HealhtyNCT07144579
Effect of Music on Pain, Anxiety, and Behavior in Anxious Children During Molar Restorations
A study testing Mozart music group and preferred music group in people with Healhty, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
Managing the child's behavior and anxiety is critical for the treatment in pediatric dentistry to be successful. Behavior management techniques aim to reduce the need for excessive and potentially unsafe medication use. Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Healhty
- What is being tested?
- Mozart music group and preferred music group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to 1 Aug 2025
- 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 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients who applied to the Department of Pediatric Dentistry, Faculty of Dentistry, Mersin University, between 01.08.2024 and 01.08.2025
- Patients with moderate anxiety, scoring 32-38 points on the dental subscale of the Children's Fear Survey Schedule - Dental Subscale (CFSS-DS)
- Voluntary participation of both the child and the parent in the study
- Patients with no previous dental experience
- Absence of any urgent dental condition requiring immediate intervention (e.g., pain, abscess, fistula)
- Systemically healthy patients
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- No previous dental treatment experience
- Signed informed consent form by the parent/guardian
- Children aged between 7 and 10 years
- Patients with dentinal caries in the mandibular permanent first molar
- Patients whose treatment duration is expected to be approximately 30-45 minutes
Who cannot join
- Child and/or parent unwilling to participate in the study
- Failure to sign the informed consent form/written consent form
- Presence of any systemic disease
- Patients with low or high anxiety levels, scoring below 32 or above 38 on the dental subscale of the Children's Fear Survey Schedule - Dental Subscale (CFSS-DS)
- Patients with previous dental experience
- Children younger than 7 years or older than 10 years
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- Caries in the mandibular permanent first molar requiring pulp therapy
- Presence of abscess or inflammation originating from the mandibular permanent first molar
- Absence of caries in the mandibular permanent first molar
- Teeth in which a dental dam cannot be applied
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Music Listening on Pain, Anxiety, and Behavior in Children With Dental Anxiety During the Restoration of Permanent First Molars
Managing the child's behavior and anxiety is critical for the treatment in pediatric dentistry to be successful. Behavior management techniques aim to reduce the need for excessive and potentially unsafe medication use. Audio distraction is a non-intrusive distraction technique in which patients listen to music or a story during a stressful procedure. The success of the vocal distraction technique has been validated in medical settings, but insufficient literature exists to measure the potency of this technique for the pediatric population. The aim of this study is to reveal the effects of listening to music during dental treatment on the anxiety of 45 patients aged 7-10 years with dentist anxiety who applied to Mersin University Faculty of Dentistry Pediatric Dentistry clinic in 2024. The compliance of children who apply for routine examination and treatment by the researcher will be evaluated according to the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS), and if they score between 32-38, they will be invited to the study. Patients who agree to participate in the study will be divided into 3 groups.In the control group consisting of 15 pediatric patients, routine treatment will be performed without any distraction. In the 2nd group (intervention group consisting of 15 people), the patient will receive routine treatment accompanied by music by opening Mozart's Sonata for Two Pianos in D Major, K.448 on the computer in the clinic. In the 3rd group (intervention group consisting of 15 participants), patients will be asked what music they want to listen to and will be played music accordingly. Later, in order to evaluate the effect of the music listened to during dental treatment on anxiety, measurements will be taken at the routine appointment to show the anxiety state before, after and during the treatment. These measurements were determined as a result of literature review as the Children's Fear Research Program Dental Subscale (CFSS-DS), blood pressure, pulse, body temperature, oxygen saturation and salivary cortisol levels. Cortisol levels will be measured using the Cortisol Salivary Enzyme Linked Immunosorbent Assay (ELISA) Test Kit.
- Conditions
- Healhty
- Being tested
- Mozart music group, preferred music group
- Keywords
- cortisol, dental anxiety, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mozart music groupBehavioural
The experimental group was played Mozart - Sonata for Two Pianos in D, K. 448 on the clinic computer.
preferred music groupBehavioural
The experimental group was made to listen to their preferred music in the clinic.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | no audio distraction |
| Mozart Music Group | Active comparator | "Mozart - Sonata for Two Pianos in D, K. 448" music was played Receives: Behavioral: Mozart music group |
| Preferred music group | Active comparator | The patient's requested music was played Receives: Behavioral: preferred music group |
What is being measured
The primary outcome is the main question the study is designed to answer.
pre-treatment and post-treatment cortisol level
The patient's pre-treatment and post-treatment cortisol levels were measured and compared.
