Effectiveness of Puppet Modeling Technique on Children Undergoing Stressful Dental Procedures' Randomized Clinical Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Facial Image Scale
研究概览
简要总结
The goal of this RCT is to compare puppet modeling technique vs tell show and do on children undergoing stressful dental procedures'
- The main question[s] it aims to answer are:
- To compare the effect of puppet modeling vs tell show and do on the cooperation of children during the administration of local anesthesia.
- To compare the effect of puppet modeling vs tell show and do on the anxiety level of children during the administration of local anesthesia.
type of study: clinical trial participant population/health conditions: Healthy
In this randomized crossover clinical trial, study subjects were randomly allocated into two groups:
- Group I : Children who received puppet behavior guidance during their first visit and tell-show-do guidance in their second visit, 2 weeks later. (P-TSD)
- Group II : Children who received the tell-show-do behavior guidance during their first visit and puppet behavioral guidance in their second visit, 2 weeks later.(TSD-P)
详细描述
Aim of the Study: The aim of this research is to compare the effectiveness of tell show and do (TSD) vs puppet play therapy on children's behavior during the administration of local anesthesia.
Materials and Methods
This was a randomized crossover clinical trail that was conducted at King Abdulaziz University Faculty of Dentistry for a period of 12 months starting from Jan 2023 to Dec 2023 on 41 children (aged 3-7 years) randomly divided into two groups of. Group I (23 children): Children who received the TSD behavior guidance during their first visit and puppet play therapy in their second visit 2 weeks later. Group II (18 children): Children who received puppet play therapy during their first visit and TSD guidance in their second visit 2 weeks later. The anxiety level was determined using Facial Index Scale(FIS) and Venham anxiety rating scale and pulse rate (PR) at the beginning, middle and the end of each anesthesia administration. Patient behavior was also scored using Frankl behavior rating scale (FBRS) , Venham behavior rating scale. The FLACC scale was used to assess pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Two evaluators, who are blinded to the experimented techniques, watched recorded videos of both groups separately and gave their behavior assessment.
入排标准
- 年龄范围
- 3 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Children having no previous experience of local anesthesia
- •Children aged 3-8 years old
- •Children with negative history of any particular underlying disease.
排除标准
- •• Children who needed procedures with no local anesthesia.
- •Children who were allergic to local anesthesia.
- •Children who were indicated for advanced behavioral guidance.
研究组 & 干预措施
Group 1
Children who received puppet behavior guidance during their first visit and tell-show-do guidance in their second visit, 2 weeks later. (P-TSD)
干预措施: Tell Show and Do Guidance (Behavioral)
Group 1
Children who received puppet behavior guidance during their first visit and tell-show-do guidance in their second visit, 2 weeks later. (P-TSD)
干预措施: Puppet Guidance (Behavioral)
Group 2
Children who received the tell-show-do behavior guidance during their first visit and puppet behavioral guidance in their second visit, 2 weeks later.(TSD-P)
干预措施: Tell Show and Do Guidance (Behavioral)
Group 2
Children who received the tell-show-do behavior guidance during their first visit and puppet behavioral guidance in their second visit, 2 weeks later.(TSD-P)
干预措施: Puppet Guidance (Behavioral)
结局指标
主要结局
Facial Image Scale
时间窗: through study completion, an average of 1 year
The FIS comprises a row of five faces ranging from (1) very happy to (5) very unhappy. It is simple, efficient measure of anxiety in very young children than other measures of anxiety that depend on the cognitive ability of the child
Frankl behavior rating scale
时间窗: through study completion, an average of 1 year
It classifies child behavior into four groups according to the child's attitude during dental treatment: (4)Definitely positive, (3) Positive, (2) Negative, and (1) Definitely negative.
FLACC Pain scale
时间窗: through study completion, an average of 1 year
Pain is assessed through observation of 5 categories including face, legs, activity, cry, and consolability. Each category will be given a score ranging from 0 to 2. The final score is calculated by adding up the scores of the five categories for a final score out of 10.
Heart rate
时间窗: through study completion, an average of 1 year
The heart rate was measured throughout the procedure using Gibson finger oximeter. Three readings were recorded. One before the administration of local anesthesia, one during the injection and one immediately after.
Venham Scale of Dental behavior
时间窗: through study completion, an average of 1 year
The Venham Scale of Dental behavior is an interval rating scale with the interval ranking from 0 (extremely cooperative) to 5 (extremely uncooperative).
Vehnam Anxiety Rating Scale
时间窗: through study completion, an average of 1 year
The Vehnam Anxiety Rating Scale was used in this clinical trial to measure the patient's situational dental anxiety. This scale is an interval rating scale with the interval ranging from 0 (the least anxious score) to 5 (the most anxious
次要结局
未报告次要终点
研究者
Layla Khogeer
Dr
King Abdulaziz University