Acute Stress Response During Orthodontic Mini-screw PlacementNCT07793669
Effects of Music Therapy on Stress During Orthodontic Mini-screw Placement
A study testing Music Listening Intervention in people with Acute Stress Response During Orthodontic Mini-screw Placement, run by Himmet YILDIRIM at 1 site in Turkey (Türkiye).
Trial summary
This randomized clinical trial evaluated acute stress responses during orthodontic mini-screw placement and whether listening to music during the procedure influenced these responses. Read more about this study
- Who is it for?
- Ages 14 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Stress Response During Orthodontic Mini-screw Placement
- 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
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Feb 2025to 27 May 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 14 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Aged 14 to 20 years Scheduled to undergo orthodontic mini-screw placement for the first time Healthy, with no systemic disease
Who cannot join
- Regular alcohol use Pregnancy, oral contraceptive use, or being in the menstrual period at the study visit Psychiatric or psychological disorders Use of antihistamine, antipsychotic, antidepressant, or anticholinergic medications Hearing impairment Oral lesions History of salivary gland disease or surgery involving the salivary glands
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırıkkale University Faculty of Dentistry, Department of Orthodontics
Yahşihan, Kırıkkale, 71450
About this study
Official title: Effects of Music Therapy on Physiological Stress Responses During Orthodontic Mini-screw Placement: A Randomized Clinical Trial
This randomized clinical trial evaluated acute stress responses during orthodontic mini-screw placement and whether listening to music during the procedure influenced these responses. Thirty-two participants aged 14 to 20 years who were undergoing mini-screw placement for the first time were randomly assigned in equal numbers to a music intervention group or a control group receiving the same orthodontic procedure without music. Saliva samples were collected immediately before and after the procedure to measure salivary cortisol and alpha-amylase. Pulse rate, systolic and diastolic blood pressure, body temperature, and oxygen saturation were also measured at the same time points. The study was designed to determine whether mini-screw placement produced a measurable acute stress response and whether music influenced biochemical and physiological changes associated with the procedure.
- Being tested
- Music Listening Intervention
- Keywords
- Music Therapy, Salivary Cortisol, Salivary Alpha-amylase, Physiological Stress Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music Listening InterventionBehavioural
Also called Music Therapy
Participants assigned to the experimental arm listened to the same prespecified music throughout the standardized orthodontic mini-screw placement procedure. The music intervention was initiated after completion of the baseline saliva collection and physiological measurements and continued until the clinical procedure was completed. Post-procedure saliva collection and physiological measurements were then performed. Participants in the control arm underwent the same clinical procedure and measurement protocol without music.
| Study group | Role | What they receive |
|---|---|---|
| Music Intervention Group | Experimental | Participants underwent standardized orthodontic mini-screw placement while listening to the study music during the procedure. Saliva samples and physiological measurements were obtained immediately before and after mini-screw placement. Receives: Behavioral: Music Listening Intervention |
| Control Group | No intervention | Participants underwent the same standardized orthodontic mini-screw placement procedure without music. Saliva samples and physiological measurements were obtained immediately before and after mini-screw placement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Salivary Cortisol Level
Measured: Immediately before and immediately after orthodontic mini-screw placement
Secondary outcomes (6)
Change in Salivary Alpha-amylase Level
Measured: Immediately before and immediately after orthodontic mini-screw placement
Change in Pulse rate
Measured: Immediately before and immediately after orthodontic mini-screw placement
Change in Systolic blood pressure
Measured: Immediately before and immediately after orthodontic mini-screw placement
Change in Diastolic Blood Pressure
Measured: Immediately before and immediately after orthodontic mini-screw placement
Change in Body temparature
Measured: Immediately before and immediately after orthodontic mini-screw placement
Change in Oxygen Saturation
Measured: Immediately before and immediately after orthodontic mini-screw placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start5 Feb 2025
- Primary completion27 May 2025
- Study completion27 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Stress Response During Orthodontic Mini-screw PlacementStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Himmet YILDIRIM
