Effectiveness of CBT and APT on Managing Child Anxiety in Dental Office

Dental Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06292247
• Other study ID #: A0503023
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: March 2024
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: May 1, 2024
• Est. primary completion date: October 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 7 Years

Eligibility

Inclusion Criteria:

1. Healthy children (4-7) years old, without systemic, congenital, or mental disorders nor deformities affecting the external auditory meatus.

2. Presence of dental anxiety.

3. Not requiring urgent dental treatment, with the presence of a Class I carious lesion on one of the primary molars.

4. No previous application of the guided CBT.

Exclusion Criteria:

1. Refusal to participate by either the children or their parents/guardians

2. Previous receiving acupuncture and moxibustion therapy.

3. Children who had taken sedative drugs at the time of the appointment.

Related Conditions & MeSH terms

• Anxiety Disorders
• Dental Anxiety

Intervention

Behavioral:
• Cognitive behavioral therapy
CBT aims to treat anxiety by restructuring unfavorable beliefs and controlling negative thoughts so as to reduce dental anxiety.
• Auricular plaster therapy
APT involves the application of plaster with seeds on specific points of the outer ear, known as auricular points (acupoints). This process is believed to restore balance and harmony within the body's system and achieve a therapeutic effect (e.g. reduce anxiety)
• Tell Show Do
TSD is composed of 3 phases. The Tell phase involves an age-appropriate explanation of the procedure. The Show phase is used to demonstrate a procedure up to the point where the instrument is performed. The Do phase is then initiated, and the treatment is performed.

Locations

Country	Name	City	State
Egypt	Faculty of dentistry	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Venham Clinical Anxiety Scale	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	Up to 12 weeks
Primary	Heart Rate to detect the anxiety.	It is a biological parameter and the elevation of pulse rate is an indicator for anxiety	Up to 12 weeks
Primary	RMS-Self Pictorial scale to detect the anxiety.	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)	Up to 12 weeks
Secondary	Parental acceptance of the behavior management technique	The parental acceptance rating will be determined on a five-point Likert-type scale ranging from 1 (highly acceptable) to 5 (highly unacceptable).	Up to 12 weeks