Mobile App (Little Lovely Dentist) Versus Tell-Show-Do Technique in Reduction of Anxiety and Pain During Administration of Local Anaesthesia in Children (A Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Preoperative anxiety score
研究概览
简要总结
To evaluate the mobile games' effect on patient acceptance of local anesthesia and decreasing dental pain and anxiety levels in pediatric patients.
详细描述
a randomized clinical trial with parallel-group and allocation ratio (1:1). intervention group: mobile application (little lovely dentist) control group: Tell-Show-Do technique. in children aged 4-6 years who need local anesthesia for dental treatment during their first dental visit.
For both groups:
Verbal assent from participating patients and written consent from their legal guardians will be taken.
- Taking personal data, medical and dental history.
- Diagnosis and determination of the required treatment.
- Measuring preoperative anxiety using a pulse oximeter.
- Evaluate preoperative anxiety using RMS-pictorial scale.
- Using the behavior guidance technique:
Intervention group: Allow the child to play the module simulating the required procedure. Control group: tell-show-do technique is used to explain the procedure to the child 6. Administration of local anesthesia and evaluation of child behaviour during the administration of local anaesthesia using Venham's behaviour rating scale and Frankl behaviour rating scale . 7. Measuring postoperative anxiety using the pulse oximeter. 8. Evaluate postoperative anxiety using RMS-pictorial scale. 9. Evaluate postoperative pain using the visual analog scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 4-6 years.
- •Children without any systemic or mental disorders.
- •Children without any prior experience with the dental environment or treatment procedures (first dental visit).
- •Children whose behavior could be rated as positive or negative based on the Frankl behavior rating scale.
排除标准
- •Children seeking dental treatment that does not necessitate local anesthesia.
- •Children suffering from any systemic or mental disorders.
- •Children who are not willing to participate in the study
研究组 & 干预措施
mobile application (little lovely dentist).
intervention mobile application simulating the dental procedure that will be done to the child
干预措施: mobile application (little lovely dentist). (Behavioral)
Tell-Show-Do technique.
control behavior technique where ''tell'' is to tell the child about the procedure in non-threatening words, ''show'' is to demonstrate the procedure to the child, and ''do'' is the execution of the procedure
结局指标
主要结局
Preoperative anxiety score
时间窗: before administration of local anesthesia during the first dental visit
will be assessed by RMS-pictorial scale ( Raghavendra, Madhuri, Sujata - pictorial scale) before administration of local anesthesia in a numerical unit from 1-5 where 1 denotes the minimum anxiety and 5 denotes the maximum anxiety
post-operative anxiety score
时间窗: immediately after administration of local anesthesia during the first dental visit
will be assessed by RMS-pictorial scale ( Raghavendra, Madhuri, Sujata - pictorial scale) immediately after administration of local anesthesia in a numerical unit from 1-5 where 1 denotes the minimum anxiety and 5 denotes the maximum anxiety
postoperative anxiety
时间窗: immediately after administration of local anesthesia during the first dental visit
postoperative anxiety will be measured immediately after administration of local anesthesia using a fingertip pulse oximeter (IMDK) in beat per minute unit (BPM)
Preoperative anxiety
时间窗: before administration of local anesthesia during the first dental visit
Preoperative anxiety will be measured before administration of local anesthesia using a fingertip pulse oximeter (IMDK) in beat per minute unit (BPM)
次要结局
- Attitude during the first and second dental visits using Venham's behavior rating scale(during administration of local anasthesia during the first and second dental visits (after 1 week))
- Attitude during the first and second dental visits using frankle behavior rating scale(during administration of local anasthesia during the the first and second dental visits (after 1 week))
- Postoperative pain(immediately after administration of local anesthesia during the first dental visit)
研究者
Marian Mamdouh Sedky Reda
Principle investigator
Cairo University