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临床试验/CTRI/2025/03/083441
CTRI/2025/03/083441尚未招募不适用

Influence of parental presence on childrens behaviour in dental operatory.

Department of Pediatric and Preventive dentistry1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2025年4月7日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
74
试验地点
1
主要终点
anxiety and behaviour of children.

研究概览

简要总结

Aim and objective: Successfully managing the behavioural resistance of preschool children is an essential component of providing high-quality pediatric dental care. According to the literature, the presence of parents during treatment significantly impacts the behaviour of children. The current study aims to evaluate the impact of parental presence on children’s behaviour and anxiety in dental operatory.

Methodology: The study was conducted on 74 children of 4-6 years undergoing various dental procedures. Children were selected according to inclusion criteria and randomly divided into two subgroups. Group I included those whose parents were present; while Group II included children whose parents were absent during the treatment procedure. The behaviour of children was recorded using the Frankl behaviour rating scale and facial image scale (FIS) and the highest heartbeat was recorded using a finger pulse oximeter at the time of the procedure.

研究设计

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

入排标准

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

入选标准

  • Children of age 4yrs to 6yrs requiring alike treatment sessions.
  • Children undergoing treatment with local anesthesia.
  • Lack of any systemic disease or any psychiatric disorder (ADHD, phobia, etc)
  • Children without any history of previous hospitalization.
  • Lack of any psycho-pathological familial history (including the addiction of a parent, divorce, familial violence, and child abuse).

排除标准

  • Children with psychological development delays and learning disabilities.
  • Children who needed emergency dental treatments.
  • Children whose parents did not provide their consent for the study.

结局指标

主要结局

anxiety and behaviour of children.

时间窗: baseline

increased or decreased heart rate associated with dental anxiety.

时间窗: baseline

次要结局

  • parental satisfaction(success of treatment)

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

Priya Gore

Padmashree Dr. D.Y. Patil Dental College and Hospital Navi Mumbai

研究点 (1)

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