Using a Handheld Mirror to Improve Child's Behavior During Dental Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Number of instances of child's disruptive behavior defined by the Anxious and Disruptive Behavior Code
研究概览
简要总结
The purpose of this study is to determine whether a handheld mirror helps to reduce child behavior problems during dental treatment. It will be tested by randomized crossover design. Child participants will receive dental treatment under two conditions: during one of the treatment days the child will be given a handheld mirror; another treatment will be done without the child having the mirror. Each condition will be assign on separate days, and the day, which the child has the mirror, will be assigned by chance.
详细描述
Participants, including 3-17 years old children and primary caregivers as well as pediatric dentists and dental assistants, will be recruited at the Irving and Jeanne Tapper Pediatric Dental Center at University Hospitals Rainbow Babies & Children's Hospital in Cleveland, Ohio. Instructional sessions will provide proper use of a handheld mirror to pediatric dentists and dental assistants.
On the first dental appointment:
After obtain consent and assent form, the caregiver will be asked to complete a questionnaire, "Questionnaire for Caregiver", which includes questions to assess the caregiver's dental anxiety level, the caregiver's perception of the child's dental fear level, and collect characteristic information such as age and gender. The child will also be asked to complete a questionnaire; a 3-6 years old child will complete the questionnaire "Questionnaire for Child 3-6," which includes the face image scale to measure his/her level of dental anxiety; a 7-17 years old child will complete the questionnaire "Questionnaire for Child 7-17," which includes the face image scale and the Dental Subscale of the Children's Fear Survey Schedule (CFSS-DS) to measure his/her level of dental anxiety.
The child will then be randomly assigned to either Group 1, in which the child will receive the dental treatment with the mirror at the first visit and receive dental treatment without the mirror at the second visit, or Group 2, which will receive dental treatment without the mirror on the first visit and receive dental treatment with the mirror on the second visit. The child's, dentists' and dental assistants' behavior will be video recorded during treatment. The dentist will guide the child to see the inside of his or her mouth during the dental care procedure. At the end of appointment, children who are 7 -17 years old will be asked the ease of receiving dental treatment by a 5 point Likert scale.
On the second appointment, the same procedure will occur including the questionnaire and video recording.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A dyad of children who are 3-17 years of age and their primary caregiver
- •Children who need at least two restorative appointments
- •Primary caregivers who are fluent in English
排除标准
- •Children who have a visual impairment
- •Children who need protective stabilization to immobilize children's body for treatment
- •Children who are not able to hold the mirror
- •Children who don't have ability to answer the questions
结局指标
主要结局
Number of instances of child's disruptive behavior defined by the Anxious and Disruptive Behavior Code
时间窗: Child's disrupted behavior will be measured for the duration of dental treatment (up to 1 hour).
The Anxious and Disruptive Behavior Code which includes head movement, body movement, complaints and crying, and restraints is used to count child's disrupted behavior during dental treatment.
次要结局
- Child's cooperative behavior level assessed by Frankle's Cooperative Behavior Scale(Child's cooperative behavior will be measured for the duration of dental treatment (up to 1 hour).)
研究者
Masahiro Heima
Assistant Professor
Case Western Reserve University