The Effect of Filmed Modelling on the Anxious and Cooperative Behaviour of 4-6 Years Old Children During Dental Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Behaviors of Children
研究概览
简要总结
The aim of this study is to evaluate the effect of Filmed modelling in comparison with commonly used Tell-Show-Do technique on the anxious and cooperative behaviour of 4-6 years old children during dental practice.
详细描述
This randomized clinical trial study was approved by ethics committee of Zahedan University of Medical Sciences and conducted in pediatric clinic of Zahedan dental school in 2010.
Among the patients referred to the clinic, forty six children aged 4-6 years (±2 months) were selected according to the inclusion criteria. They had caries lesion in one of the primary mandibular molars needed the pulpotomy and restoration treatment. It was confirmed that they have no previous experience of hospitalization and dental visit. The children with systemic diseases and developmental disorders were excluded from the study. The examination was completed and the necessary radiographies were prescribed.
Each child's parent was asked to complete the informed consent and a questionnaire gathering demographic characteristics of the child and family. Then, the child was enrolled in one of the study groups based on simple random sampling model as follow:
Group I (Tell- Show- Do Group): Children came in the operation room. Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant to increase their familiarity with dental procedures. The duration of the appointment was about 20 minutes and constant for all children. At the end of the first visit, the child was rewarded and the date of the second treatment visit was set for one week later.
In the second session, the child was entered the operating room alone. A video-camera located on the top of the dental unit light pole under a covering cloth was focused on the child's head and hands and started to record child's behavior.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •caries lesion in one of the primary mandibular molars needs to pulpotomy and restoration treatment.
排除标准
- •children with systemic diseases and developmental disorders
- •previous experience of hospitalization
研究组 & 干预措施
tell- show- do procedure
Group I (Tell- Show- Do Group): Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant in the operation room.
In the second session,injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed.
干预措施: tell- show- do (Behavioral)
tell- show- do procedure
Group I (Tell- Show- Do Group): Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant in the operation room.
In the second session,injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed.
干预措施: injection of local anesthesia solution (Drug)
tell- show- do procedure
Group I (Tell- Show- Do Group): Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant in the operation room.
In the second session,injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed.
干预措施: occlusal cavity preparation (Procedure)
film modelling
Group II (Filmed modelling Group): the children were directed to a quiet and comfort room to watch a film presented by a dental assistant. The film showed that the same procedure consisted of Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed on a 5-years-old child model with a time of 20 minutes. The child in the film was cooperative and was reinforced by a reward at the end of the procedure.
In the second session, injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed.
干预措施: film modelling (Behavioral)
film modelling
Group II (Filmed modelling Group): the children were directed to a quiet and comfort room to watch a film presented by a dental assistant. The film showed that the same procedure consisted of Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed on a 5-years-old child model with a time of 20 minutes. The child in the film was cooperative and was reinforced by a reward at the end of the procedure.
In the second session, injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed.
干预措施: injection of local anesthesia solution (Drug)
film modelling
Group II (Filmed modelling Group): the children were directed to a quiet and comfort room to watch a film presented by a dental assistant. The film showed that the same procedure consisted of Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed on a 5-years-old child model with a time of 20 minutes. The child in the film was cooperative and was reinforced by a reward at the end of the procedure.
In the second session, injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed.
干预措施: occlusal cavity preparation (Procedure)
结局指标
主要结局
Behaviors of Children
时间窗: participants followed for the duration of examination and treatment appointment, an expected average of 3 weeks
A video-camera was focused started to record child's behavior. The recorded video tapes were independently evaluated by 2 paediatric dentists who were blind to the grouping of the children. Children's anxiety reactions and cooperative behaviours were scored based on venham scale and Frankle Index ,respectively. quantification was performed at the injection of local anaesthesia and at the beginning of the tooth preparation. An average of both two time points scoring was used. Table 1: Venham 6-point Index 0 = Relaxed: 1 = Uneasy: 2 = Tense: 3 = Reluctant: 4 = Interference: 5 = Out of contact Table 2: Frankle 4-point Index 1:Definitely Negative ( uncooperative,Refusal of treatment ) , 2:Negative ( some evidence of negative attitude but not pronounced) , 3:Positive ( Acceptance of treatment, at times cautious) , 4:Definitely Positive( Good rapport with the dentist)
次要结局
- Index of Heart Rate(before and after the injection of local anesthesia solution)
研究者
mehrsa paryab
assisstant professor
Zahedan University of Medical Sciences