NCT04932759

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 21, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2022

Completed
Last Updated

October 5, 2023

Status Verified

October 1, 2023

Enrollment Period

11 months

First QC Date

June 5, 2021

Last Update Submit

October 3, 2023

Conditions

Keywords

dental anxietymusic

Outcome Measures

Primary Outcomes (2)

  • Salivary cortisol level

    Change of salivay cortisol level (before-after)

    Before-after

  • Vital anxiety signs

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

    Before-after

Secondary Outcomes (1)

  • Modified dental anxiety questionnaire

    Before-after

Study Arms (2)

control group

NO INTERVENTION

In the control group there will be no music listening

experimental group

EXPERIMENTAL

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

Behavioral: music listening

Interventions

music listeningBEHAVIORAL

music listening during dental treatment

experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karadeniz Technical University Faculty of Dentistry

Trabzon, 61080, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 32401941BACKGROUND
  • 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.

    PMID: 26573456BACKGROUND
  • 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.

    PMID: 27886431BACKGROUND

Study Officials

  • KIVANÇ DÜLGER

    Asst Prof

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Control and study group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 5, 2021

First Posted

June 21, 2021

Study Start

January 10, 2021

Primary Completion

December 10, 2021

Study Completion

January 10, 2022

Last Updated

October 5, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

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

Locations