Effects of Music Therapy on Stress During Orthodontic Mini-screw Placement

NCT07793669 | Completed

• 1 other identifier: OMT-MS-2025-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Acute Stress Response During Orthodontic Mini-screw Placement

Keywords

Music Therapy; Salivary Cortisol; Salivary Alpha-amylase; Physiological Stress Response

Outcome Measures

Primary Outcomes (1)

• Change in Salivary Cortisol Level

  Immediately before and immediately after orthodontic mini-screw placement

Secondary Outcomes (6)

• Change in Salivary Alpha-amylase Level

  Immediately before and immediately after orthodontic mini-screw placement

• Change in Pulse rate

  Immediately before and immediately after orthodontic mini-screw placement

• Change in Systolic blood pressure

  Immediately before and immediately after orthodontic mini-screw placement

• Change in Diastolic Blood Pressure

  Immediately before and immediately after orthodontic mini-screw placement

• Change in Body temparature

  Immediately before and immediately after orthodontic mini-screw placement

Study Arms (2)

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.

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.

Interventions

Music Listening Intervention BEHAVIORAL

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.

Also known as: Music Therapy

Music Intervention Group

Eligibility Criteria

• Age: 14 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Aged 14 to 20 years Scheduled to undergo orthodontic mini-screw placement for the first time Healthy, with no systemic disease

You may not qualify if:

• 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

Sponsors & Collaborators

• Himmet YILDIRIM: lead
• Kırıkkale University Medical Faculty Hospital: collaborator

Study Sites (1)

Kırıkkale University Faculty of Dentistry, Department of Orthodontics

Yahşihan, Kırıkkale, 71450, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and the clinician performing the procedure were not masked because of the nature of the music intervention. Laboratory personnel analyzing the saliva samples and the statistician were masked to group allocation. Samples and study data were identified using coded labels.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 28, 2026
• Study Start: February 5, 2025
• Primary Completion: May 27, 2025
• Study Completion: May 27, 2025
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: De-identified individual participant data and supporting information will be available beginning three months after publication of the study results and will remain available for five years.
• Access Criteria: Data will be made available to researchers who submit a methodologically sound proposal to the corresponding author. Requests will be evaluated for compatibility with the approved purpose, ethics requirements, and institutional data-sharing policies. Access will be subject to ethics approval, where required, and completion of an appropriate data-use agreement. Data may be used only for the purposes specified in the approved proposal.

Locations

TU (1)