NCT03872934

Brief Summary

A general term, dental anxiety, is defined as fear or an abnormal concern to visit the dentist for unwanted concerns about preventive care and dental procedures. anxiety; dental examinations or treatment can be prevented or postponed. This delay in dentistry typically leads to much more serious dental problems, often leading to more expensive, more invasive and possibly emergency treatment. Therefore, reducing anxiety is important both in terms of patient, physician and cost.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

March 8, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 13, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

July 15, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
Last Updated

July 15, 2019

Status Verified

July 1, 2019

Enrollment Period

5 months

First QC Date

March 8, 2019

Last Update Submit

July 11, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Corah's dental anxiety scale

    the type of music that reduces anxiety in patients undergoing implant surgery.

    six month

Study Arms (4)

Turkish music group

Turkish music group (Saba or rast makam)

Behavioral: implant anxiety

classical western music

classical western music (vivaldi)

Behavioral: implant anxiety

soft rock music

soft rock music (elvis)

Behavioral: implant anxiety

control group (group not listening music)

control

Behavioral: implant anxiety

Interventions

implant anxietyBEHAVIORAL

to determine the type of music that reduces anxiety in patients undergoing implant surgery.

Turkish music groupclassical western musiccontrol group (group not listening music)soft rock music

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Eighty patients aged 40-70 years will undergo elective implant surgery.

You may qualify if:

  • Will undergo elective implant surgery,
  • between 40-70 years

You may not qualify if:

  • Who does not agree to participate in the study,
  • Under 40, over 70 years,
  • Patients with ear disorders (ie, not suitable for musical intervention),
  • arrhythmia
  • patients with physical condition III or higher (American Society of Anesthesiologists)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Miyata K, Odanaka H, Nitta Y, Shimoji S, Kanehira T, Kawanami M, Fujisawa T. Music before Dental Surgery Suppresses Sympathetic Activity Derived from Preoperative Anxiety: A Randomized Controlled Trial. JDR Clin Trans Res. 2016 Jul;1(2):153-162. doi: 10.1177/2380084416650613.

  • Bodner E, Iancu I. Recalling the threat: dental anxiety in patients waiting for dental surgery. Isr J Psychiatry Relat Sci. 2013;50(1):61-6.

  • Thoma MV, Zemp M, Kreienbuhl L, Hofer D, Schmidlin PR, Attin T, Ehlert U, Nater UM. Effects of Music Listening on Pre-treatment Anxiety and Stress Levels in a Dental Hygiene Recall Population. Int J Behav Med. 2015 Aug;22(4):498-505. doi: 10.1007/s12529-014-9439-x.

  • Wright H. The Correlation of Classical, Jazz, and Pop Music to a Reduction of Dental Anxiety Experienced by Adult Patients. 2018.

    RESULT

Related Links

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • ilke kupeli

    Erzincan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assist. prof.

Study Record Dates

First Submitted

March 8, 2019

First Posted

March 13, 2019

Study Start

July 15, 2019

Primary Completion

December 15, 2019

Study Completion

January 15, 2020

Last Updated

July 15, 2019

Record last verified: 2019-07