Back to results

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

Primary Purpose

Dental Anxiety, Music, Physical Stress

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

music listening

About this trial

This is an interventional supportive care trial for Dental Anxiety focused on measuring dental anxiety, music

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Karadeniz Technical University Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control group

experimental group

Arm Description

In the control group there will be no music listening

In this group patients will listen to music while their dental treatments are being made.

Outcomes

Primary Outcome Measures

Salivary cortisol level

Change of salivay cortisol level (before-after)

Vital anxiety signs

Change of heart rate, body temperature, systolic and diastolic blood pressure and oxygen saturation measurements

Secondary Outcome Measures

Modified dental anxiety questionnaire

Modified dental anxiety questionnaire will be applied to participants after finishing dental treatment

Full Information

NCT ID

NCT04932759

First Posted

June 5, 2021

Last Updated

October 3, 2023

Sponsor

Karadeniz Technical University

1. Study Identification

Unique Protocol Identification Number

NCT04932759

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

January 10, 2021 (Actual)

Primary Completion Date

December 10, 2021 (Actual)

Study Completion Date

January 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Karadeniz Technical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Anxiety, Music, Physical Stress

Keywords

dental anxiety, music

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Control and study group

Masking

None (Open Label)

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

control group

Arm Type

No Intervention

Arm Description

In the control group there will be no music listening

Arm Title

experimental group

Arm Type

Experimental

Arm Description

In this group patients will listen to music while their dental treatments are being made.

Intervention Type

Behavioral

Intervention Name(s)

music listening

Intervention Description

music listening during dental treatment

Primary Outcome Measure Information:

Title

Salivary cortisol level

Description

Change of salivay cortisol level (before-after)

Time Frame

Before-after

Title

Vital anxiety signs

Description

Change of heart rate, body temperature, systolic and diastolic blood pressure and oxygen saturation measurements

Time Frame

Before-after

Secondary Outcome Measure Information:

Title

Modified dental anxiety questionnaire

Description

Modified dental anxiety questionnaire will be applied to participants after finishing dental treatment

Time Frame

Before-after

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

KIVANÇ DÜLGER

Organizational Affiliation

Asst Prof

Official's Role

Study Director

Facility Information:

Facility Name

Karadeniz Technical University Faculty of Dentistry

City

Trabzon

ZIP/Postal Code

61080

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

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

Citations:

PubMed Identifier

32401941

Citation

Aravena PC, Almonacid C, Mancilla MI. Effect of music at 432 Hz and 440 Hz on dental anxiety and salivary cortisol levels in patients undergoing tooth extraction: a randomized clinical trial. J Appl Oral Sci. 2020;28:e20190601. doi: 10.1590/1678-7757-2019-0601. Epub 2020 May 11.

Results Reference

background

PubMed Identifier

26573456

Citation

Mejia-Rubalcava C, Alanis-Tavira J, Mendieta-Zeron H, Sanchez-Perez L. Changes induced by music therapy to physiologic parameters in patients with dental anxiety. Complement Ther Clin Pract. 2015 Nov;21(4):282-6. doi: 10.1016/j.ctcp.2015.10.005. Epub 2015 Oct 27.

Results Reference

background

PubMed Identifier

27886431

Citation

Bradt J, Teague A. Music interventions for dental anxiety. Oral Dis. 2018 Apr;24(3):300-306. doi: 10.1111/odi.12615. Epub 2017 Jan 5.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs