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

NCT05844878 | Completed

• 1 other identifier: DF CO2302/0008 (P)
• Study Type: interventional
• Target: 240
• Locations: 2 countries
• Sites: 2

Brief 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

Keywords

dental anxiety; impact; behavioral management; adult; Iraqi patients

Outcome Measures

Primary Outcomes (1)

• The dental anxiety measured by using modified dental anxiety scale MDAS

  MDAS will be used to determine anxiety levels which will be divided as the following; * No anxiety = (5 point) * Low level of anxiety = (6 - 10 point) * Moderate level of anxiety = (11 - 15 point) * High level of anxiety = (16 - 25 point). MDAS consists of five questions where by each of question has five scores, ranging from 'not anxious', 'slightly anxious', 'fairly anxious', 'very anxious' to 'extremely anxious,' in ascending order from 1 to 5.

  Post intervention measurement of MDAS after 3 months from applying the intervention

Secondary Outcomes (1)

• Dental anxiety management

  Post intervention measurement of MDAS after 3 months from applying the intervention.

Study Arms (2)

Dental anxiety management intervention group

EXPERIMENTAL

in this arm; the patients will under go combination of 2 anxiety management techniques by using of behavioral therapeutic management including; Cognitive behavioral therapy (CBT) by using Distraction technique, and Mindfulness technique by using of relaxation breathing with muscle relaxation, during dental treatment through 30 minutes. then after 3 months those patients will be followed up for re measurement of anxiety level by using the same modified dental anxiety scale questionnaire.

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

control group

NO INTERVENTION

in this arm; the patients will under go dental treatment for the same duration as the intervention arm treatment, but without applying the anxiety management techniques. Subsequently, each patient will be followed up after 3 months, similar to the intervention group.

Interventions

Cognitive behavioral therapy (CBT) by using Distraction technique. BEHAVIORAL

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

Dental anxiety management intervention group

Mindfulness technique by using of relaxation breathing with muscle relaxation BEHAVIORAL

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.

Dental anxiety management intervention group

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with self-reported anxiety score MDAS from (6 - 25) in phase one.
• All patients who are scheduled to undergo dental treatment with a planned maximum treatment length of 30 minutes are eligible to participate in the study.
• Patients accept to undergo management technique for their dental anxiety.

You may not qualify if:

• Patients who have systemic diseases other than diabetes, hypertension, heart problem, and hyperthyroidism.
• Patients that did not complete the MDAS questionnaire.
• Patients that did not attend any follow up.
• Patients that refuse to complete and follow the study requirement.

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (2)

Dental Private Clinic

Karbala, Hay Al-amel, 5600, Iraq

Location

UM University

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

Location

MeSH Terms

Conditions

Tooth, Impacted

Interventions

Cognitive Behavioral Therapy; Muscle Relaxation

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Muscle Contraction; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jennifer G Doss, Professor

  University of Malaya

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: May 6, 2023
• Study Start: June 15, 2023
• Primary Completion: April 15, 2024
• Study Completion: July 10, 2024
• Last Updated: January 14, 2026

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1); IR (1)