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

Summary

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.

Conditions

• Dental Anxiety
• Behavioral Management

Interventions

BEHAVIORAL

Cognitive behavioral therapy (CBT) by using Distraction technique.

Distraction: The distraction in this arm will be done by hearing of soft music; the name of music that will be used is "relaxing piano music and water sounds 24/7 - ideal for stress relief". This music will be used in both the reception room and in the dental room treatment from the time-point that patient enters the reception room, and continues into the dental treatment room until the end of dental treatment when the patient exits the dental treatment room

BEHAVIORAL

Mindfulness technique by using of relaxation breathing with muscle relaxation

The mindfulness technique consist of combination of 2 procedures: 1. Relaxation breathing: this will be done during the course of dental treatment by asking the patient to do the following "Gently breathe in - hold - and let go". This procedure will be applied at the first moment when the patient sits on the dental chair before any dental treatment is done and the patient is asked to repeat this twice, each for a duration of 10 seconds. This procedure will be repeated twice; at zero time and after an interval of 16 minutes of dental treatment that extend for a 30-minute duration for each patient. 2. Muscle relaxation: this will be done by asking the patient during dental treatment to do the following "Hands - gently clench - hold - and let go". This procedure will be applied after 8 minutes from starting dental treatment, and ask the patient to do it twice for about 10 seconds. This procedure will be repeated twice; at 8 minutes and at 24 minutes of dental treatment.

Sponsors & Collaborators

• University of Malaya

  lead OTHER

Principal Investigators

• Jennifer G Doss, Professor · University of Malaya

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-06-15

Primary Completion

2024-04-15

Completion

2024-07-10

Countries

• Iraq
• Malaysia

Study Locations