Dental AnxietyMUSIC-CEDAMNCT07350993
Effect of Music on Dental Anxiety in Children: Turkish Validation of the CEDAM
A study testing Music Listening Intervention in people with Dental Anxiety, run by Şevval Çakıcı at 1 site in Turkey (Türkiye).
Trial summary
The study will consist of two phases. In the first phase, the validity and reliability of the children's experiences of dental anxiety measure (CEDAM) scales will be assessed in children aged 9-16 years using item analysis, content and construct validity, internal consistency, and test-retest reliability. Read more about this study
- Who is it for?
- Ages 9 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Music Listening Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Apr 2024to 31 Oct 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 9 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 9-16 years
- Systemically healthy children
- Native Turkish speakers
- Written informed consent obtained from both the child and a parent or legal guardian
Who cannot join
- Presence of any mental or physical disability
- History of psychiatric or developmental disorders
- Known allergies
- Use of medications
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kütahya Health Sciences University Faculty of Dentistry
Kütahya, Kütahya, 43100
About this study
Official title: Evaluation of the Effect of Music on the Management of Dental Anxiety in Children: Turkish Validity and Reliability Study of the CEDAM-A Randomized Controlled Clinical Trial
The study will consist of two phases. In the first phase, the validity and reliability of the children's experiences of dental anxiety measure (CEDAM) scales will be assessed in children aged 9-16 years using item analysis, content and construct validity, internal consistency, and test-retest reliability.
In the second phase, the effect of music will be evaluated in a randomized controlled trial involving children aged 9-12 years. The study will employ a three-session design with progressively increasing procedural invasiveness. In the final session, the control group will receive basic behavior guidance, while the intervention group will additionally listen to music during the dental procedure.
Perioperative anxiety will be assessed using the Children's Anxiety Meter-State (CAM-S), Children's Emotional Manifestation Scale (CEMS), and short version of the CEDAM (CEDAM-8). A conceptual model will be used to examine the relationships between music intervention, preoperative anxiety, intraoperative anxiety, and postoperative anxiety.
Read the detailed description
The study will be conducted in two sequential phases. In the first phase, the cross-cultural validity and reliability of the children's experiences of dental anxiety measure (CEDAM) will be assessed in children aged 9-16 years. In the second phase, a subgroup of children aged 9-12 years will be selected from the Phase 1 sample to participate in a randomized controlled trial evaluating the effect of a music intervention on perioperative dental anxiety. Only children requiring at least a second and third dental appointment will be eligible for Phase 2.
- Conditions
- Dental Anxiety
- Being tested
- Music Listening Intervention
- Keywords
- Behavior guidance, Dental anxiety, Validity, Reliability, Music
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music Listening InterventionBehavioural
Also called Classical Music Listening
Children will listen to classical instrumental music through headphones during the dental procedure to reduce anxiety levels.
| Study group | Role | What they receive |
|---|---|---|
| Music Intervention Group | Experimental | Children will listen to classical music during dental treatment to assess the effect on dental anxiety. Receives: Behavioral: Music Listening Intervention |
| Control Group | No intervention | Children will receive dental treatment without any music intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Anxiety Meter-State (CAM-S) Score
Description: A projective measurement tool consisting of a thermometer-like scale with 10 horizontal lines. The scale evaluates state anxiety levels. Scores range from 1 to 10, where higher scores indicate higher levels of anxiety.
Unit of Measure: CAM-S score
Measured: Baseline (5 minutes before start of the dental procedure), intra-procedural (immediately after administration of local anesthesia), and post-procedural (5 minutes after completion of the dental procedure)
Children's Emotional Manifestation Scale (CEMS) Score
Description: An observational behavioral assessment tool that evaluates five main categories: facial expression, vocalization, activity, interaction, and cooperation. Each category is rated on a 5-point scale. Total scores range from 5 to 25, where higher scores indicate higher levels of behavioral anxiety.
Unit of Measure: CEMS score
Measured: Periprocedural (from seating in the dental chair to completion of the dental procedure)
Children's Experiences of Dental Anxiety Measure (CEDAM-8) Score
Description: A psychometric tool based on cognitive-behavioral therapy. It consists of 8 questions assessing thoughts, behaviors, physical symptoms, and feelings related to dental anxiety. Responses are recorded on a 3-point Likert scale. Total scores range from 8 to 24, where higher scores indicate greater dental anxiety.
Unit of Measure: CEDAM-8 score
Measured: Baseline (5 minutes before start of the dental procedure) and post-procedural (5 minutes after completion of the dental procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start22 Apr 2024
- Primary completion31 Oct 2024
- Study completion31 Oct 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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study used a parallel-group design with two groups: a music intervention group and a control group. Participants in the intervention group listened to classical instrumental music during dental treatment, while the control group received treatment without music.
