Dental AnxietyNCT06483828
Impact of Dental Anxiety Coping Module on Children With Dental Anxiety
A study testing Dental Anxiety Coping Module in people with Dental Anxiety, run by University of Malaya at 1 site in Malaysia.
Trial summary
The aim of this study is to evaluate the impact of the Dental Anxiety Coping Module (DACM) in children with dental anxiety. The main questions to answer are: 1. Will the Dental Anxiety Coping Module has any effect on dental anxiety in primary school children based on MY-ACDAS and HRV-Biofeedback? 2. Read more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Dental Anxiety Coping Module
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMalaysia
- Study dates
- 10 Oct 2024to 4 Oct 2025
- 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 7 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Malaysian child, age 7 to 11 years old that understand basic Malay and English language.
- Children that fulfil both MY-ACDAS score 26 and above and HRV-Biofeedback of very low coherence score (incoherence).
- Children with American Society of Anaesthesiologists (ASA) I and ASA II classification.
Who cannot join
- Children requiring emergency treatment such as pain, facial cellulitis, and trauma cases.
- Child with learning disabilities, hearing, or visual impairment, developmental or intellectual disability and cognitive impairment.
- Parents/guardians who refuse to allow their child to participate in this trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Dental Anxiety Coping Module on Children With Dental Anxiety: A Randomised Controlled Trial
The aim of this study is to evaluate the impact of the Dental Anxiety Coping Module (DACM) in children with dental anxiety. The main questions to answer are:
- Will the Dental Anxiety Coping Module has any effect on dental anxiety in primary school children based on MY-ACDAS and HRV-Biofeedback?
- Is there any difference in dental anxiety between control and intervention group on baseline and post-test measured with MY-ACDAS?
- Is there any difference in dental anxiety between control and intervention group on baseline, during and post-test measured with and HRV-Biofeedback?
Read the detailed description
Dental Anxiety Coping Module (DACM) is a combination of Dental Tour and Expressive Art Therapy. Participants will be randomised into 2 groups, Control group and Intervention group (with DACM). Control group will have dental procedure without any intervention. While the Intervention group will start with dental tour where they will be shown around the dental clinic followed by Expressive Art Therapy where they will have collage and finger painting done. After DACM, participants will continue with the same dental procedure as the control group.
- Conditions
- Dental Anxiety
- Being tested
- Dental Anxiety Coping Module
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental Anxiety Coping ModuleBehavioural
Dental tour where participants will be introduced to the dental clinic setting while Expressive Art Therapy, participants will engage with activity of making collage and finger painting.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Baseline MY-ACDAS and HRV-Biofeedback assessment followed with dental procedures (dental charting and oral prophylaxis). HRV-Biofeedback will be recorded during dental procedures. Once completed, post dental procedures assessment of MY-ACDAS and HRV-Biofeedback will be recorded. |
| Intervention group | Experimental | Baseline MY-ACDAS and HRV-Biofeedback assessment followed Dental Anxiety Coping Module. The participants will continue with dental procedures (dental charting and oral prophylaxis). HRV-Biofeedback will be recorded during dental procedures. Once completed, post dental procedures assessment of MY-ACDAS and HRV-Biofeedback will be recorded. Receives: Behavioral: Dental Anxiety Coping Module |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Malaysian- Abeer Children Dental Anxiety Scale (MY-ACDAS) score
Malaysian- Abeer Children Dental Anxiety Scale (MY-ACDAS) range value from 13-39, a child is considered anxious if his/her overall score is equal or more than 26. Hence participant that score 26 and above considered having dental anxiety and will be included in the study
Measured: Before intervention and dental procedure and immediately afterwards on the same day
Secondary outcomes (1)
Changes in HRV-Biofeedback coherence
Coherence will be measured using Heart Rate Variability (HRV) biofeedback.
Measured: Before intervention and dental procedure, during dental procedure and immediately afterwards on the same day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start10 Oct 2024
- Primary completion15 Jul 2025
- Study completion4 Oct 2025
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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483828
- Sponsor's protocol ID
- DF CD 2405/0011 (P)
- Status last verified
- Jun 2024
- First submitted
- 20 Jun 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Dental Anxiety Coping Module on Children With Dental Anxiety: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06483828
- Acronym / sponsor ID
- DF CD 2405/0011 (P)
- Conditions
- Dental Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 4 Oct 2025 (actual)
- First posted
- 3 Jul 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.
