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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Dental Anxiety
• Intervention / Treatment: Behavioral: Auricular plaster therapy; Behavioral: Tell Show Do; Behavioral: Cognitive behavioral therapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 35511
      • Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive behavioral therapy group; 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.	Behavioral: 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); Other Names: acupressure; Behavioral: 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.; Other Names: TSD
Experimental: Auricular Plaster Therapy group; 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)	Behavioral: 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.; Other Names: TSD; Behavioral: Cognitive behavioral therapy; CBT aims to treat anxiety by restructuring unfavorable beliefs and controlling negative thoughts so as to reduce dental anxiety.
Experimental: Control group (Tell show do); 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.	Behavioral: 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); Other Names: acupressure; Behavioral: Cognitive behavioral therapy; CBT aims to treat anxiety by restructuring unfavorable beliefs and controlling negative thoughts so as to reduce dental anxiety.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Director: Salwa M Awad, Prof, Prof. of Pediatric Dentistry and Dental Public Health Faculty of Dentistry Mansoura University; Principal Investigator: Reina N Abed, Master, Mansoura University; Study Director: Ahmad H Wahba, PhD, Prof. of Pediatric Dentistry and Dental Public Health Faculty of Dentistry Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): October 23, 2023
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: February 13, 2024
• First Submitted That Met QC Criteria: March 3, 2024
• First Posted (Actual): March 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Cognitive behavioral therapy (CBT); dental anxiety (DA); Auricular Plaster Therapy (APT); Tell Show Do (TSD)
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: A0503023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study protocol to other researchers
• IPD Sharing Time Frame: Within 6 months
• IPD Sharing Access Criteria: For anyone
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No