Dental AnxietyNCT07536828
Effect of Music on Anxiety, Pulse Rate, and Pain During Fissure Sealant Application in Children
A study testing Music intervention 1 and Music intervention 2 in people with Dental Anxiety and Pediatric Dental Patients, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the effects of music on anxiety, heart rate, and pain perception in children during fissure sealant application, and to compare the effectiveness of clinician-selected and patient-selected music. A total of 90 children aged 6-9 years were included in this split-mouth study. Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Dental Anxiety, Pediatric Dental Patients, Dental Procedures
- What is being tested?
- Music intervention 1 and Music intervention 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 May 2025to 27 Feb 2026
- 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 6 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6-9 years
- Children with at least 3 fully erupted permanent first molars
- Children requiring pit and fissure sealant application
- Children with no previous dental treatment experience
- Children without learning disabilities
- Children without any systemic diseases
Who cannot join
- Children with any physical or mental disability
- Children who have previously experienced any psychological disorder that could affect anxiety measurement
- Children who have previously received fissure sealant or any other dental treatment
- Children whose permanent first molars have not fully erupted, are carious, or have previously undergone other procedures
- Children who were unable to cooperate during the procedure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Niğde Ömer Halisdemir University Faculty of Dentistry
Niğde, 51100
About this study
Official title: ''I Chose This Music!" Effect: Comparison of Anxiety, Pulse Rate and Pain During Fissure Sealant Application in Children Between Favorite Songs, Classical Music and Silence
This study aimed to evaluate the effects of music on anxiety, heart rate, and pain perception in children during fissure sealant application, and to compare the effectiveness of clinician-selected and patient-selected music. A total of 90 children aged 6-9 years were included in this split-mouth study. Each child received fissure sealant treatment on three permanent first molars under three different conditions: no music, clinician-selected music, and patient-selected music. Anxiety levels were assessed using the Facial Image Scale (FIS), heart rate was measured with a pulse oximeter, and pain perception was evaluated using the Wong-Baker Pain Scale. Measurements were recorded before and after each procedure. Data were analyzed using paired t-tests and repeated measures ANOVA with Bonferroni correction.
- Conditions
- Dental Anxiety, Pediatric Dental Patients, Dental Procedures, Pain Perception, Fissure Sealant
- Being tested
- Music intervention 1, Music intervention 2
- Keywords
- Pediatric Dentistry, Auditory Distraction, Pain Measurement, Dental Anxiety, Music Therapy, Pit and Fissure Sealants
- Medical subject headings
- Van der Woude syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music intervention 1Other
Participants listened to a standardized classical music piece (Pachelbel's Canon in D Major) played through a speaker for approximately 5 minutes during the procedure. The volume was kept constant.
Music intervention 2Other
Participants listened to their preferred music played through a speaker for approximately 5 minutes during the procedure. If the selected music was shorter than 5 minutes, it was replayed to standardize the duration. The volume was kept constant.
| Study group | Role | What they receive |
|---|---|---|
| Control Condition | No intervention | Fissure sealant application performed without music. |
| Researcher-Selected Music | Experimental | Fissure sealant application performed while listening to researcher-selected classical music. Receives: Other: Music intervention 1 |
| Patient-Selected Music | Experimental | Fissure sealant application performed while listening to music chosen by the patient. Receives: Other: Music intervention 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Level
Anxiety levels of children were assessed using the Facial Image Scale before and after each intervention.The scale was scored by ranging from 1 (most positive emotion) to 5 (most negative emotion).
Measured: Immediately before and after the procedure
Pulse Rate
The children's pulses were assessed before and after each intervention using a finger pulse oximeter.
Measured: Immediately before and after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start24 May 2025
- Primary completion20 Jan 2026
- Study completion27 Feb 2026
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
- Crossover
- Model description
- This study was designed as a split-mouth randomized crossover trial in which each participant received all three interventions (control, researcher-selected music, and patient-selected music) in different sequences.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07536828
- Sponsor's protocol ID
- NigdeOHU-FissureMusic
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 22 Apr 2026
- 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 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ''I Chose This Music!" Effect: Comparison of Anxiety, Pulse Rate and Pain During Fissure Sealant Application in Children Between Favorite Songs, Classical Music and Silence
- ClinicalTrials.gov ID
- NCT07536828
- Acronym / sponsor ID
- NigdeOHU-FissureMusic
- Conditions
- Dental Anxiety, Pediatric Dental Patients, Dental Procedures, Pain Perception, Fissure Sealant
- Keywords
- Pediatric Dentistry, Auditory Distraction, Pain Measurement, Dental Anxiety, Music Therapy, Pit and Fissure Sealants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Study start
- 24 May 2025 (actual)
- Primary completion
- 20 Jan 2026 (actual)
- Study completion
- 27 Feb 2026 (actual)
- First posted
- 17 Apr 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.
This study aimed to evaluate the effects of music on anxiety, heart rate, and pain perception in children during fissure sealant application, and to compare the effectiveness of clinician-selected and patient-selected music. A total of 90 children aged 6-9 years were included in this split-mouth study. Each child received fissure sealant treatment on three permanent first molars under three different conditions: no music, clinician-selected music, and patient-selected music. Anxiety levels were assessed using the Facial Image Scale (FIS), heart rate was measured with a pulse oximeter, and pain perception was evaluated using the Wong-Baker Pain Scale. Measurements were recorded before and after each procedure. Data were analyzed using paired t-tests and repeated measures ANOVA with Bonferroni correction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study was designed as a split-mouth randomized crossover trial in which each participant received all three interventions (control, researcher-selected music, and patient-selected music) in different sequences.
| Arm | Type | Receives |
|---|---|---|
| Control Condition | No intervention | –Fissure sealant application performed without music. |
| Researcher-Selected Music | Experimental | Other: Music intervention 1Fissure sealant application performed while listening to researcher-selected classical music. |
| Patient-Selected Music | Experimental | Other: Music intervention 2Fissure sealant application performed while listening to music chosen by the patient. |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children aged 6-9 years
- Children with at least 3 fully erupted permanent first molars
- Children requiring pit and fissure sealant application
- Children with no previous dental treatment experience
- Children without learning disabilities
Key exclusion criteria (5 listed)
- Children with any physical or mental disability
- Children who have previously experienced any psychological disorder that could affect anxiety measurement
- Children who have previously received fissure sealant or any other dental treatment
- Children whose permanent first molars have not fully erupted, are carious, or have previously undergone other procedures
- Children who were unable to cooperate during the procedure
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 intervention 1Participants listened to a standardized classical music piece (Pachelbel's Canon in D Major) played through a speaker for approximately 5 minutes during the procedure. The volume was kept constant. | Other | Researcher-Selected Music |
| Music intervention 2Participants listened to their preferred music played through a speaker for approximately 5 minutes during the procedure. If the selected music was shorter than 5 minutes, it was replayed to standardize the duration. The volume was kept constant. | Other | Patient-Selected Music |
Primary outcome
Anxiety Level
Time frame: Immediately before and after the procedure
Anxiety levels of children were assessed using the Facial Image Scale before and after each intervention.The scale was scored by ranging from 1 (most positive emotion) to 5 (most negative emotion).
Pulse Rate
Time frame: Immediately before and after the procedure
The children's pulses were assessed before and after each intervention using a finger pulse oximeter.
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 Apr 2026.
- 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 Music intervention 1 and Music intervention 2 in people with Dental Anxiety and Pediatric Dental Patients, run by Nigde Omer Halisdemir 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 6 inclusion and 5 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 Apr 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?
Anxiety Level (time frame: Immediately before and after the procedure). The study lists 2 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 Apr 2026.