Virtual Reality as a Distraction Technique in Paediatric Dental Care, Assessment of Resulting Effects on Patient Anxiety, Pain and Behaviour
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Child's behaviour assessment (subjective) Child's pain assessment (subjective)
研究概览
简要总结
The aim of this study is to reduce dental anxiety in children by using virtual reality glasses (VRG) with a special content and innovative interactive methods, to determine the level of stress experienced by patients during dental treatment and to ease the workload of dentists.
Within the scope of the study, the participants being examined are in a controlled manner from the practice environment. They are attached a VRG and headphones throughout the treatment. With the help of VRG, it is ensured that participants are ready for the treatment. During the treatment, the participant's focus is on various contents in terms of spectacles. Contents include visual (video surveillance) and auditory stimuli (listening to music). They also provide information about treatment to the patient with the help of avatars (characters) and environmental elements that are placed into the VRG application. In addition, dental anxiety is reduced by the fun contents. The goal is to increase the rate of dental treatment success in child patients.
The effectiveness of virtual reality system is tested by comparing evaluation metrics of three groups of children. In the first group, the dentist carries out the treatment alone. In the second group participants watch cartoons on a screen mounted dental unit during the treatment. In the third group, dental treatment is carried out with VRG. In the course of these experiments, the effects of VRG on dental treatment (vital pulpotomy and dental filling) that require local anesthesia is examined in order to measure the effects of VRG on the level of stress on dental treatment.
Corresponding measures are; (1) the child's anxiety; (2) the child's pain perception during local anaesthesia and treatment; (3) the child's cooperation and general behaviour. The outcomes of the child's anxiety, pain perception, cooperation and general behaviour for three groups were evaluated by statistical analysis.
详细描述
The study is being carried out in Istanbul University Department of Pedodontics, period between March 2021 - December 2021 following the ethics committee approval 2018/5. Patient parents are informed about the study following the initial dental examination of the patient and the written informed consents are obtained from parents of all participants included in the study.
In this randomised parallel clinical study, the sample consisted of 90 children aged between 6-10 years old who applied for routine dental care in paediatric clinic.
Randomization Children are evaluated by the same dentist during the first examination with Frankl Behavior Rating Scale (FBRS) according to their behavioral attitudes and listed by numbers according to the order of application. Participants who do not come to the treatment appointment are recruited again. The volunteers in the top 30 on the list were recruited to Group I (GI), the next 30 volunteers to Group II (GII), and the last group of 30 volunteers to Group III (GIII).
Group I. Dental treatment is carried out using tell-show-do. Group II. Dental treatment is carried out with showing cartoon movie as a passive distraction.
Group III. The active distraction group is treated while wearing the VR headset and interacting with the designed application.
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
- None
入排标准
- 年龄范围
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically and mentally healthy patients without any previous dental treatment experience,
- •Children who required pulpotomy in lower primary molars under local anaesthesia.
排除标准
- •Systemic disease,
- •Mental and cognitive disorders, visual and auditory disabilities.
结局指标
主要结局
Child's behaviour assessment (subjective) Child's pain assessment (subjective)
时间窗: 1 year
According to the The Frankl Behavior Rating Scale, the child's attitude towards treatment is divided into 4 groups and scored between 1-4 meaning: 1 point absolutely negative (child refuses treatment, strong fear and crying), 2 points negative (reluctant to accept treatment), 3 points positive (child accepts treatment, but is cowardly and timid) 4 points absolutely positive (compatible with pediatric dentist).
次要结局
- Child's anxiety assessment (objective)(1 year)
- Child's anxiety assessment (subjective)(1 year)
- Child's pain assessment (subjective)(1 year)
研究者
Yelda Kasımoğlu
Principal investigator
Istanbul University