Dental AnxietyNCT05844878
Effect of Dental Anxiety Management by Integrative Music-mindfulness Intervention Among Iraqi Adult Patients in a Karbala City Private Clinic, an RCT Study
A study testing Distraction technique by using music therapy. and Mindfulness technique by using of relaxation breathing with muscle relaxation in people with Dental Anxiety and Behavioral Management, run by University of Malaya at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Dental Anxiety, Behavioral Management
- What is being tested?
- Distraction technique by using music therapy. and Mindfulness technique by using of relaxation breathing with muscle relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Feb 2023to 10 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Inclusion Criteria: Researchers will include patients who fulfill these criteria:
- 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.
Exclusion Criteria: Researchers will exclude the following patients:
- 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. Severe psychiatric disorders, cognitive impairment that prevents participation in mindfulness, hearing impairment that prevents music intervention, and current use of an anxiolytic medication.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Study Protocol for RCT of Integrative Music-mindfulness Intervention for Treating of Dental Anxiety Among Iraqi Adult Patients Seeking Private Dental Care in Karbala City.
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.
Read more
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 music 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.
Read the detailed description
Study design:
This study is a non-pharmacological parallel randomized control trial study design (RCT). It includes a self-administered questionnaire modified dental anxiety scale (MDAS: modified dental anxiety scale), socio demographic factors questionnaire, which are filled by the patients for identifying eligible participants which is done in the first visit to the private dental clinic. Then after collection of all patients data, randomized allocation of the participants will be done to the patients with different levels of anxiety (low, moderate, and high level) into two groups; intervention group (integrative music-mindfulness management which are applied as one package) and control group (without intervention) with allocation ratio of 1:1 for each level to each group.
After three months from the application of the dental anxiety management, these two groups of patients will be asked to come to the same clinic. In addition, they will be requested to fill the Modified Dental Anxiety Scale (MDAS) form again before any dental treatment. These steps will be applied to determine if there are any differences in their dental anxiety levels pre and post application of intervention and to assess if the intervention management is successful for this period. Furthermore, researchers will see the effect of management techniques on patients with and without systemic diseases and compare between them to see if there are any significant differences of the intervention on patients with and without systemic diseases. This is because some patients do not seek dental care due to anxiety from complications of systemic diseases and not due to anxiety from dental treatment procedures.
Participants:
The participants for this study design consists of Iraqi adult patients, aged 17 year and above, of both genders, who have self-reported as having dental anxiety, seeking Iraqi private dental care in Karbala city for various treatment modalities with using of dental anesthesia injection, who attending private dental clinic which is located in an area named "Hay Al-amel" in the center of Karbala city.
How participants and clinic recruited to this study? This study will be applied in one private dental clinics. This private dental clinic is recruited to this study by providing all requirement needed for this study as the following;
- This clinic consist of a reception room, dental treatment room, and third room suitable for patients' interview.
- This clinic will provide all necessary copies of; participant information sheet (PIS), consent form, MDAS questionnaire papers for pre \& post intervention treatment, sociodemographic questionnaire papers.
- Provide microphone in both reception room and dental treatment room for hearing of soft music during dental anxiety management.
In this private clinic the patients will be treated by the same dentist that have a good experience for about 22 years. All those patients coming to this clinic were received by the same secretariat person.
The participant after acceptance to be part of this study by reading and assigning the consent form and PIS; will undergo and follow the following procedures which include:
- Each participant come to dental clinic in the first visit will be requested to fill the self-reported questionnaire paper for MDAS \& sociodemographic factors, before any dental treatment.
- Dental treatment according to the patients need.
- After completing data collection of all participants, then inviting the anxiety patients recruited with different levels of dental anxiety for next treatment appointment (as a second visit appointment) in the same private dental clinic by the same dentist for applying dental treatment for both arms and applying the intervention for intervention arm. The date of this visit should be recorded and fixed specifically for each patient.
- Researchers will be going to use RCT study design to investigate the efficacy of the combination of integrative music-mindfulness intervention which applied as one package for managing dental anxiety.
- Then; each patient within the intervention arm and within the control arm will be invited for dental treatment (as a third visit appointment) and follow up after three months specifically for each patient from the date that recorded in previous patient's visit. All those patients in this visit will be recruited and invited to this visit to the same private dental clinic and treated by the same dentist. All those patients will be requested by the same secretariat person to fill a new MDAS questionnaire paper in the reception room before any dental treatment (this is the second MDAS questionnaire paper that should be filled by the same patients). Hence in this visit it is very important that those patients should be come for this visit for completing dental treatment or new dental treatment and not only for follow up to fill the MDAS questioner paper, to prevent any bias. Because the psychology and feeling of the patients are not the same when the patient go to the dentist clinic for dental treatment or go to the dentist clinic to fill MDAS questionnaire paper without any dental treatment.
Intervention: dental anxiety management (integrative music-mindfulness technique):
Researchers will be going to use (RCT) to investigate the efficacy of the integrative music-mindfulness intervention for managing dental anxiety. This combination intervention technique is described in the following sections.
