Impact of Dental Anxiety Coping Module on Children with Dental Anxiety

Not Applicable

Recruiting

• Conditions: Dental Anxiety
• Interventions: Behavioral: Dental Anxiety Coping Module

• Registration Number: NCT06483828
• Lead Sponsor: University of Malaya

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.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-20
• Study First Submitted QC: 2024-06-27
• Study First Posted: 2024-07-03
• Study Start: 2024-10-10
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14
• Primary Completion: 2025-03-04
• Study Completion: 2025-08-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Dental Anxiety Coping Module	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.

Primary Outcome Measures

Name	Time	Method
Changes in Malaysian- Abeer Children Dental Anxiety Scale (MY-ACDAS) score	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 Outcome Measures

Name	Time	Method
Changes in HRV-Biofeedback coherence	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.

Trial Locations

Locations (1)

Universiti Malaya; 🇲🇾 Petaling Jaya, Wp Kuala Lumpur, Malaysia