Measured: Values were measured on the day of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start1 Aug 2024
- Primary completion1 Jun 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealhtyStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif UĞURBEKLER HÜNDÜ, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144579
- Sponsor's protocol ID
- MersinU-DHF-EUH-01
- Status last verified
- Aug 2025
- First submitted
- 14 Aug 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Music Listening on Pain, Anxiety, and Behavior in Children With Dental Anxiety During the Restoration of Permanent First Molars
- ClinicalTrials.gov ID
- NCT07144579
- Acronym / sponsor ID
- MersinU-DHF-EUH-01
- Conditions
- Healhty
- Keywords
- cortisol, dental anxiety, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 27 Aug 2025 (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.
Managing the child's behavior and anxiety is critical for the treatment in pediatric dentistry to be successful. Behavior management techniques aim to reduce the need for excessive and potentially unsafe medication use. Audio distraction is a non-intrusive distraction technique in which patients listen to music or a story during a stressful procedure. The success of the vocal distraction technique has been validated in medical settings, but insufficient literature exists to measure the potency of this technique for the pediatric population. The aim of this study is to reveal the effects of listening to music during dental treatment on the anxiety of 45 patients aged 7-10 years with dentist anxiety who applied to Mersin University Faculty of Dentistry Pediatric Dentistry clinic in 2024. The compliance of children who apply for routine examination and treatment by the researcher will be evaluated according to the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS), and if they score between 32-38, they will be invited to the study. Patients who agree to participate in the study will be divided into 3 groups.In the control group consisting of 15 pediatric patients, routine treatment will be performed without any distraction. In the 2nd group (intervention group consisting of 15 people), the patient will receive routine treatment accompanied by music by opening Mozart's Sonata for Two Pianos in D Major, K.448 on the computer in the clinic. In the 3rd group (intervention group consisting of 15 participants), patients will be asked what music they want to listen to and will be played music accordingly. Later, in order to evaluate the effect of the music listened to during dental treatment on anxiety, measurements will be taken at the routine appointment to show the anxiety state before, after and during the treatment. These measurements were determined as a result of literature review as the Children's Fear Research Program Dental Subscale (CFSS-DS), blood pressure, pulse, body temperature, oxygen saturation and salivary cortisol levels. Cortisol levels will be measured using the Cortisol Salivary Enzyme Linked Immunosorbent Assay (ELISA) Test Kit.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –no audio distraction |
| Mozart Music Group | Active comparator | Behavioral: Mozart music group"Mozart - Sonata for Two Pianos in D, K. 448" music was played |
| Preferred music group | Active comparator | Behavioral: preferred music groupThe patient's requested music was played |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Patients who applied to the Department of Pediatric Dentistry, Faculty of Dentistry, Mersin University, between 01.08.2024 and 01.08.2025
- Patients with moderate anxiety, scoring 32-38 points on the dental subscale of the Children's Fear Survey Schedule - Dental Subscale (CFSS-DS)
- Voluntary participation of both the child and the parent in the study
- Patients with no previous dental experience
- Absence of any urgent dental condition requiring immediate intervention (e.g., pain, abscess, fistula)
Key exclusion criteria (10 listed)
- Child and/or parent unwilling to participate in the study
- Failure to sign the informed consent form/written consent form
- Presence of any systemic disease
- Patients with low or high anxiety levels, scoring below 32 or above 38 on the dental subscale of the Children's Fear Survey Schedule - Dental Subscale (CFSS-DS)
- Patients with previous dental experience
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 |
|---|---|---|
| Mozart music groupThe experimental group was played Mozart - Sonata for Two Pianos in D, K. 448 on the clinic computer. | Behavioural | Mozart Music Group |
| preferred music groupThe experimental group was made to listen to their preferred music in the clinic. | Behavioural | Preferred music group |
Primary outcome
pre-treatment and post-treatment cortisol level
Time frame: Values were measured on the day of treatment.
The patient's pre-treatment and post-treatment cortisol levels were measured and compared.
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 27 Aug 2025.
- Individual participant dataSharing planned: No
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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 Mozart music group and preferred music group in people with Healhty, run by Mersin University 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 11 inclusion and 10 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 27 Aug 2025. 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?
pre-treatment and post-treatment cortisol level (time frame: Values were measured on the day of treatment.). 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 27 Aug 2025.