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

March 6, 2024 updated by: Reina Abed, Mansoura University

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Heart Rate to detect the anxiety.
Time Frame: Up to 12 weeks
It is a biological parameter and the elevation of pulse rate is an indicator for anxiety
Up to 12 weeks
Venham Clinical Anxiety Scale
Time Frame: 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
Up to 12 weeks
RMS-Self Pictorial scale to detect the anxiety.
Time Frame: 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)
Up to 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Parental acceptance of the behavior management technique
Time Frame: Up to 12 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mansoura University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 23, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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