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临床试验/NCT06292247
NCT06292247进行中(未招募)不适用

Effectiveness of Cognitive Behavioral Therapy and Auricular Plaster Therapy on Managing Child Anxiety in Dental Office

Mansoura University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年6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
进行中(未招募)
入组人数
60
试验地点
2
主要终点
Heart Rate to detect the anxiety.

研究概览

简要总结

This study was conducted to the Effectiveness of Cognitive Behavioral Therapy and Auricular Plaster Therapy on Managing Child Anxiety in Dental Office.

详细描述

This study is to:

  1. Assess and compare the effect of cognitive behavioral therapy and auricular plaster therapy on children's anxiety in dental situations.
  2. Improve child behavior and cooperation and evaluate the parental acceptance of these behavioral management techniques.

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
None

入排标准

年龄范围
4 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Healthy children (4-7) years old, without systemic, congenital, or mental disorders nor deformities affecting the external auditory meatus.
  • Presence of dental anxiety.
  • Not requiring urgent dental treatment, with the presence of a Class I carious lesion on one of the primary molars.
  • No previous application of the guided CBT.

排除标准

  • Refusal to participate by either the children or their parents/guardians
  • Previous receiving acupuncture and moxibustion therapy.
  • Children who had taken sedative drugs at the time of the appointment.

研究组 & 干预措施

Cognitive behavioral therapy group

Experimental

CBT is based on the principle that, the way we think profoundly impacts the way we feel and behave. Therefore, learning to think differently can enable the child to feel and act differently. It is a multi-component therapy that companies cognitive (cognitive restructuring) and behavioral (relaxation and distraction) interventions to change these maladaptive cognitions, which change the emotional distress and problematic behaviors. The following techniques were used in our research in a row, unrelated play, animated video modeling, stress-ball relaxation technique, audio music therapy, and positive reinforcement. These have been used effectively to manage children's anxiety during the dental appointment.

干预措施: Auricular plaster therapy (Behavioral)

Control group (Tell show do)

Experimental

TSD is considered the cornerstone of behavior management techniques. It aims to introduce the child to the dental setting before commencing any procedure. With the TSD technique, the child should be informed about the process with a demonstration of the dental procedure using a simulator.

干预措施: Cognitive behavioral therapy (Behavioral)

Cognitive behavioral therapy group

Experimental

CBT is based on the principle that, the way we think profoundly impacts the way we feel and behave. Therefore, learning to think differently can enable the child to feel and act differently. It is a multi-component therapy that companies cognitive (cognitive restructuring) and behavioral (relaxation and distraction) interventions to change these maladaptive cognitions, which change the emotional distress and problematic behaviors. The following techniques were used in our research in a row, unrelated play, animated video modeling, stress-ball relaxation technique, audio music therapy, and positive reinforcement. These have been used effectively to manage children's anxiety during the dental appointment.

干预措施: Tell Show Do (Behavioral)

Auricular Plaster Therapy group

Experimental

APT intervention involves the application of plaster with seeds on specific points of the outer ear, known as auricular points (acupoints). According to Traditional Chinese Medicine, these points correspond to various regions of the body. Applying pressure to these points (acupressure) will stimulate and regulate energy flow throughout the body. This process is believed to restore balance and harmony within the body's system and achieve a therapeutic effect e.g. (anxiety reduction)

干预措施: Cognitive behavioral therapy (Behavioral)

Auricular Plaster Therapy group

Experimental

APT intervention involves the application of plaster with seeds on specific points of the outer ear, known as auricular points (acupoints). According to Traditional Chinese Medicine, these points correspond to various regions of the body. Applying pressure to these points (acupressure) will stimulate and regulate energy flow throughout the body. This process is believed to restore balance and harmony within the body's system and achieve a therapeutic effect e.g. (anxiety reduction)

干预措施: Tell Show Do (Behavioral)

Control group (Tell show do)

Experimental

TSD is considered the cornerstone of behavior management techniques. It aims to introduce the child to the dental setting before commencing any procedure. With the TSD technique, the child should be informed about the process with a demonstration of the dental procedure using a simulator.

干预措施: Auricular plaster therapy (Behavioral)

结局指标

主要结局

Heart Rate to detect the anxiety.

时间窗: Up to 12 weeks

It is a biological parameter and the elevation of pulse rate is an indicator for anxiety

Venham Clinical Anxiety Scale

时间窗: Up to 12 weeks

Observational anxiety scale, by choosing a number from 0 to 5 as claimed by the scales at specific time spots of the dental visit. The higher the score, the greater the level of anxiety and the poorer the cooperation of a child

RMS-Self Pictorial scale to detect the anxiety.

时间窗: Up to 12 weeks

It is a self-report scale, ranging from (1 to 5). The scale was scored by giving a value of one to very happy and five to very unhappy face. (A higher score indicates more anxiety)

次要结局

  • Parental acceptance of the behavior management technique(Up to 12 weeks)

研究者

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

Reina Abed

Principle Investigator

Mansoura University

研究点 (2)

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