- Music therapy:
- Distraction: is one of the useful techniques of diverting the patient's attention from what may be perceived as an unpleasant procedure. This enables decreased perception of unpleasantness and averting negative or avoidance behavior. The distraction in this study 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.
- Mindfulness technique:
- Diaphragmatic or relaxation breathing: Diaphragmatic or relaxation breathing in this study 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 relaxation breathing procedure will be repeated twice; at zero time of treatment and after an interval of 16 minutes of dental treatment that extend for a 30-minute duration for each patient. (That mean applied at 0 minute, then at 16 minutes).
- Progressive muscle relaxation: The Progressive muscle relaxation in this study will 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 (which mean after 8 minutes from applying the relaxation breathing technique), and ask the patient to do it twice for about 10 seconds. All these procedures will be repeated twice; at 8 minutes of treatment and at 24 minutes of dental treatment that extend for a duration of 30 minutes for each patient. (That means it is applied at the 8 minute, then at the 24 minute)
The anxiety management intervention and treatment procedure used in this study will be applied for 30 minutes for each dentally anxious patient. This is done for standardization purpose. Follow up dental appointments for these patients will be after three months.
In the control group, Researchers will carry out 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.
- Conditions
- Dental Anxiety, Behavioral Management
- Being tested
- Distraction technique by using music therapy., Mindfulness technique by using of relaxation breathing with muscle relaxation
- Keywords
- dental anxiety, behavioral management, adult, Iraqi patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distraction technique by using music therapy.Behavioural
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
Mindfulness technique by using of relaxation breathing with muscle relaxationBehavioural
The mindfulness technique consist of combination of 2 procedures:
- 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.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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; music therapy 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. Receives: Behavioral: Distraction technique by using music therapy.; 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post intervention measurement of MDAS after 3 months from applying the intervention
Secondary outcomes (1)
Dental anxiety management
by using modified dental anxiety scale MDAS to determine anxiety levels which will be divided as the following;
- Low level of anxiety = (6 - 10 point)
- Moderate level of anxiety = (11 - 15 point)
- High level of anxiety = (16 - 25 point).
- Sociodemographic factors (such as age, gender, and education).
- Oral hygiene status (DMFT and OHS-I).
- systemic health conditions (diabetes, hypertension and cardiovascular disease) the minimum MDAS score mean less anxiety level, and if the MDAS score for the same patient is less in post intervention measurement than pre intervention measurement; that is mean the management technique is successful to decrease the anxiety level for this patient.
Measured: Post intervention measurement of MDAS after 3 months from applying the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start15 Feb 2023
- Primary completion15 Apr 2024
- Study completion10 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer G Doss, Professor, Study chair, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844878
- Sponsor's protocol ID
- DF CO2302/0008 (P)
- Status last verified
- Jul 2024
- First submitted
- 13 Apr 2023
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data (demographics, baseline anxiety, outcomes) and statistical code (SPSS syntax) are available from the corresponding author upon reasonable request. Access is limited to academic use under a data-sharing agreement, in line with institutional and ethical guidelines to ensure participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Protocol for RCT of Integrative Music-mindfulness Intervention for Treating of Dental Anxiety Among Iraqi Adult Patients Seeking Private Dental Care in Karbala City.
- ClinicalTrials.gov ID
- NCT05844878
- Acronym / sponsor ID
- DF CO2302/0008 (P)
- Conditions
- Dental Anxiety, Behavioral Management
- Keywords
- dental anxiety, behavioral management, adult, Iraqi patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 music 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.
Detailed description
Study design:
This study is a non-pharmacological parallel randomized control trial study design (RCT). It includes a self-administered questionnaire modified dental anxiety scale (MDAS: modified dental anxiety scale), socio demographic factors questionnaire, which are filled by the patients for identifying eligible participants which is done in the first visit to the private dental clinic. Then after collection of all patients data, randomized allocation of the participants will be done to the patients with different levels of anxiety (low, moderate, and high level) into two groups; intervention group (integrative music-mindfulness management which are applied as one package) and control group (without intervention) with allocation ratio of 1:1 for each level to each group.
After three months from the application of the dental anxiety management, these two groups of patients will be asked to come to the same clinic. In addition, they will be requested to fill the Modified Dental Anxiety Scale (MDAS) form again before any dental treatment. These steps will be applied to determine if there are any differences in their dental anxiety levels pre and post application of intervention and to assess if the intervention management is successful for this period. Furthermore, researchers will see the effect of management techniques on patients with and without systemic diseases and compare between them to see if there are any significant differences of the intervention on patients with and without systemic diseases. This is because some patients do not seek dental care due to anxiety from complications of systemic diseases and not due to anxiety from dental treatment procedures.
Participants:
The participants for this study design consists of Iraqi adult patients, aged 17 year and above, of both genders, who have self-reported as having dental anxiety, seeking Iraqi private dental care in Karbala city for various treatment modalities with using of dental anesthesia injection, who attending private dental clinic which is located in an area named "Hay Al-amel" in the center of Karbala city.
