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

Sponsor

Karadeniz Technical University (Other)

Overall Status

Completed

CT.gov ID

NCT04932759

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

5.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Anxiety Music Physical Stress	Behavioral: music listening	N/A

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, pulse, 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. While starting the treatment, the participants will listen to music in experimental group. In control group the participant will not listen to music. Pulse, 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, pulse, 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 Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Control and study groupControl and study group

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jan 10, 2021

Actual Primary Completion Date :

Dec 10, 2021

Actual Study Completion Date :

Jan 10, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Salivary cortisol level [1 hour]
Change of salivay cortisol level (before-after)
Vital anxiety signs [1 hour]
Change of pulse, body temperature, systolic and diastolic blood pressure and oxygen saturation measurements

Secondary Outcome Measures

Modified dental anxiety questionnaire [1 minute]
Modified dental anxiety questionnaire will be applied to participants after finishing dental treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Must be healthy volunteers, clinical diagnosis of one dental caries, must have moderate dental anxiety

Exclusion Criteria:Unhealthy, smoking

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karadeniz Technical University Faculty of Dentistry	Trabzon		Turkey	61080

Sponsors and Collaborators

Karadeniz Technical University

Investigators

Study Director: KIVANÇ DÜLGER, Asst Prof

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Kıvanc Dulger, Assistant Professor, Karadeniz Technical University

ClinicalTrials.gov Identifier:

NCT04932759

Other Study ID Numbers:

2020-41

First Posted:

Jun 21, 2021

Last Update Posted:

Apr 7, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Kıvanc Dulger, Assistant Professor, Karadeniz Technical University

dental anxiety

music

Additional relevant MeSH terms:

Anxiety Disorders

Study Results

No Results Posted as of Apr 7, 2022