The aim of this study is to evaluate the impact of the Dental Anxiety Coping Module (DACM) in children with dental anxiety. The main questions to answer are:
- Will the Dental Anxiety Coping Module has any effect on dental anxiety in primary school children based on MY-ACDAS and HRV-Biofeedback?
- Is there any difference in dental anxiety between control and intervention group on baseline and post-test measured with MY-ACDAS?
- Is there any difference in dental anxiety between control and intervention group on baseline, during and post-test measured with and HRV-Biofeedback?
Detailed description
Dental Anxiety Coping Module (DACM) is a combination of Dental Tour and Expressive Art Therapy. Participants will be randomised into 2 groups, Control group and Intervention group (with DACM). Control group will have dental procedure without any intervention. While the Intervention group will start with dental tour where they will be shown around the dental clinic followed by Expressive Art Therapy where they will have collage and finger painting done. After DACM, participants will continue with the same dental procedure as the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Baseline MY-ACDAS and HRV-Biofeedback assessment followed with dental procedures (dental charting and oral prophylaxis). HRV-Biofeedback will be recorded during dental procedures. Once completed, post dental procedures assessment of MY-ACDAS and HRV-Biofeedback will be recorded. |
| Intervention group | Experimental | Behavioral: Dental Anxiety Coping ModuleBaseline MY-ACDAS and HRV-Biofeedback assessment followed Dental Anxiety Coping Module. The participants will continue with dental procedures (dental charting and oral prophylaxis). HRV-Biofeedback will be recorded during dental procedures. Once completed, post dental procedures assessment of MY-ACDAS and HRV-Biofeedback will be recorded. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Malaysian child, age 7 to 11 years old that understand basic Malay and English language.
- Children that fulfil both MY-ACDAS score 26 and above and HRV-Biofeedback of very low coherence score (incoherence).
- Children with American Society of Anaesthesiologists (ASA) I and ASA II classification.
Key exclusion criteria (3 listed)
- Children requiring emergency treatment such as pain, facial cellulitis, and trauma cases.
- Child with learning disabilities, hearing, or visual impairment, developmental or intellectual disability and cognitive impairment.
- Parents/guardians who refuse to allow their child to participate in this trial.
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 |
|---|---|---|
| Dental Anxiety Coping ModuleDental tour where participants will be introduced to the dental clinic setting while Expressive Art Therapy, participants will engage with activity of making collage and finger painting. | Behavioural | Intervention group |
Primary outcome
Changes in Malaysian- Abeer Children Dental Anxiety Scale (MY-ACDAS) score
Time frame: Before intervention and dental procedure and immediately afterwards on the same day
Malaysian- Abeer Children Dental Anxiety Scale (MY-ACDAS) range value from 13-39, a child is considered anxious if his/her overall score is equal or more than 26. Hence participant that score 26 and above considered having dental anxiety and will be included in the study
1 secondary outcome
Changes in HRV-Biofeedback coherence
Time frame: Before intervention and dental procedure, during dental procedure and immediately afterwards on the same day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
Related trials for Dental Anxiety
Active, not recruiting
HRVB for Stress and Anxiety During Dentistry Students' Clinical Transition
Stress (Psychology), Anxiety
Recruiting
Pain Perception With Cordless Electronic Local Anesthetic Delivery System
Decayed Primary Molars
RecruitingObservational study
Bruxism, Anxiety, and Periodontal Status Among Dental Students
Bruxism, Anxiety
Recruiting
Comparative Evaluation of Intranasal Atomized Midazalom Combined With Nitrous Oxide Versus Nitrous Oxide Monotherapy
Dental Anxiety in Children, Child Behaviour
Active, not recruiting
Musical Intervention for Dental Anxiety
Dental Anxiety
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental Anxiety Coping Module in people with Dental Anxiety, run by University of Malaya at 1 site in Malaysia.
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 3 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: finished, as of the sponsor's last update on 6 May 2026. 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 Malaysia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in Malaysian- Abeer Children Dental Anxiety Scale (MY-ACDAS) score (time frame: Before intervention and dental procedure and immediately afterwards on the same day). 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 6 May 2026.