Evaluation of the Effect of Parental Absence on Child's Dental Anxiety and Behaviors During Dental Treatment: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Heart rate measurement to assess dental anxiety
研究概览
简要总结
The basis of pediatric dentistry is to provide cooperation in children with various behavioral management techniques. The presence or absence of the parent during dental treatments can be used to ensure the child's compliance with the treatment.
The aim of this study is to investigate the effect of the presence or absence of the parent on the child's dental anxiety and child's behavior during dental treatment. The secondary aim is to examine the relationship between the child's dental fear and the parent's dental fear.
Healthy children between the ages of 4-7, who have no dental experience and need restorative treatment will be included in the study. Participants will be randomly assigned to one of three study groups (Group 1: Parental absence, Group 2: Parent behind a barrier and Group 3: Parental presence).
Psychometric and projective tests will be applied to assess child's and parent's dental anxiety at the beginning of the study.
At the second appointment scheduled for the operative treatment of decayed primary molar tooth, first the child will be administered topical and local anesthesia, a rubber dam will be placed on the decayed tooth, the caries will be removed with high and low speed rotary instruments and the cavity will be restored with a compomer filling.
Children's heart rates and blood oxygen saturation will be measured by a pulse oximeter during treatment in order to evaluate dental anxiety. Children will be videotaped during treatment so that their behaviour can be evaluated later by another researcher.
After treatment, psychometric and projective tests used to measure the child's dental anxiety will be re-administered.
详细描述
The aim of this clinical study is:
- to determine the presence or absence of the parent during the treatment in order to ensure the cooperation of the child during the dental treatment
- to investigate the relationship between the parent's dental fear and the child's dental fear
72 healthy children aged 4-7 will be recruited from Ankara Yıldırım Beyazıt University Faculty of Dentistry, Department of Pediatric Dentistry outpatient clinic.
Participants who met the inclusion criteria and agreed to participate will be randomly allocated to Group 1 (Parental absence), Group 2 (Parent behind a barrier) or Group 3 (Parental presence).
A simple randomization method will be used with opaque sealed envelopes containing "Group 1", "Group 2" or "Group 3" prepared separately for 4 different ages (4, 5, 6 and 7) in the study. Group allocation will be performed by an independent researcher, not involved in the study.
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 (Investigator, Outcomes Assessor)
盲法说明
Researcher evaluating child's behavior by watching video recordings taken during dental treatment and biostatistician will be blinded.
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
- •No previous dental treatment experience
- •No need for urgent dental treatment
- •Presence of at least one interproximal carious lesion in a primary molar tooth with a lesion depth does not exceeding 1/2 of the inner dentin radiographically and without irreversible pulp pathology
排除标准
- •Any systemic disease, physical or mental disorder
- •Uncooperative child who absolutely refuses dental treatment
结局指标
主要结局
Heart rate measurement to assess dental anxiety
时间窗: during dental treatment
Measurement will be made with a pulse oximeter
Mean change from baseline in children's dental anxiety scores on Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) at the end of the dental treatment.
时间窗: 1. At the first visit- immediately after being assigned to one of the three study arms; 2. At the second visit- within 30 min after dental treatment
The CFSS-DS is a 15-item questionnaire on various aspects of dental treatment. Each item can be given five different scores ranging from "not afraid at all (1)" to "very much afraid (5)." The CFSS-DS has a total score range of 15 to 75 and a score of 38 or more has been associated with clinical dental fear.
Frankl behavioral scale to measure compliance to dental treatment
时间窗: during dental treatment
Frankl behavior scale classifies child behavior into four categories (1-definitely negative 2- negative, 3- positive and 4- definitely positive) according to the child's attitude during dental treatment. The video recording taken during the treatment will be evaluated by another researcher. In the "parental presence group" where the parent accompanies the child, the parent will be seated outside the camera's field of view.
Mean change from baseline in children's dental anxiety scores on Venham Picture Test at the end of the dental treatment.
时间窗: 1. At the first visit- immediately after being assigned to one of the three study arms; 2. At the second visit- within 30 min after dental treatment
The Venham picture test is comprised of 8 pairs of images, where each pair represents one anxious figure and one non-anxious figure. The children are asked to select the ones that reflect their emotional state best. The anxious figure gets 1 point, and the non-anxious figure gets 0 points. The final score ranges from 0 (least anxious) to 8 (most anxious).
Blood oxygen saturation measurement to assess dental anxiety
时间窗: during dental treatment
Measurement will be made with a pulse oximeter
次要结局
- The Corah Dental Anxiety Scale to measure the parent's dental anxiety(At the first visit- immediately after being assigned to one of the three study arms)
研究者
AYŞE IŞIL CİHAN
Professor
Ankara Yildirim Beyazıt University