The Effect Of Music Listened By Patients With Moderate Dental Anxiety During The Restoration Of Occlusal Caries

October 3, 2023 updated by: Kıvanc Dulger, Karadeniz Technical University

Investigation Of The Effect Of Music Listened By Patients With Moderate Dental Anxiety During The Restoration Of Posterior Occlusal Dental Caries

It is aimed to evaluate the effect of music listened by patients with moderate dental anxiety during the restoration of posterior occlusal dental caries on vital signs of the participants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will be applied on 70 patients; 35 patients will be in the control group (the group not listening to music during treatment), 35 patients will be in the experimental group (the group listening to music during treatment).

Modified Dental Anxiety Scale consisting of 5 questions will be applied to the participants who come to the clinic and have occlusal dental caries in the posterior region. The participants whose scores are between 10-18 according to this scale will be included in the study. One occlusal tooth decay will be treated. Before starting treatment, saliva cortisol levels, heart rate, body temperature, systolic and diastolic blood pressure and oxygen saturation measurements will be made. The participants will be asked to spit in sterile plastic containers for saliva cortisol measurement. During dental treatment, the participants will listen to music in experimental group. In control group the participant will not listen to music. Heart rate, body temperature, systolic and diastolic blood pressure and oxygen saturation measurements will be repeated in the middle of the treatment (without going through the restoration phase when the cavity is opened). Saliva cortisol levels, heart rate, body temperature, systolic and diastolic blood pressure and oxygen saturation measurements will be repeated when the treatment is completed. The questionnaire containing the modified dental anxiety scale will be re-administered to the participants.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Trabzon, Turkey, 61080
        • Karadeniz Technical University Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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, and dental caries closer than 1 mm to the pulp tissue were not included in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
In the control group there will be no music listening
Experimental: experimental group
In this group patients will listen to music while their dental treatments are being made.
Behavioral: music listening
music listening during dental treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Salivary cortisol level
Time Frame: Before-after
Change of salivay cortisol level (before-after)
Before-after
Vital anxiety signs
Time Frame: Before-after
Change of heart rate, body temperature, systolic and diastolic blood pressure and oxygen saturation measurements
Before-after

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified dental anxiety questionnaire
Time Frame: Before-after
Modified dental anxiety questionnaire will be applied to participants after finishing dental treatment
Before-after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karadeniz Technical University

Investigators

  • Study Director: KIVANÇ DÜLGER, Asst Prof

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2021

Primary Completion (Actual)

December 10, 2021

Study Completion (Actual)

January 10, 2022

Study Registration Dates

First Submitted

June 5, 2021

First Submitted That Met QC Criteria

June 12, 2021

First Posted (Actual)

June 21, 2021

Study Record Updates

Last Update Posted (Actual)

October 5, 2023

Last Update Submitted That Met QC Criteria

October 3, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-41

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

After the completing of the study, the data will be written as a research article.

IPD Sharing Time Frame

After completing the study and analyzing the results

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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