Impact of Dental Anxiety Coping Module on Children With Dental Anxiety

NCT06483828 | Completed

• 1 other identifier: DF CD 2405/0011 (P)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Dental Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes in HRV-Biofeedback coherence

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

Study Arms (2)

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.

Behavioral: Dental Anxiety Coping Module

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Universiti Malaya

Petaling Jaya, WP KUALA LUMPUR, 50603, Malaysia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: July 3, 2024
• Study Start: October 10, 2024
• Primary Completion: July 15, 2025
• Study Completion: October 4, 2025
• Last Updated: May 6, 2026

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)