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临床试验/CTRI/2026/01/101967
CTRI/2026/01/101967招募中不适用

Effectiveness of Four Different Distraction Techniques in Management of Anxiety during Preventive Dental Treatment in Hearing Impaired Pediatric Dental Patients of age 4 -14 years of age - A Randomized Clinical Study

Dr Anshula Deshpande1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年2月5日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1

研究概览

简要总结

·       This randomized clinical study aims to evaluate and compare the effectiveness of four different distraction techniques in managing dental anxiety among hearing-impaired pediatric patients aged 4–14 years undergoing preventive dental treatment. Sixty eligible children will be randomly allocated into four groups: breathing-stimulated teddy bear (on mode), breathing-stimulated teddy bear (off mode), fidget spinner, and Picture Exchange Communication System (PECS). All participants will receive routine behavior guidance and topical fluoride application. Anxiety levels will be assessed using physiological parameters (pulse rate and oxygen saturation) and a psychological parameter (Venham’s Picture Scale) recorded before and after the procedure. The study seeks to identify a safe, non-pharmacological, and effective distraction technique to improve cooperation and reduce anxiety in hearing-impaired children during dental care.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
4.00 Year(s) 至 14.00 Year(s)(—)
性别
All

入选标准

  • Children with high caries risk
  • Children with defs, deft, DMFT and DMFS score 3 or more
  • Children who will be willing to participate in the study
  • No previous dental experience and who were aware of their surroundings
  • Children with partial or complete hearing loss
  • Children with cochlear or hearing devices will be included in study.
  • Children whose parents will give informed consent.

排除标准

  • Children allergic to fluoride agents used in the trial.
  • Children mentally challenged or disabled, and children with any type of dentofacial abnormality or syndrome were excluded from the study.
  • Children allergic to soft toys will be excluded to study.

研究者

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

Dr Anshula K Deshpande

K.M Shah Dental college & Hospital, Sumandeep Vidyapeeth, Deemed to be University

研究点 (1)

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