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临床试验/NCT07072559
NCT07072559Enrolling By Invitation不适用

Effect of a Dental Simulation Game on Reducing Pain and Anxiety During Primary Teeth Pulpotomy in Pediatric Patients: A Randomized Controlled Clinical Study

Mansoura University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2025年1月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
44
试验地点
1
主要终点
Frankl's behavior scale

研究概览

简要总结

The aim of this study is to evaluate the effect of a dental simulation game on reducing pain and anxiety during primary teeth pulpotomy.

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
Double (Participant, Investigator)

入排标准

年龄范围
4 Years 至 7 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •1- Children aged between 4 to 7 years of both sexes. 2- Children with behavior rating score 2 and 3 according to Frankl's behavior rating scale.
  • •3- Children with carious lesions indicated for pulpotomy. 4- Restorable primary lower molars.

排除标准

  • •1- Children with special health care needs. 2- Children suffering from systemic diseases.

研究组 & 干预措施

Dental simulation game

Experimental

22 children For the experimental group (group 2) dental simulation game, use the dental simulation game as educational game about procedure this game includes multiple dental procedures like filling cavities, performing root canal treatments, extracting decayed teeth, and conducting orthodontic procedures for animalsAt the first visit children will play on any procedure in dental simulation game, after that the child will be shown two animals, after which they virtually do a root canal procedure. Tasks include performing a dental X-ray, anesthetizing the tooth using a syringe, drilling decayed cavity and start pulp treatment, rinsing, pulp treatment and filling the tooth, applying light cure and finally polishing the teeth . The second visit for pulpotomy procedure will be scheduled two days after first visit. Children will be managed using the TSD (Tell-Show-Do) technique

干预措施: dental simulation game (Other)

Tell show do

Other

22 children For the control group (group 1) TSD (Tell-Show-Do) technique group, children will be managed with a verbal explanation and a friendly, non-threatening demonstration of the upcoming dental treatment. The "do" phase involved carrying out the dental procedure as per the prior explanation and demonstration.

干预措施: tell show do (Other)

结局指标

主要结局

Frankl's behavior scale

时间窗: behavior of child will be assessed at baseline .same visit

The behavior of child will be assessed before treatment, after administration of local anesthesia and finally after pulpotomy using Frankl's behavior rating scale

Venham scale

时间窗: anxiety of child will be assessed at baseline .same visit

Anxiety levels of child patient will be assessed by Venham scale. First, explain to patient of all group to select most suitable face that matched with level of anxiety after administration of local anesthesia and after pulpotomy procedure done.

Wong baker scale

时间窗: pain level of child will be assessed at baseline .same visit

Pain levels of child patient will be assessed after administration of local anesthesia and finally after pulpotomy using Wong baker scale

pulse rate

时间窗: vital sign of child will be assessed at baseline.same visit

Measuring the pulse rate will be by using finger pulse oximeter before treatment, after administration of local anesthesia and at the end of pulpotomy

Frankl's behavior scale

时间窗: behavior of child will be assessed at baseline .same visit

The behavior of child will be assessed before treatment, after administration of local anesthesia and finally after pulpotomy using Frankl's behavior rating scale

Venham scale

时间窗: anxiety of child will be assessed at baseline .same visit

Anxiety levels of child patient will be assessed by Venham scale. First, explain to patient of all group to select most suitable face that matched with level of anxiety after administration of local anesthesia and after pulpotomy procedure done.

Wong baker scale

时间窗: pain level of child will be assessed at baseline .same visit

Pain levels of child patient will be assessed after administration of local anesthesia and finally after pulpotomy using Wong baker scale

pulse rate

时间窗: vital sign of child will be assessed at baseline.same visit

Measuring the pulse rate will be by using finger pulse oximeter before treatment, after administration of local anesthesia and at the end of pulpotomy

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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