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

NCT06292247 | Active Not Recruiting

• 1 other identifier: A0503023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dental Anxiety

Keywords

dental anxiety (DA); Cognitive behavioral therapy (CBT); Auricular Plaster Therapy (APT); Tell Show Do (TSD)

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Parental acceptance of the behavior management technique

  Up to 12 weeks

Study Arms (3)

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.

Behavioral: Auricular plaster therapy; Behavioral: Tell Show Do

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)

Behavioral: Cognitive behavioral therapy; Behavioral: Tell Show Do

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.

Behavioral: Cognitive behavioral therapy; Behavioral: Auricular plaster therapy

Interventions

Cognitive behavioral therapy BEHAVIORAL

CBT aims to treat anxiety by restructuring unfavorable beliefs and controlling negative thoughts so as to reduce dental anxiety.

Auricular Plaster Therapy group; Control group (Tell show do)

Auricular plaster therapy BEHAVIORAL

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)

Also known as: acupressure

Cognitive behavioral therapy group; Control group (Tell show do)

Tell Show Do BEHAVIORAL

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.

Also known as: TSD

Auricular Plaster Therapy group; Cognitive behavioral therapy group

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of dentistry

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

MeSH Terms

Interventions

Cognitive Behavioral Therapy; Acupressure

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Reina N Abed, Master

  Mansoura University

  PRINCIPAL INVESTIGATOR

• Salwa M Awad, Prof

  Prof. of Pediatric Dentistry and Dental Public Health Faculty of Dentistry Mansoura University

  STUDY DIRECTOR

• Ahmad H Wahba, PhD

  Prof. of Pediatric Dentistry and Dental Public Health Faculty of Dentistry Mansoura University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Group 1 (CBT) Group 2 (APT) Group3 (control TSD)

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: March 5, 2024
• Study Start: June 1, 2023
• Primary Completion: October 23, 2023
• Study Completion: May 1, 2024
• Last Updated: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Within 6 months
• Access Criteria: For anyone

Locations

EG (1)