Effectiveness of Audio-Visual Distraction Technique Versus Normal Dental Environment for Management of Anxiety in Pediatric Dental Patients, A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 42
- 主要终点
- Facial Image Scale
研究概览
简要总结
Audio-Visual (AV) Distraction is a recent modality introduced to the entertaining market technology for adults and children. Some practitioners started using this modality of distraction in the dental practice to aid in psychological management of patients.
This study is designed to compare between conventional dental visits (No Distraction) and dental visits aided with audio-visual distraction. Providing a safe, comfortable and entertaining dental environment will give pediatric children a better perception regarding the dental environment and motivate them for repetitive dental visits for better dental health care.
详细描述
[I] Recruitment: Children aged 5~8 years old with teeth decay requiring restorative dental treatment will be randomly selected according to the Intrusion and Extrusion Criteria.
[II] Intervention:
-Steps:
- The operator will select the teeth; child must have decayed tooth requiring restorative dental treatment.
- The visit will be started by using the tell-show-do technique to explain the procedure. After that the Facial Image Scale is validated to assess dental anxiety and will be explained to the child. The dentist will ask the child to choose one of the six faces that best represented his/her current emotional state.
- Pulse oximeter sensor will then be placed and initial pulse rate will be obtained.
- Patient will choose from a bowl a piece of paper to decide if AV-distraction will be used or not.
- Above steps will be done in both visits, with and without the intervention.
- If the toss had AV-distraction, The operator will introduce the Audio-visual device (Virtual Reality Eye Glasses) to the patient and how it works and will allow the patient to choose his favorite show to watch during the dental visit.
- The operator will instruct the patient with the rules that will be applied during the dental visit to assure complete cooperation.
- The operator will apply topical and dental anaesthesia
- Pulse rate will be measured every 5 minutes.
- The operator will allow extra time if the dental visit ended before the child finishes the tv-show.
- Then operator will ask the patient to choose from the face scale diagrams about his anxiety state at the end of the visit.
Intervention modifications:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The statistician is blinded by naming the groupes into group A and group B
.
入排标准
- 年龄范围
- 5 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 5-8 years old.
- •Children with decayed teeth requiring pulp therapy (excluding cases with acute pulpitis)
- •Cooperative children and potentially cooperative
- •Physically and mentally normal children.
- •No previous dental experience involving local anaesthetic administration for the last 2 years
排除标准
- •Children with visual impairment.
- •Children with hearing disabilities.
- •Children with disability complicating the dental treatment as trismus, or TMJ problems.
- •Children with highly inflamed pulp tissue inducing pain during dental visit.
- •Patients or caregivers who refuse to sign the consent.
研究组 & 干预措施
Audio-Visual Distraction Group
In this arm, the patient will be introduced to the audio-visual distraction device and given some instruction on how to use it and rules while using it. other than that, the dental procedure is as same as the other arm group.
干预措施: Nibiru 3D Virtual Reality Headset (Device)
Normal Dental Environment Group
Normal Dental Environment without any distractions.
结局指标
主要结局
Facial Image Scale
时间窗: Immediately right after the dental visit.
To measure dental Anxiety by using Facial Image Scale
次要结局
- Oxygen Saturation (using Pulse oximetry)(During the dental visit)
研究者
Sherif Adel Khalaf Zakhary
Principal Investigator
Cairo University