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临床试验/CTRI/2024/05/068067
CTRI/2024/05/068067招募中4 期

Comparative Evaluation of the Effect of Visual Stimulation and Auditory Stimulation on Dental Anxiety in Children with Special Health Care Needs

ITS Dental College Hospital and Research Centre1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年6月16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
34
试验地点
1
主要终点
Measurement Of Behavioural Distress, Sensory Discomfort, Physiological Distress

研究概览

简要总结

In the clinical setting of the Department of Pediatric and Preventive Dentistry at I.T.S. Dental College, Greater Noida, in children with Mild Intellectual Developmental Disorders (Mild IDD) in the age group of 6 to 12 years. To ensure a conducive and child-friendly environment, we will modify a designated room, incorporating a carefully selected colour theme and child-appropriate depictions. The room will be illuminated with dim lighting, while Lavender Essential Oil will be diffused using an electric vaporizer to provide olfactory stimulation. Additionally, we will employ wraps to offer a comforting hugging effect. The initial appointment will focus on visual stimulation, integrating a bubble tube, as reported by the parents. In the subsequent session, we will introduce auditory stimulation through instrumental music.

The preventive dental treatment will be administered in two sequential appointments. The first session will involve the application of Pit and Fissure sealant on the right side, followed by a similar procedure on the left side during the second appointment. The time interval between these two appointments will be at least 15 days.

The objective of this study is to assess outcomes such as behavioural distress, sensory discomfort, and physiological distress in these young patients, thereby enhancing our understanding of providing optimal dental care for children with Mild IDD.

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
6.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Age Group- 6 to 12 years Children with Mild Intellectual Developmental disorders (IDDs) Parents giving consent for the study.

排除标准

  • Children with Auditory Impairment Children with Visual Impairment Parents not willing to participate in the study.

结局指标

主要结局

Measurement Of Behavioural Distress, Sensory Discomfort, Physiological Distress

时间窗: At Baseline | After Treatment

次要结局

未报告次要终点

研究者

发起方
ITS Dental College Hospital and Research Centre
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Ananya Sharma

I T S Dental College Hospital & Research Centre

研究点 (1)

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