Dental AnxietyNCT06292247
Effectiveness of CBT and APT on Managing Child Anxiety in Dental Office
A study testing Cognitive behavioral therapy, Auricular plaster therapy and Tell Show Do in people with Dental Anxiety, run by Mansoura University at 1 site in Egypt.
Trial summary
This study was conducted to the Effectiveness of Cognitive Behavioral Therapy and Auricular Plaster Therapy on Managing Child Anxiety in Dental Office. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Cognitive behavioral therapy, Auricular plaster therapy and Tell Show Do
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
This study is to:
- Assess and compare the effect of cognitive behavioral therapy and auricular plaster therapy on children's anxiety in dental situations.
- Improve child behavior and cooperation and evaluate the parental acceptance of these behavioral management techniques.
- Conditions
- Dental Anxiety
- Being tested
- Cognitive behavioral therapy, Auricular plaster therapy, Tell Show Do
- Keywords
- dental anxiety (DA), Cognitive behavioral therapy (CBT), Auricular Plaster Therapy (APT), Tell Show Do (TSD)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapyBehavioural
CBT aims to treat anxiety by restructuring unfavorable beliefs and controlling negative thoughts so as to reduce dental anxiety.
Auricular plaster therapyBehavioural
Also called acupressure
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 DoBehavioural
Also called TSD
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) Receives: 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. Receives: Behavioral: Cognitive behavioral therapy; Behavioral: Auricular plaster therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
Measured: Up to 12 weeks
Secondary outcomes (1)
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).
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start1 Jun 2023
- Primary completion23 Oct 2023
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1 (CBT) Group 2 (APT) Group3 (control TSD)
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reina Abed, Mansoura University
- Investigators
- Reina N Abed, Master, Principal investigator, Mansoura UniversitySalwa M Awad, Prof, Study director, Prof. of Pediatric Dentistry and Dental Public Health Faculty of Dentistry Mansoura UniversityAhmad H Wahba, PhD, Study director, Prof. of Pediatric Dentistry and Dental Public Health Faculty of Dentistry Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06292247
- Sponsor's protocol ID
- A0503023
- Status last verified
- Mar 2024
- First submitted
- 13 Feb 2024
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Cognitive Behavioral Therapy and Auricular Plaster Therapy on Managing Child Anxiety in Dental Office
- ClinicalTrials.gov ID
- NCT06292247
- Acronym / sponsor ID
- A0503023
- Conditions
- Dental Anxiety
- Keywords
- dental anxiety (DA), Cognitive behavioral therapy (CBT), Auricular Plaster Therapy (APT), Tell Show Do (TSD)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 23 Oct 2023 (actual)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was conducted to the Effectiveness of Cognitive Behavioral Therapy and Auricular Plaster Therapy on Managing Child Anxiety in Dental Office.
Detailed description
This study is to:
- Assess and compare the effect of cognitive behavioral therapy and auricular plaster therapy on children's anxiety in dental situations.
- Improve child behavior and cooperation and evaluate the parental acceptance of these behavioral management techniques.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Group 1 (CBT) Group 2 (APT) Group3 (control TSD)
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioral therapy group | Experimental | Behavioral: Auricular plaster therapy, Behavioral: Tell Show DoCBT 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. |
| Auricular Plaster Therapy group | Experimental | Behavioral: Cognitive behavioral therapy, Behavioral: Tell Show DoAPT 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) |
| Control group (Tell show do) | Experimental | Behavioral: Cognitive behavioral therapy, Behavioral: Auricular plaster therapyTSD 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. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioral therapyCBT aims to treat anxiety by restructuring unfavorable beliefs and controlling negative thoughts so as to reduce dental anxiety. | Behavioural | Auricular Plaster Therapy group, Control group (Tell show do) |
| Auricular plaster therapyAlso: acupressureAPT 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) | Behavioural | Cognitive behavioral therapy group, Control group (Tell show do) |
| Tell Show DoAlso: TSDTSD 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. | Behavioural | Auricular Plaster Therapy group, Cognitive behavioral therapy group |
Primary outcome
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
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
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)
1 secondary outcome
Parental acceptance of the behavior management technique
Time frame: Up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Individual participant dataSharing planned: Yes. Study protocol to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reina N Abed, Master principal investigator
Mansoura University
Salwa M Awad, Prof study director
Prof. of Pediatric Dentistry and Dental Public Health Faculty of Dentistry Mansoura University
Ahmad H Wahba, PhD study director
Prof. of Pediatric Dentistry and Dental Public Health Faculty of Dentistry Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy, Auricular plaster therapy and Tell Show Do in people with Dental Anxiety, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venham Clinical Anxiety Scale (time frame: Up to 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.