How participants and clinic recruited to this study? This study will be applied in one private dental clinics. This private dental clinic is recruited to this study by providing all requirement needed for this study as the following;
- This clinic consist of a reception room, dental treatment room, and third room suitable for patients' interview.
- This clinic will provide all necessary copies of; participant information sheet (PIS), consent form, MDAS questionnaire papers for pre \& post intervention treatment, sociodemographic questionnaire papers.
- Provide microphone in both reception room and dental treatment room for hearing of soft music during dental anxiety management.
In this private clinic the patients will be treated by the same dentist that have a good experience for about 22 years. All those patients coming to this clinic were received by the same secretariat person.
The participant after acceptance to be part of this study by reading and assigning the consent form and PIS; will undergo and follow the following procedures which include:
- Each participant come to dental clinic in the first visit will be requested to fill the self-reported questionnaire paper for MDAS \& sociodemographic factors, before any dental treatment.
- Dental treatment according to the patients need.
- After completing data collection of all participants, then inviting the anxiety patients recruited with different levels of dental anxiety for next treatment appointment (as a second visit appointment) in the same private dental clinic by the same dentist for applying dental treatment for both arms and applying the intervention for intervention arm. The date of this visit should be recorded and fixed specifically for each patient.
- Researchers will be going to use RCT study design to investigate the efficacy of the combination of integrative music-mindfulness intervention which applied as one package for managing dental anxiety.
- Then; each patient within the intervention arm and within the control arm will be invited for dental treatment (as a third visit appointment) and follow up after three months specifically for each patient from the date that recorded in previous patient's visit. All those patients in this visit will be recruited and invited to this visit to the same private dental clinic and treated by the same dentist. All those patients will be requested by the same secretariat person to fill a new MDAS questionnaire paper in the reception room before any dental treatment (this is the second MDAS questionnaire paper that should be filled by the same patients). Hence in this visit it is very important that those patients should be come for this visit for completing dental treatment or new dental treatment and not only for follow up to fill the MDAS questioner paper, to prevent any bias. Because the psychology and feeling of the patients are not the same when the patient go to the dentist clinic for dental treatment or go to the dentist clinic to fill MDAS questionnaire paper without any dental treatment.
Intervention: dental anxiety management (integrative music-mindfulness technique):
Researchers will be going to use (RCT) to investigate the efficacy of the integrative music-mindfulness intervention for managing dental anxiety. This combination intervention technique is described in the following sections.
- Music therapy:
- Distraction: is one of the useful techniques of diverting the patient's attention from what may be perceived as an unpleasant procedure. This enables decreased perception of unpleasantness and averting negative or avoidance behavior. The distraction in this study 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.
- Mindfulness technique:
- Diaphragmatic or relaxation breathing: Diaphragmatic or relaxation breathing in this study 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 relaxation breathing procedure will be repeated twice; at zero time of treatment and after an interval of 16 minutes of dental treatment that extend for a 30-minute duration for each patient. (That mean applied at 0 minute, then at 16 minutes).
- Progressive muscle relaxation: The Progressive muscle relaxation in this study will 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 (which mean after 8 minutes from applying the relaxation breathing technique), and ask the patient to do it twice for about 10 seconds. All these procedures will be repeated twice; at 8 minutes of treatment and at 24 minutes of dental treatment that extend for a duration of 30 minutes for each patient. (That means it is applied at the 8 minute, then at the 24 minute)
The anxiety management intervention and treatment procedure used in this study will be applied for 30 minutes for each dentally anxious patient. This is done for standardization purpose. Follow up dental appointments for these patients will be after three months.
In the control group, Researchers will carry out 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dental anxiety management intervention group | Experimental | Behavioral: Distraction technique by using music therapy., Behavioral: Mindfulness technique by using of relaxation breathing with muscle relaxationin this arm; the patients will under go combination of 2 anxiety management techniques by using of behavioral therapeutic management including; music therapy 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. |
| 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. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Distraction technique by using music therapy.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 | Behavioural | Dental anxiety management intervention group |
| Mindfulness technique by using of relaxation breathing with muscle relaxationThe 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. | Behavioural | Dental anxiety management intervention group |
Primary outcome
The dental anxiety measured by using modified dental anxiety scale MDAS
Time frame: Post intervention measurement of MDAS after 3 months from applying the intervention
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.
1 secondary outcome
Dental anxiety management
Time frame: Post intervention measurement of MDAS after 3 months from applying the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified participant data (demographics, baseline anxiety, outcomes) and statistical code (SPSS syntax) are available from the corresponding author upon reasonable request. Access is limited to academic use under a data-sharing agreement, in line with institutional and ethical guidelines to ensure participant confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer G Doss, Professor study chair
University of Malaya
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distraction technique by using music therapy. and Mindfulness technique by using of relaxation breathing with muscle relaxation in people with Dental Anxiety and Behavioral Management, run by University of Malaya at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iraq, Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The dental anxiety measured by using modified dental anxiety scale MDAS (time frame: Post intervention measurement of MDAS after 3 months from applying the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.