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临床试验/CTRI/2024/02/062788
CTRI/2024/02/062788已完成3 期

Effect of distraction using virtual reality on anxiety in children during administration of local anaesthesia: A clinical study.

Dr Farkhaunda Ilyas1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年2月28日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Determined from:

研究概览

简要总结

A Clinical study which includes total of 60 children of aged 5 to 12 year old will be included in the study based on the (MCDAS(f)).2 They will be divided in two study groups (group I and group II) based on split-mouth design and assigned to the left or right quadrant. In group I (VR group), administration of local anaesthesia will be done with wearing VR headset and in group II (control group), administration of local anaesthesia will be done without wearing VR headset. Each patient will receive VR headset during invasive dental procedure and receive no VR during the second comparable procedure on a different day. Before the administration of local anaesthesia, the child will be assessed for his/her physiological parameters using pulse oximeter at three time points: (1) once the subject is on dental chair as a baseline; (2) during local anaesthesia administration with VR and without VR; (3) after the completion of the procedure. During

the dental procedure anxiety will be assessed by using Children’s Emotional Manifestation Scale (CEMS)1 and Venham Picture Test (VPT).2 After the completion of dental procedure, a questionnaire will be given to the subject, and the results will be compared to evaluate the impact of VR on dental anxiety during local anaesthesia administration.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
5.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Healthy and cooperative 5 to 12 year old children who had no prior dental treatment experience.
  • Treatment requiring bilateral administration of local anaesthesia.

排除标准

  • Children allergic to local anaesthesia.
  • Children with special health care needs.
  • Children requiring emergency dental treatment.

结局指标

主要结局

Determined from:

时间窗: 1 week

1 Pulse Oximeter readings

时间窗: 1 week

2 Childrens Emotional Manifestation Scale Readings

时间窗: 1 week

3 Venhams Picture Test results

时间窗: 1 week

4 Facial Image Scale results

时间窗: 1 week

5 Faces Version of Modified Child Dental Anxiety Scale

时间窗: 1 week

次要结局

  • Determined from:(1 Pulse Oximeter readings)

研究者

发起方
Dr Farkhaunda Ilyas
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Farkhaunda ilyas

THE OXFORD DENTAL COLLEGE BANGALORE INDIA

研究点 (1)

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