Skip to content

Impact of Dental Anxiety Coping Module on Children With Dental Anxiety

The Impact of Dental Anxiety Coping Module on Children With Dental Anxiety: A Randomised Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06483828
Enrollment
60
Registered
2024-07-03
Start date
2024-10-10
Completion date
2025-10-04
Last updated
2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Anxiety

Brief 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. Is there any difference in dental anxiety between control and intervention group on baseline and post-test measured with MY-ACDAS? 3. 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.

Interventions

BEHAVIORALDental Anxiety Coping Module

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.

Sponsors

University of Malaya
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
7 Years to 11 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Changes in Malaysian- Abeer Children Dental Anxiety Scale (MY-ACDAS) scoreBefore intervention and dental procedure and immediately afterwards on the same dayMalaysian- 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

Secondary

MeasureTime frameDescription
Changes in HRV-Biofeedback coherenceBefore intervention and dental procedure, during dental procedure and immediately afterwards on the same dayCoherence will be measured using Heart Rate Variability (HRV) biofeedback.

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026