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临床试验/CTRI/2025/02/081375
CTRI/2025/02/081375尚未招募不适用

Comparative evaluation of Tell play do with smart phone digital dentist game and Stress ball in reducing anxiety in children aged 6-10 years: a randomized controlled trial

College Of Dental Sciences, Amargadh, Bhavnagar, Gujarat1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2025年8月18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
180
试验地点
1
主要终点
To assess children anxiety

研究概览

简要总结

A randomized controlled trial will be carried out on 180 children aged 6-10 years who will be reporting to the Department of Pediatric and Preventive dentistry, College of Dental Sciences, Amargadh, Bhavnagar, Gujarat  indicated for the treatment of class I restoration.Written informed consent will be taken before conducting the study.

A total of 180 children will be taken for the study which will be divided in to 3 different groups.

60 children will be allocated to each group which will be divided in to:

 Group A (control group):Tell  show do technique

 Group B (experimental group 1) : Tell play do with smart phone digital dentist game

 Group C (experimental group 2): Stress ball

 Group A (control group):Tell  show do technique will be used to reduce dental anxiety level.In this group, verbal explanation of the treatment procedure will be given to the child; the child will be explained exactly what is going to be done. After the explanation, demonstration of the visual, auditory, and tactile aspects of the procedure will be given to the child. The child will be shown all the instruments and materials required for the treatment, and the child will be made aware of the airotor noise. The child will also be shown how the airotor, three-way syringe, and suction work. Afterward, the child will be taken for the treatment, and the restorative procedure will be performed.

 Group B (experimental group 1) : Tell play do with smart phone digital dentist game will be used. In this technique, children will play a dentist game on a smartphone (Baby Panda Dental Care game) to learn about dental tools in a fun way for 5-10 minutes before starting the procedure. I will explain to the child everything that is shown in the game and  participate in the activity by playing the game with the child to educate them about the dental treatment procedures, such as restorations, that will be performed on them. After that, the procedure will be started. This game’s ability to combine education with entertainment, along with its proven popularity and positive feedback from parents, makes it the most suitable choice for my study. Its rating is also better compared to other dentist games on the Play Store.

Group C (experimental group 2): Stress ball will be used.In this technique we will have 3 sizes (small,medium,large) of squeeze ball which will be shown to the children so they can choose one according to their comfort and before conducting the procedure children will be instructed to squeeze the ball for 5-10 minutes and after that procedure will be started.

Samples in each group will be treated in a single appointment after using either of the behaviour modification techniques.Class I cavities will be prepared on carious primary molar and will be restored using Glass ionomer cement.

This study is designed as a single blind (participants), randomized controlled trial with two parallel groups.  Samples will be randomly allocated to the study groups by simple randomization by lottery method for equal distribution of sample size in study group.

 In this study Anxiety of the subject will be assesed before,during (immediately after cavity preparation) and after the treatment objectively by pulse rate with the help of pulse oximeter (by DR VAKU) and subjectively by chotta bheem chutki scale in all the three groups.

CBC scale is a newly designed scale. This scale comprises two separate cards; one for boys and the other for girls.For boys, the Chotta Bheem cartoon character will be chosen to depict various emotions, and for girls, the Chutki cartoon character will be chosen to depict various emotions. Each card will consist of a series of six figures, ranging from happy to unhappy, with the cartoon character displaying different emotions. Children will be asked to choose the face they identify with at that moment. To record on the scale, a score of one will be assigned to the happy face, and six will be assigned to running.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
6.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • Children in the age range of 6-10 years.
  • Children of both sexes.
  • Class I carious lesion on the primary molars who requiring a restoration without local anesthesia.

排除标准

  • 1.Children with special health care needs.
  • (Physically and mentally challenged).
  • 2.Parents of children who refuse to give consent.
  • 3.Extensively damaged teeth.

结局指标

主要结局

To assess children anxiety

时间窗: Before, During and After the procedure

次要结局

  • Reduction in dental anxiety(Variation of pulse measured using pulse oximeter before, during and after the procedure)

研究者

发起方
College Of Dental Sciences, Amargadh, Bhavnagar, Gujarat
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Chetan Zinzala

College of Dental Sciences, Amargadh, Bhavnagar, Gujarat

研究点 (1)

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