- Sponsor type
- University, hospital or other
- Collaborators
- Kırıkkale University Medical Faculty Hospital
- Responsible party
- Sponsor-investigator, Himmet YILDIRIM, Aksaray University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793669
- Sponsor's protocol ID
- OMT-MS-2025-01
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Music Therapy on Physiological Stress Responses During Orthodontic Mini-screw Placement: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07793669
- Acronym / sponsor ID
- OMT-MS-2025-01
- Keywords
- Music Therapy, Salivary Cortisol, Salivary Alpha-amylase, Physiological Stress Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Himmet YILDIRIMUniversity, hospital or other
- Collaborators
- Kırıkkale University Medical Faculty Hospital
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- 27 May 2025 (actual)
- Study completion
- 27 May 2025 (actual)
- First posted
- 28 Aug 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 clinical trial evaluated acute stress responses during orthodontic mini-screw placement and whether listening to music during the procedure influenced these responses. Thirty-two participants aged 14 to 20 years who were undergoing mini-screw placement for the first time were randomly assigned in equal numbers to a music intervention group or a control group receiving the same orthodontic procedure without music. Saliva samples were collected immediately before and after the procedure to measure salivary cortisol and alpha-amylase. Pulse rate, systolic and diastolic blood pressure, body temperature, and oxygen saturation were also measured at the same time points. The study was designed to determine whether mini-screw placement produced a measurable acute stress response and whether music influenced biochemical and physiological changes associated with the procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Intervention Group | Experimental | Behavioral: Music Listening InterventionParticipants underwent standardized orthodontic mini-screw placement while listening to the study music during the procedure. Saliva samples and physiological measurements were obtained immediately before and after mini-screw placement. |
| Control Group | No intervention | –Participants underwent the same standardized orthodontic mini-screw placement procedure without music. Saliva samples and physiological measurements were obtained immediately before and after mini-screw placement. |
Who may qualify
- Ages
- 14 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Aged 14 to 20 years Scheduled to undergo orthodontic mini-screw placement for the first time Healthy, with no systemic disease
Key exclusion criteria (1 listed)
- Regular alcohol use Pregnancy, oral contraceptive use, or being in the menstrual period at the study visit Psychiatric or psychological disorders Use of antihistamine, antipsychotic, antidepressant, or anticholinergic medications Hearing impairment Oral lesions History of salivary gland disease or surgery involving the salivary glands
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: Music TherapyParticipants assigned to the experimental arm listened to the same prespecified music throughout the standardized orthodontic mini-screw placement procedure. The music intervention was initiated after completion of the baseline saliva collection and physiological measurements and continued until the clinical procedure was completed. Post-procedure saliva collection and physiological measurements were then performed. Participants in the control arm underwent the same clinical procedure and measurement protocol without music. | Behavioural | Music Intervention Group |
Primary outcome
Change in Salivary Cortisol Level
Time frame: Immediately before and immediately after orthodontic mini-screw placement
6 secondary outcomes
Change in Salivary Alpha-amylase Level
Time frame: Immediately before and immediately after orthodontic mini-screw placement
Change in Pulse rate
Time frame: Immediately before and immediately after orthodontic mini-screw placement
Change in Systolic blood pressure
Time frame: Immediately before and immediately after orthodontic mini-screw placement
Change in Diastolic Blood Pressure
Time frame: Immediately before and immediately after orthodontic mini-screw placement
Change in Body temparature
Time frame: Immediately before and immediately after orthodontic mini-screw placement
Change in Oxygen Saturation
Time frame: Immediately before and immediately after orthodontic mini-screw placement
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 28 Aug 2026.
- Individual participant dataSharing planned: Yes
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 Acute Stress Response During Orthodontic Mini-screw Placement, run by Himmet YILDIRIM 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 28 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 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 Salivary Cortisol Level (time frame: Immediately before and immediately after orthodontic mini-screw placement). 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 28 Aug 2026.