Effect of Virtual Reality Distraction Versus Audio Distraction on Anxiety and Pain Reduction in Children Undergoing Dental Treatment (A Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 入组人数
- 44
- 主要终点
- preoperative anxiety
研究概览
简要总结
The aim of the study is to evaluate and compare the effect of virtual reality glasses (VR) as an audiovisual distraction method to audio distraction using music on child's dental anxiety during dental treatment.
详细描述
a randomized clinical trial with parallel-group and allocation ratio (1:1). intervention group: audiovisual distraction using virtual reality glasses control group :audio distraction using music. in children aged 5-8 years who need dental extraction for primary molars.
For both groups:
- Taking personal data, medical and dental history.
- Diagnosis and determination of the required treatment.
- Measuring preoperative anxiety (expressed by heart rate) using a pulse oximeter.
- Using the behavior guidance technique:
Intervention group: The Child is introduced to the virtual reality glasses device, and was given instructions on how to use it and was allowed to choose one of previously chosen cartoons to be played during the procedure.
Control group: The child is introduced to the headphones and was given instructions on how to use it, and a relaxing music is played during the procedure. 5. Administration of topical anesthesia. 6. Administration of local anesthesia. 7. Check the effectiveness of local anesthesia using dental probe. 8. Extraction of the affected tooth. 9. Measuring postoperative anxiety (expressed by heart rate) using the pulse oximeter. 10. Evaluate the objective pain using Face, Legs, Cry, Consolabiliy scale . 11. Self-reporting of subjective pain using Visual analogue scale. 12. Post extraction instructions are given to the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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.
- •Children without any mental or systemic disorder.
- •Children need extraction of primary molars under local anesthesia.
排除标准
- •Children with visual impairment.
- •Children with hearing disabilities.
- •Patients or caregivers who refuse to sign the consent.
结局指标
主要结局
preoperative anxiety
时间窗: before administration of local anesthesia
Preoperative anxiety will be measured before administration of local anesthesia using a fingertip pulse oximeter in beat per minute unit (BPM)
postoperative anxiety
时间窗: immediately after dental extraction
using a fingertip pulse oximeter in beat per minute unit (BPM)
次要结局
- subjective pain(immediately after extraction.)
- objective pain(during dental extraction procedure.)
研究者
Omneya Ahmed AbdelRazik saleh
principle investigator
Cairo University