NCT03876613

Brief Summary

Anxiety is an important issue in dental care for adults, children and adolescents. Dental anxiety affects 10-20% of adults and 43% of children and adolescents. Dental anxiety often leads to avoiding dental treatment; this can cause serious deterioration of oral and dental health. Such deterioration can significantly increase dental care costs. Therefore, reducing anxiety is important both in terms of patient, physician and cost. Music intervention is a psychological therapy that has many advantages when used in outpatient treatment, including cost-effectiveness, lack of negative physical effects, rapid effect, lack of safety in terms of non-use and lack of concern for recovery. Some types of studies suggested but not tested against each other include classical music, soft rock, calming music, pop, easy listening music, and music of choice. With the contradictory results of various studies, the fact that the distraction of music and its distraction on the reduction of tooth anxiety is not common shows that a more structured study is needed. The lack of precise data on the effects of different music types on anxiety has led to this study.

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 not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

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
7 days until next milestone

First Posted

Study publicly available on registry

March 15, 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 16, 2019

Status Verified

July 1, 2019

Enrollment Period

5 months

First QC Date

March 8, 2019

Last Update Submit

July 13, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of the patients with anxiety

    the type of music that reduces anxiety best and most effectively.

    six month

Study Arms (4)

Turkish music group

ACTIVE COMPARATOR

Rast makam

Behavioral: Different music types

classical western music

ACTIVE COMPARATOR

Vivaldi

Behavioral: Different music types

soft rock music

ACTIVE COMPARATOR

Elvis presley

Behavioral: Different music types

control group

PLACEBO COMPARATOR

No music

Behavioral: Different music types

Interventions

the type of music that reduces anxiety best and most effectively.

Turkish music groupclassical western musiccontrol groupsoft rock music

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \. Molar tooth extraction,
  • years old,
  • Symptomatic

You may not qualify if:

  • Who does not agree to participate in the study,
  • Under 18 years, over 30 years,
  • patients with impaired hearing (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 (3)

  • Almoznino G, Zini A, Sharav Y, Shahar A, Zlutzky H, Haviv Y, Lvovsky A, Aframian DJ. Sleep quality in patients with dental anxiety. J Psychiatr Res. 2015 Feb;61:214-22. doi: 10.1016/j.jpsychires.2014.11.015. Epub 2014 Dec 9.

    PMID: 25529787BACKGROUND
  • Gordon D, Heimberg RG, Tellez M, Ismail AI. A critical review of approaches to the treatment of dental anxiety in adults. J Anxiety Disord. 2013 May;27(4):365-78. doi: 10.1016/j.janxdis.2013.04.002. Epub 2013 Apr 13.

  • Shim YS, Kim AH, Jeon EY, An SY. Dental fear & anxiety and dental pain in children and adolescents; a systemic review. J Dent Anesth Pain Med. 2015 Jun;15(2):53-61. doi: 10.17245/jdapm.2015.15.2.53. Epub 2015 Jun 30.

Study Officials

  • ilke kupeli

    Erzincan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ufuk kuyrukluyıldız

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assist. prof.

Study Record Dates

First Submitted

March 8, 2019

First Posted

March 15, 2019

Study Start

July 15, 2019

Primary Completion

December 15, 2019

Study Completion

January 15, 2020

Last Updated

July 16, 2019

Record last verified: 2019-07