跳至主要内容
临床试验/NCT06698523
NCT06698523已完成不适用

Evaluation of Bubble-Blower Exercise and Pin-Wheel Exercise on Dental Anxiety in Children: A Randomized Controlled Trial

Ain Shams University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Heart rate to assess child's dental anxiety

研究概览

简要总结

in this study investigator evaluate the effectiveness of breathing exercise using two different play toys in reducing dental anxiety.

详细描述

bubble blower and pin wheel are used to facilitate breathing exercise and to reduce dental anxiety hence more cooperation of participants during dental treatment

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •children that had been introduced to dental setting without receiving any dental treatment
  • •According to Corah 's dental anxiety scale children classified with score 19 or more
  • •No learning disability or psychological disorder or parental anxiety

排除标准

  • •children in emergency visit
  • •Allergy to anesthetic drugs
  • •Use of analgesic before treatment
  • •Teeth with necrotic pulp
  • •children whose parents refused to sign informed consent

研究组 & 干预措施

Pin-wheel

Experimental

breathing exercise technique using Pin-wheel

干预措施: Deep breathing (Behavioral)

Tell- show-Do

No Intervention

Control group

Bubble-blower

Experimental

breathing exercise technique using bubble-blower

干预措施: Breathing exercise (Behavioral)

结局指标

主要结局

Heart rate to assess child's dental anxiety

时间窗: during dental treatment after local anesthetic injection. Heart rate is measured in beats/min measured twice, first before any dental treatment and measured a second time after 7-10 minutes after injection of local anesthesia

correlating participants anxiety to heart rate the higher the heart rate indicating the higher the anxiety level of patients

Venham picture test used to assess dental anxiety

时间窗: during dental treatment recorded before any treatment is done and after five minutes of injection of local anesthesia

score 0-8, it is an eight cards photos that are shown to children if child chooses the more anxious child in picture this is recorded as a score, the higher the score the more anxious the participants.

Salivary Alpha amylase

时间窗: before any dental treatment is done and 7-10 minutes after injection of local anesthesia

collecting saliva sample for assessment of alpha amylase by ELISA test, saliva collected twice before and after injection of local anesthesia and correlating concentration to dental anxiety the higher the concentration of alpha amylase indicates more anxious children

次要结局

  • Innovation of a new protocol in behavior management prior to painful dental procedure(during dental treatment that will take 15-30 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Passant Mohamed Ibrahim Attia Elbahy

Principal Investigator

Ain Shams University

研究点 (1)

Loading locations...

相似试验