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临床试验/CTRI/2023/11/060361
CTRI/2023/11/060361招募中4 期

A Comparative Evaluation of Animated Video and Verbal Communication as a Preoperative Intervention in Reducing Dental Anxiety in Children using CD:H, Pulse rate and Facial Image Scale.

Department of Pediatric and Preventive Dentistry1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2023年12月12日最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
72
试验地点
1
主要终点
Pulse rate ,Facial Image Scale , Drawing Score(CD:H)

研究概览

简要总结

aim:To compare and evaluate the effect of visual information and verbal communication as a  pre-operative intervention in reducing level of anxiety among children aged 6-8 years old  undergoing dental treatment using CD:H, pulse rate and facial image scale.

Methodology: Children who fulfilled inclusion criteria after initial examination were divided  into two groups:

Group A- children subjected to animated video as pre-operative intervention. Group B children subjected to tell show do  as pre-operative intervention. After the  intervention on the first day after examination children in both the groups will be asked to draw  (1st drawing).

To understand the effectiveness of interventions, on the first appointment objective anxiety  signs with a pulse oximeter and subjective anxiety with Facial Image Scale will be recorded at  three stages: baseline, during treatment and post treatment. Post treatment the child will be asked  to draw (2nd drawing) which will be then analysed by a child psychologist.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator 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

  • Children Aged 6-8 years old as they were likely to have the cognitive ability and motor skills to self-report their anxiety.
  • Children without previous dental treatment experience.
  • Children with teeth which require only oral prophylaxis, pit and fissure sealants, fluoride application and minimally invasive restoration diagnosed according to ICDAS (score 2-3)
  • Children with moderate to severe anxiety as per (Modified Dental Anxiety Scale).

排除标准

  • 1.Children whose parents did not give consent for the study.
  • 2.Children who refused to draw a picture.
  • Children who are medically compromised.

结局指标

主要结局

Pulse rate ,Facial Image Scale , Drawing Score(CD:H)

时间窗: At Baseline, During procedure, After procedure

次要结局

  • Correlation between Drawing Score (CD:H) & Pulse Rate(At Baeline, During Procedure, After Procedure)

研究者

发起方
Department of Pediatric and Preventive Dentistry
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Shagorika choudhury

Dr. D.Y. Patil Deemed to be University, School of Dentistry

研究点 (1)

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