FrenectomyNCT07687953
Effect of Music Listening on Anxiety During Diode Laser Frenectomy
A study testing Music Listening in people with Frenectomy and Dental Anxiety, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial evaluated the effect of music listening on anxiety, stress, and pain in patients undergoing diode laser frenectomy. Participants were adults aged 18 to 65 years who were scheduled to receive frenectomy as part of their routine periodontal treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Frenectomy, Dental Anxiety, Perceived Stress
- What is being tested?
- Music Listening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Apr 2025to 31 Oct 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 65 years Patients scheduled for diode laser frenectomy as part of routine periodontal treatment Patients who completed phase 1 periodontal treatment before frenectomy Patients who agreed to participate in the study and signed the informed consent form Patients who smoked fewer than 10 cigarettes per day, if applicable
Who cannot join
- Patients with any uncontrolled systemic disease Pregnant or breastfeeding patients Patients younger than 18 years or older than 65 years Patients who smoked 10 or more cigarettes per day Patients who did not agree to participate or did not provide informed consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University Faculty of Dentistry, Department of Periodontology
Konya, Meram, 42090
About this study
Official title: Effect of Music Listening on Anxiety, Stress, and Pain During Frenectomy: A Randomized Controlled Trial
This randomized controlled trial evaluated the effect of music listening on anxiety, stress, and pain in patients undergoing diode laser frenectomy. Participants were adults aged 18 to 65 years who were scheduled to receive frenectomy as part of their routine periodontal treatment. Participants were allocated into two groups: a music group, in which patients listened to a pre-recorded music performance during the procedure, and a control group, in which patients received the routine procedure without music.
Anxiety and stress levels were assessed using validated questionnaires before and after the procedure. Postoperative pain was evaluated using a visual analogue scale. In the music group, patients also completed an additional questionnaire about their experience with music during the procedure. The study aimed to determine whether listening to music during frenectomy could improve patient comfort by reducing anxiety, perceived stress, and pain.
Read the detailed description
Dental anxiety, perceived stress, and postoperative pain can negatively affect patient comfort and cooperation during minor oral surgical procedures. Music listening is a simple, low-cost, and non-pharmacological approach that may help reduce anxiety and improve the perioperative experience.
This randomized controlled trial was conducted in adult patients scheduled for diode laser frenectomy as part of routine periodontal care. Participants were allocated to either a music listening group or a control group. In the music group, patients listened to a pre-recorded instrumental music performance during the procedure. The music recording was performed by academic staff from the Department of Instrument Education, Turkish Music State Conservatory, Necmettin Erbakan University. Patients in the control group underwent the same routine diode laser frenectomy procedure without music listening.
The study evaluated patient-centered outcomes related to anxiety, perceived stress, and pain. Dental anxiety was assessed before and after the procedure using validated dental anxiety scales. Perceived stress was assessed before and after the procedure using the Perceived Stress Scale. Postoperative pain intensity was evaluated using a visual analogue scale. In addition, participants in the music group completed a questionnaire about their experience with music listening during the procedure, including their comfort, satisfaction, and willingness to receive music during a similar treatment in the future.
The purpose of the study was to determine whether music listening during diode laser frenectomy could reduce anxiety, stress, and pain and improve patient comfort during routine periodontal surgical care.
- Conditions
- Frenectomy, Dental Anxiety, Perceived Stress
- Being tested
- Music Listening
- Keywords
- Music Listening, Frenectomy, Perceived Stress Scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music ListeningBehavioural
Also called Music Intervention, Music Listening During Frenectomy, Intraoperative Music Listening
Participants assigned to the music listening group listened to a pre-recorded instrumental Turkish music performance during diode laser frenectomy. The music was played as an adjunct to routine clinical care and was intended to improve patient comfort during the procedure. Participants in the control group received the same routine diode laser frenectomy procedure without music listening.
| Study group | Role | What they receive |
|---|---|---|
| Music Listening Group | Experimental | Participants in this group listened to pre-recorded instrumental music during diode laser frenectomy in addition to routine clinical care. Receives: Behavioral: Music Listening |
| Control Group | No intervention | Participants in this group underwent routine diode laser frenectomy without music listening. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Modified Dental Anxiety Scale Score
Dental anxiety was assessed using the Modified Dental Anxiety Scale before and after diode laser frenectomy. Higher scores indicate greater dental anxiety. The change in score from preoperative to postoperative assessment was compared between the music listening group and the control group.
