主要终点
which is a physiological representation of anxiety

研究概览

简要总结

Dental anxiety in children presents a challenge to the child, parents and the dental team. The children who suffer from dental anxiety and fear range from 5 to 33% throughout the world and are ranked as the fourth common fear. The first dental visit is crucial in the formation of the child’s attitude toward dentistry and future treatment success. Therefore, a pleasant experience normally generates a sense of ease and trust in the dentist, while a traumatic experience leads to avoidance of visiting the dentist. Behavior guidance is a teaching technique that requires interactions between the dentist, dental team, patient, and parents. Tell-show-do technique, introduced by Addelston in 1959, remains the cornerstone of behavior management techniques. With the advancement in technology, mobile dental apps that are used for behavior guidance has led to the development of virtual reality immersion. A novel, Roogies dental app which is based on cognitive-behavioral techniques such as systematic desensitization, modelling, distraction and guided imagery is created. 

**Aim:**To evaluate and compare the efficacy of Roogies dental app and TSD in the management of child’s dental anxiety

Objectives:

1. To obtain anxiety levels in the two groups before, immediately after intervention and after completion of the procedure using physiological(Heart rate by pulse oximeter) and subjective(FIS and RMS scale) measures.

2. To compare the anxiety levels in the two groups before, immediately after the intervention, and after completion of the procedure using physiological (Heart rate by pulse oximeter) and subjective(FIS and RMS scale) measures.

3. To compare the anxiety levels using the Facial image scale (FIS) and RMS scale.

Methodology:

52 Children aged 6-11 years attending the Department of Paediatric and Preventive Dentistry who are indicated for restorative procedures will be divided into two groups(26 per each group) by simple random sampling. Before including them in the trial, informed and written consent was taken from the child’s parents or guardians.

Group I: "Roogies" mobile dental app

Group II: Conventional Tell-Show-Do technique

The Roogies app is a technological behaviour guidance tool, and it was created taking into account cognitive-behavioural principles.

Roogies application demonstrates the procedures such as Atraumatic restorative treatment, conventional dental filling, and placement of crowns of each treatment step in the form of video.

For the tell-show-do technique, in the "tell" part, there is a verbal explanation for the dental procedure appropriate to the child’s developmental level. In the "show" aspect, demonstration of various instruments was provided to the child in a friendly style to build their confidence and lastly, in the "do" part, the dentist performed the desired procedure precisely as explained to the child.

As explained during the intervention, dental restorative procedures will be performed on all the participants.

The anxiety levels will be recorded before, immediately after intervention and after completion of the procedure using physiological (pulse oximeter) and subjective (FIS and RMS scale).

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Not Applicable

入排标准

年龄范围
6.00 Year(s) 至 11.00 Year(s)(—)
性别
All

入选标准

  • 1.Children without any prior experience with the dental treatment procedures.
  • 2.Children who comes under frankl behavior rating 2 and 3.

排除标准

  • 1.Children with any systemic disorders or special health care needs.
  • 2.Children or parents who refused to participate in the study.
  • 3.Children who complain of pain.

结局指标

主要结局

which is a physiological representation of anxiety

时间窗: 1. Before intervention-Baseline(Roogies dental app/Tell-Show-Do) | 2. After 5 minutes of intervention(Roogies dental app/Tell-Show-Do) | 3. After the dental procedure (30 minutes)

or fear

时间窗: 1. Before intervention-Baseline(Roogies dental app/Tell-Show-Do) | 2. After 5 minutes of intervention(Roogies dental app/Tell-Show-Do) | 3. After the dental procedure (30 minutes)

Heart rate will be measured using pulse oximeter,

时间窗: 1. Before intervention-Baseline(Roogies dental app/Tell-Show-Do) | 2. After 5 minutes of intervention(Roogies dental app/Tell-Show-Do) | 3. After the dental procedure (30 minutes)

次要结局

  • Facial Image Scale(FIS) and RMS scale will be used to measure anxiety, which is a subjective measure(1. Before intervention-Baseline(Roogies dental app/Tell-Show-Do))

研究者

发起方
Rusheeka Kake
申办方类型
Other [self-sponsored]

研究点 (1)

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