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Şevval Çakıcı
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Şevval Çakıcı, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350993
- Sponsor's protocol ID
- CAKICIAKKOC-DENTALANXIETY
- Other IDs
- 2024/05-32
- Acronym
- MUSIC-CEDAM
- Status last verified
- Oct 2026
- First submitted
- 17 Dec 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Music on the Management of Dental Anxiety in Children: Turkish Validity and Reliability Study of the CEDAM-A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07350993
- Acronym / sponsor ID
- MUSIC-CEDAM / CAKICIAKKOC-DENTALANXIETY
- Conditions
- Dental Anxiety
- Keywords
- Behavior guidance, Dental anxiety, Validity, Reliability, Music
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Şevval ÇakıcıUniversity, hospital or other
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 20 Jan 2026 (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.
The study will consist of two phases. In the first phase, the validity and reliability of the children's experiences of dental anxiety measure (CEDAM) scales will be assessed in children aged 9-16 years using item analysis, content and construct validity, internal consistency, and test-retest reliability.
In the second phase, the effect of music will be evaluated in a randomized controlled trial involving children aged 9-12 years. The study will employ a three-session design with progressively increasing procedural invasiveness. In the final session, the control group will receive basic behavior guidance, while the intervention group will additionally listen to music during the dental procedure.
Perioperative anxiety will be assessed using the Children's Anxiety Meter-State (CAM-S), Children's Emotional Manifestation Scale (CEMS), and short version of the CEDAM (CEDAM-8). A conceptual model will be used to examine the relationships between music intervention, preoperative anxiety, intraoperative anxiety, and postoperative anxiety.
Detailed description
The study will be conducted in two sequential phases. In the first phase, the cross-cultural validity and reliability of the children's experiences of dental anxiety measure (CEDAM) will be assessed in children aged 9-16 years. In the second phase, a subgroup of children aged 9-12 years will be selected from the Phase 1 sample to participate in a randomized controlled trial evaluating the effect of a music intervention on perioperative dental anxiety. Only children requiring at least a second and third dental appointment will be eligible for Phase 2.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study used a parallel-group design with two groups: a music intervention group and a control group. Participants in the intervention group listened to classical instrumental music during dental treatment, while the control group received treatment without music.
| Arm | Type | Receives |
|---|---|---|
| Music Intervention Group | Experimental | Behavioral: Music Listening InterventionChildren will listen to classical music during dental treatment to assess the effect on dental anxiety. |
| Control Group | No intervention | –Children will receive dental treatment without any music intervention. |
Who may qualify
- Ages
- 9 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 9-16 years
- Systemically healthy children
- Native Turkish speakers
- Written informed consent obtained from both the child and a parent or legal guardian
Key exclusion criteria (4 listed)
- Presence of any mental or physical disability
- History of psychiatric or developmental disorders
- Known allergies
- Use of medications
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 |
|---|---|---|
| Music Listening InterventionAlso: Classical Music ListeningChildren will listen to classical instrumental music through headphones during the dental procedure to reduce anxiety levels. | Behavioural | Music Intervention Group |
Primary outcome
Children's Anxiety Meter-State (CAM-S) Score
Time frame: Baseline (5 minutes before start of the dental procedure), intra-procedural (immediately after administration of local anesthesia), and post-procedural (5 minutes after completion of the dental procedure)
Description: A projective measurement tool consisting of a thermometer-like scale with 10 horizontal lines. The scale evaluates state anxiety levels. Scores range from 1 to 10, where higher scores indicate higher levels of anxiety. Unit of Measure: CAM-S score
Children's Emotional Manifestation Scale (CEMS) Score
Time frame: Periprocedural (from seating in the dental chair to completion of the dental procedure)
Description: An observational behavioral assessment tool that evaluates five main categories: facial expression, vocalization, activity, interaction, and cooperation. Each category is rated on a 5-point scale. Total scores range from 5 to 25, where higher scores indicate higher levels of behavioral anxiety. Unit of Measure: CEMS score
Children's Experiences of Dental Anxiety Measure (CEDAM-8) Score
Time frame: Baseline (5 minutes before start of the dental procedure) and post-procedural (5 minutes after completion of the dental procedure)
Description: A psychometric tool based on cognitive-behavioral therapy. It consists of 8 questions assessing thoughts, behaviors, physical symptoms, and feelings related to dental anxiety. Responses are recorded on a 3-point Likert scale. Total scores range from 8 to 24, where higher scores indicate greater dental anxiety. Unit of Measure: CEDAM-8 score
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 22 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Listening Intervention in people with Dental Anxiety, run by Şevval Çakıcı at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. 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 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Children's Anxiety Meter-State (CAM-S) Score (time frame: Baseline (5 minutes before start of the dental procedure), intra-procedural (immediately after administration of local anesthesia), and post-procedural (5 minutes after completion of the dental procedure)). The study lists 3 primary outcomes in all. 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 22 Oct 2026.