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Completed

NCT Number: NCT06483828

Impact of Dental Anxiety Coping Module on Children With Dental Anxiety

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?

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Key information

Conditions

Dental Anxiety

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universiti Malaya

Petaling Jaya, WP KUALA LUMPUR, 50603, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dental Anxiety Coping Module

Behavioral

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Changes in HRV-Biofeedback coherence

    Time frame: Before intervention and dental procedure, during dental procedure and immediately afterwards on the same day

    Coherence will be measured using Heart Rate Variability (HRV) biofeedback.

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 3, 2024
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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