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

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?

Study Overview

• Status: Completed
• Conditions: Dental Anxiety
• Intervention / Treatment: Behavioral: Dental Anxiety Coping Module

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • WP KUALA LUMPUR
    • Petaling Jaya, WP KUALA LUMPUR, Malaysia, 50603
      • Universiti Malaya

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; 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.
Experimental: Intervention group; 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.	Behavioral: Dental 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Before intervention and dental procedure and immediately afterwards on the same day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in HRV-Biofeedback coherence	Coherence will be measured using Heart Rate Variability (HRV) biofeedback.	Before intervention and dental procedure, during dental procedure and immediately afterwards on the same day

Collaborators and Investigators

• Sponsor: University of Malaya

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2024
• Primary Completion (Actual): July 15, 2025
• Study Completion (Actual): October 4, 2025

Study Registration Dates

• First Submitted: June 20, 2024
• First Submitted That Met QC Criteria: June 27, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: DF CD 2405/0011 (P)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No