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临床试验/CTRI/2019/09/021221
CTRI/2019/09/021221尚未招募4 期

Effect of visual distraction technique on pain perception and anxiety during dental treatment in 6-8 year old children

self spnsored Dr N Sridhar1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2019年9月25日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
32
试验地点
1
主要终点
2)Anxiety level in patient – Faces version of the Modified Child Dental Anxiety Scale. Time point: After the dental procedure

研究概览

简要总结

This study is a single blind randomized controlled trialthat studies the efficacy of immersive distraction techniques by using virtualreality glasses in controlling pain perception and anxiety in children agedbetween 6-8 years of age during the dental treatment. 16 patients requiringnon-invasive dental treatment will be a part of the experimental group whileanother 16 patients will be exposed to conventional behavior managementtechniques during dental treatment. The pain perception, anxiety and blood oxygensaturation of both the control and experimental group will be recorded usingWong Bakers Faces Pain Rating Scale, Faces version of the Modified Child DentalAnxiety Scale and Pulse oximeter are compared. The study will be conducted overa period of 6 months at the Department of Pedodontics and Preventive Dentistry,MCODS, Manipal, India.

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 Blinded

入排标准

年龄范围
6.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • Co-operative children who are willing to participate 2)Children in the age group of 6-8years 3)Children who scored less than 25 on the SCARED Questionnaire.
  • Children with a fair oral hygiene without any serious periodontal disease.

排除标准

  • Uncooperative children 2)Children who scored greater than 25 on the SCARED Questionnaire are known cases of systemic disease or had any previous medical history 3)Children who had a negative record of behavior 4)children who have extensive carious lesions requiring invasive procedures.
  • Children with visual and auditiory defects, 6)children with epilepsy, children that need to be sedated under general anesthesia.

结局指标

主要结局

2)Anxiety level in patient – Faces version of the Modified Child Dental Anxiety Scale. Time point: After the dental procedure

时间窗: outcomes are assessed at baseline after completion of treatment

1)Pain Perception in patient – Wong Bakers Faces Pain Rating Scale. Time point: After the dental procedure

时间窗: outcomes are assessed at baseline after completion of treatment

次要结局

  • Blood Oxygen saturation of patient - pulse oximetry. Time period: After every 10 minutes during the dental procedure.(6 months)

研究者

发起方
self spnsored Dr N Sridhar
申办方类型
Other [self funded]

研究点 (1)

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