Measured: Preoperative and immediately postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start28 Apr 2025
- Primary completion1 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrenectomyStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Özkan Şen, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687953
- Sponsor's protocol ID
- NEU-DHF-PERIO-FM
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- 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 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Music Listening on Anxiety, Stress, and Pain During Frenectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07687953
- Acronym / sponsor ID
- NEU-DHF-PERIO-FM
- Conditions
- Frenectomy, Dental Anxiety, Perceived Stress
- Keywords
- Music Listening, Frenectomy, Perceived Stress Scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 7 Jul 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 randomized controlled trial evaluated the effect of music listening on anxiety, stress, and pain in patients undergoing diode laser frenectomy. Participants were adults aged 18 to 65 years who were scheduled to receive frenectomy as part of their routine periodontal treatment. Participants were allocated into two groups: a music group, in which patients listened to a pre-recorded music performance during the procedure, and a control group, in which patients received the routine procedure without music.
Anxiety and stress levels were assessed using validated questionnaires before and after the procedure. Postoperative pain was evaluated using a visual analogue scale. In the music group, patients also completed an additional questionnaire about their experience with music during the procedure. The study aimed to determine whether listening to music during frenectomy could improve patient comfort by reducing anxiety, perceived stress, and pain.
Detailed description
Dental anxiety, perceived stress, and postoperative pain can negatively affect patient comfort and cooperation during minor oral surgical procedures. Music listening is a simple, low-cost, and non-pharmacological approach that may help reduce anxiety and improve the perioperative experience.
This randomized controlled trial was conducted in adult patients scheduled for diode laser frenectomy as part of routine periodontal care. Participants were allocated to either a music listening group or a control group. In the music group, patients listened to a pre-recorded instrumental music performance during the procedure. The music recording was performed by academic staff from the Department of Instrument Education, Turkish Music State Conservatory, Necmettin Erbakan University. Patients in the control group underwent the same routine diode laser frenectomy procedure without music listening.
The study evaluated patient-centered outcomes related to anxiety, perceived stress, and pain. Dental anxiety was assessed before and after the procedure using validated dental anxiety scales. Perceived stress was assessed before and after the procedure using the Perceived Stress Scale. Postoperative pain intensity was evaluated using a visual analogue scale. In addition, participants in the music group completed a questionnaire about their experience with music listening during the procedure, including their comfort, satisfaction, and willingness to receive music during a similar treatment in the future.
The purpose of the study was to determine whether music listening during diode laser frenectomy could reduce anxiety, stress, and pain and improve patient comfort during routine periodontal surgical care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Listening Group | Experimental | Behavioral: Music ListeningParticipants in this group listened to pre-recorded instrumental music during diode laser frenectomy in addition to routine clinical care. |
| Control Group | No intervention | –Participants in this group underwent routine diode laser frenectomy without music listening. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 18 to 65 years Patients scheduled for diode laser frenectomy as part of routine periodontal treatment Patients who completed phase 1 periodontal treatment before frenectomy Patients who agreed to participate in the study and signed the informed consent form Patients who smoked fewer than 10 cigarettes per day, if applicable
Key exclusion criteria (1 listed)
- Patients with any uncontrolled systemic disease Pregnant or breastfeeding patients Patients younger than 18 years or older than 65 years Patients who smoked 10 or more cigarettes per day Patients who did not agree to participate or did not provide informed consent
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 ListeningAlso: Music Intervention, Music Listening During Frenectomy, Intraoperative Music ListeningParticipants assigned to the music listening group listened to a pre-recorded instrumental Turkish music performance during diode laser frenectomy. The music was played as an adjunct to routine clinical care and was intended to improve patient comfort during the procedure. Participants in the control group received the same routine diode laser frenectomy procedure without music listening. | Behavioural | Music Listening Group |
Primary outcome
Change in Modified Dental Anxiety Scale Score
Time frame: Preoperative and immediately postoperative
Dental anxiety was assessed using the Modified Dental Anxiety Scale before and after diode laser frenectomy. Higher scores indicate greater dental anxiety. The change in score from preoperative to postoperative assessment was compared between the music listening group and the control group.
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 7 Jul 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 Listening in people with Frenectomy and Dental Anxiety, run by Necmettin Erbakan 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 1 inclusion and 1 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 7 Jul 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?
Change in Modified Dental Anxiety Scale Score (time frame: Preoperative and immediately postoperative). 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 7 Jul 2026.