跳至主要内容
临床试验/CTRI/2023/05/053162
CTRI/2023/05/053162尚未招募不适用

Comparative evaluation of pain and dental anxiety with the use of virtual reality distraction and conventional behaviour management in children

Yashaswini B P1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年2月6日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Reduced dental anxiety

研究概览

简要总结

This trial is a randomised controlled, double blinded,parallel group trial evaluating pain perception, pulse rate, oxygen saturation,salivary pH as a measure of dental anxiety. Written informed consent fromparents /caretakers would be taken. Children of 6 to 10 years of age would berecruited from the patients visiting the Department of Pediatric and PreventiveDentistry of Dental college in Bangalore where ethical clearance has beenobtained. Pulse rate and oxygen saturation are assessed using a pulse oximeterat three intervals, preoperatively, intraoperative and postoperatively.Salivary pH will be assessed from the patient’s saliva sample collected at twointervals, preoperatively and postoperatively, by a digital pH meter. Thechildren will be randomly allocated into two groups, VR group, who will receiverestorative treatment while being subjected to VR videos on the eyeglasses andthe other group will receive restorative treatment while distracted by means ofcommunication. The primary outcome would be reduced dental anxiety andsecondary outcome would be increased coping towards dental treatment.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
6.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • •Children with no prior history of dental treatment.
  • •Subjects and parents willing to give informed consent.
  • •Subjects requiring restorative treatment.
  • •Subjects scoring 3 or 4 on the Frankl’s Behaviour Rating Scale.

排除标准

  • •Subjects with physical/mental/developmental disorders.
  • •Subjects with Claustro-Phobia and Epilepsy.
  • •Subjects with Salivary Gland Disorders.
  • •Subjects that require local anesthesia administration for restoration.
  • •Subjects scoring 1 or 2 on the Frankl’s Behaviour Rating Scale.

结局指标

主要结局

Reduced dental anxiety

时间窗: 1 hour

次要结局

  • Better coping to get dental treatment(1 month)

研究者

发起方
Yashaswini B P
申办方类型
Other [self]

研究点 (1)

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