NCT05844878

Effect of Dental Anxiety Management by Integrative Music-mindfulness Intervention Among Iraqi Adult Patients in a Karbala City Private Clinic, an RCT Study

Completed NA Last updated 14 January 2026

What this trial tests

NA trial testing Cognitive behavioral therapy (CBT) by using Distraction technique. in Dental Anxiety in 240 participants. Completed in 10 July 2024.

Timeline

15 June 2023

Primary endpoint
15 April 2024

10 July 2024

Quick facts

Lead sponsor	University of Malaya
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	240
Start date	15 June 2023
Primary completion	15 April 2024
Estimated completion	10 July 2024
Sites	2 locations across Iraq, Malaysia

Drugs / interventions tested

• Cognitive behavioral therapy (CBT) by using Distraction technique.
• Mindfulness technique by using of relaxation breathing with muscle relaxation

Conditions studied

• Dental Anxiety — all drugs for Dental Anxiety →
• Behavioral Management — all drugs for Behavioral Management →

Sponsor

University of Malaya

Who can join

17 and older, any sex, with Dental Anxiety or Behavioral Management. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Dental anxiety considered as one of the weariest problems and disturbing problems with which the individual dentist has had to fight. Dental anxiety has been a major patient's complaint which interferes with different dental treatment. Therefore, dental anxiety may have a critical impact on the deterioration of oral health. It is a problem of many patients. Excessive dental anxiety will leads to bad oral health.

It is estimated that about 36% of the world population are suffering from dental anxiety and 5- 15% of adults in developed countries suffer from severe anxiety to dental treatment. According to researchers, between 50% and 80% of adults in the United States have some degree of dental anxiety. In Saudi Arabia dental anxiety was found to be 50%. Very limited number of studies have been done in Iraq especially management of anxiety, for example in Baghdad, it was found that about 55% of study population had dental anxiety.

Because of no studies have been conducted to determine the impact of dental anxiety management in Karbala city-Iraq, thus conducting such a study is timely and much needed to improve patient care.

The goal of this clinical trial is to test the effectiveness of behavioral management technique on patients having different levels of dental anxiety, among Iraqi adult patients seeking private dental care in Karbala city.

The main question it aims to answer is: Is dental anxiety management effective in decreasing dental anxiety levels among adult Iraqi patients seeking private dental care in Karbala city? Participants will be requested to fill the self-reported questionnaire paper for anxiety levels determination \& sociodemographic factors. Researchers will use non-pharmacological behavioral therapeutic techniques including combination of cognitive behavioral therapy (distraction technique) and mindfulness therapy (relaxation breathing and muscle relaxation techniques) applied as one package. the patients with anxiety will be divided in to 2 groups; one group with applying intervention and the other group without applying intervention to see if the dental anxiety therapy is effective in decreasing dental anxiety level for anxiety patient.

This study hypothesized that there is a significant difference in the changes of dental anxiety level between managed patients and not managed patients (between group) and (within group) between pre and post managed patients after three months follow up assessment.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.