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Clinical Trials/NCT07274501
NCT07274501Active, not recruitingNot Applicable

The Evaluation of the Effect of Music That the Individuals With Moderate Dental Anxiety Have Started Listening to on Their Anxiety Levels While Waiting for Restorative Dental Treatments in the Patient Waiting Room

Karadeniz Technical University2 sites in 1 country90 target enrollmentStarted: April 17, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
90
Locations
2
Primary Endpoint
Salivary cortisol level and oxytocin levels

Study Overview

Brief Summary

It is aimed to evaluate the effect of music listened to in the waiting room on patients with moderate dental anxiety during the restoration of posterior occlusal dental caries on vital signs, cortisol and oxytocin levels of the participants.

Detailed Description

The study will be conducted on 90 patients.

30 patients will be in the control group (the group that listens to no music at all), 30 patients will be in the first experimental group (the group that begins listening to music before treatment and will not listen to music during dental treatment), and 30 patients will be in the second experimental group (the group that begins listening to music in the waiting room and continues listening to music during dental treatment).

The study groups will consist of individuals with moderate anxiety who are systemically healthy and free of any disease. Class I occlusal restorations will be placed on permanent posterior teeth. The study groups will consist of individuals over the age of 18, with no systemic disease, and who are not taking any medication. The groups will be arranged so that there is no significant difference between the number of men and women. The individuals will have occlusal caries to be restored. There will be no condition that would prevent the placement of a rubber dam on the teeth. Pregnant women will not be included in the study. Patients who wish to participate will be included in the study on a voluntary basis after being informed about the study. The Modified Dental Anxiety Scale (MDAS) will be used to determine our patients' dental anxiety levels. Each question in the five-question test will be scored from 1 to 5, and the scores will be added together to create a dental anxiety score. The moderate dental anxiety range is between 10 and 18 and is the level generally included in dental anxiety studies. Patients with an appropriate score will be given an appointment for treatment. Before coming in for treatment, individuals will be asked not to have engaged in intense physical exercise and not to have consumed alcohol, smoked, or consumed caffeinated beverages such as coffee. Patients who accept these conditions will sign an informed consent form and provide a medical history (anamnesis) before starting treatment. During treatment, after the application of a local anesthetic without a vasoconstrictor, a rubber dam isolation sheet will be placed, and the treatment will begin. All sterilization procedures will be strictly followed during patient treatment.

Group 1 (Control Group - No Music Before or During Treatment) In the control group, where patients will not listen to any music at all, initial measurements will include salivary cortisol and oxytocin levels, pulse, body temperature, systolic and diastolic blood pressure, and oxygen saturation upon arrival. In the waiting room, the patient will rest for 15 minutes without listening to any music, although headphones will still be worn to control for external auditory stimuli. Just before the treatment begins, salivary cortisol and oxytocin levels, pulse, body temperature, systolic and diastolic blood pressure, and oxygen saturation will be measured again. The headphones will remain on the ears, but no music will be played during the treatment.In the middle of the procedure, after the caries is removed and the cavity is opened, pulse, blood pressure, oxygen saturation, and body temperature will be re-measured.At the end of the treatment, salivary cortisol and oxytocin levels, pulse, body temperature, systolic and diastolic blood pressure, and oxygen saturation will be measured once more. The MDAS will also be administered.

Group 2 (Patients Will Listen to Music Before Treatment Only; No Music During Dental Treatment) In this experimental group, when the patients arrive at the clinic, their baseline salivary cortisol and oxytocin levels, pulse, body temperature, systolic and diastolic blood pressure, and oxygen saturation will be measured. To prevent exposure to other external sounds, patients will be given headphones and asked to listen to music of their choice for 15 minutes in the waiting room to help them relax. Patients will only listen to music in the waiting room; the music will be stopped before the procedure begins, and no music will be played during the treatment, although the headphones will remain in place. Immediately after music listening in the waiting room and just before the treatment starts, the salivary cortisol and oxytocin levels, pulse, body temperature, systolic and diastolic blood pressure, and oxygen saturation will be re-measured. In the middle of the treatment, after the caries is removed and the cavity is opened, pulse, blood pressure, oxygen saturation, and body temperature will be measured again. At the end of the treatment, to compare the dental anxiety level from arrival to post-treatment, salivary cortisol and oxytocin levels, pulse, body temperature, systolic and diastolic blood pressure, and oxygen saturation will be measured as final assessments. Additionally, the MDAS (Modified Dental Anxiety Scale) will be administered again.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Must be healthy volunteers,
  • Clinical diagnosis of at least one occlusal dental caries
  • Must have moderate dental anxiety

Exclusion Criteria

  • Unhealthy volunteers
  • Teeth with dental cavities in the adjacent teeth where the rubber dam would not be placed
  • Dental caries closer than 1 mm to the pulp tissue

Outcomes

Primary Outcomes

Salivary cortisol level and oxytocin levels

Time Frame: During waiting in the waiting room and dental treatment, an average of one hour

Change of salivary cortisol and oxytocin levels (before-after)

Secondary Outcomes

  • Heart rate(During waiting in the waiting room and dental treatment, an average of one hour)
  • Systolic and diastolic blood pressure(During waiting in the waiting room and dental treatment, an average of one hour)
  • Body temperature(During waiting in the waiting room and dental treatment, an average of one hour)
  • Oxygen saturation(During waiting in the waiting room and dental treatment, an average of one hour)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kıvanc Dulger

Asst Prof

Karadeniz Technical University

Study Sites (2)

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