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Different Music Types in Reducing Dental Anxiety in Young People

Primary Purpose

Dental Anxiety

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Different music types
Sponsored by
Erzincan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Anxiety

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 3. Molar tooth extraction,
  • 18-30 years old,
  • Symptomatic

Exclusion Criteria:

  • 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    Turkish music group

    classical western music

    soft rock music

    control group

    Arm Description

    Rast makam

    Vivaldi

    Elvis presley

    No music

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    March 8, 2019
    Last Updated
    July 13, 2019
    Sponsor
    Erzincan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03876613
    Brief Title
    Different Music Types in Reducing Dental Anxiety in Young People
    Official Title
    Comparison of Different Music Types in Reducing Dental Anxiety in Young People Undergoing Third Molar Tooth Surgery - A Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 15, 2019 (Anticipated)
    Primary Completion Date
    December 15, 2019 (Anticipated)
    Study Completion Date
    January 15, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Erzincan University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Turkish music group
    Arm Type
    Active Comparator
    Arm Description
    Rast makam
    Arm Title
    classical western music
    Arm Type
    Active Comparator
    Arm Description
    Vivaldi
    Arm Title
    soft rock music
    Arm Type
    Active Comparator
    Arm Description
    Elvis presley
    Arm Title
    control group
    Arm Type
    Placebo Comparator
    Arm Description
    No music
    Intervention Type
    Behavioral
    Intervention Name(s)
    Different music types
    Intervention Description
    the type of music that reduces anxiety best and most effectively.
    Primary Outcome Measure Information:
    Title
    Number of the patients with anxiety
    Description
    the type of music that reduces anxiety best and most effectively.
    Time Frame
    six month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 3. Molar tooth extraction, 18-30 years old, Symptomatic Exclusion Criteria: 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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    ilke kupeli
    Phone
    +905555485632
    Email
    ilkeser2004@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    ufuk kuyrukluyıldız
    Phone
    +905555485632
    Email
    drufuk2001@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    ilke kupeli
    Organizational Affiliation
    Erzincan University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    25529787
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23746494
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    28879259
    Citation
    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.
    Results Reference
    result

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    Different Music Types in Reducing Dental Anxiety in Young People

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