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Effects of "Music for the Mind" on Pre-operative Anxiety in Dentistry

Primary Purpose

Dental Anxiety

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Music
Sponsored by
Azad University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Anxiety focused on measuring Music, dental anxiety, "music for the mind", mozart, iranian traditional music

Eligibility Criteria

17 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • need for dental treatments

Exclusion Criteria:

  • usage of anxiety drugs
  • usage of psychoactive drugs
  • emergency cases

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Experimental

    Arm Label

    Silence

    Music for the mind

    Mozart music

    Iranian traditional music

    Arm Description

    the subjects received 10 minutes of silence through headphone

    Outcomes

    Primary Outcome Measures

    STAI Inventory
    The level of anxiety was measured by STAI Inventory index immediately after the intervention

    Secondary Outcome Measures

    Heart rate
    The index was measured before and after the intervention
    Systolic blood pressure
    The index was measured before and after the intervention
    Diastolic blood pressure
    The index was measured before and after the intervention

    Full Information

    First Posted
    June 14, 2012
    Last Updated
    June 18, 2012
    Sponsor
    Azad University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01622374
    Brief Title
    Effects of "Music for the Mind" on Pre-operative Anxiety in Dentistry
    Official Title
    a Randomized Controlled Clinical Trial on the Effects of "Music for the Mind" on Pre-operative Anxiety in Dentistry
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2011 (undefined)
    Primary Completion Date
    March 2011 (Actual)
    Study Completion Date
    April 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Azad University of Medical Sciences

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To examine the pre-operative effect of music for the mind compared to some other styles of music in patients undergoing dental procedures.
    Detailed Description
    120 patients were sequentially assigned to four groups of 30 subjects. the music groups received Music for the mind, Iranian traditional music and Mozart music through headphone for ten minutes prior to dental procedures, and the control group received silence through headphone. anxiety score and pulse rate and blood pressure were measured before and after receiving music

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Anxiety
    Keywords
    Music, dental anxiety, "music for the mind", mozart, iranian traditional music

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Silence
    Arm Type
    Active Comparator
    Arm Description
    the subjects received 10 minutes of silence through headphone
    Arm Title
    Music for the mind
    Arm Type
    Experimental
    Arm Title
    Mozart music
    Arm Type
    Experimental
    Arm Title
    Iranian traditional music
    Arm Type
    Experimental
    Intervention Type
    Behavioral
    Intervention Name(s)
    Music
    Other Intervention Name(s)
    Music for the mind, Mozart Music, Iranian Music
    Intervention Description
    Ten minutes of music or silence were applied prior to dental procedures
    Primary Outcome Measure Information:
    Title
    STAI Inventory
    Description
    The level of anxiety was measured by STAI Inventory index immediately after the intervention
    Time Frame
    5 minutes
    Secondary Outcome Measure Information:
    Title
    Heart rate
    Description
    The index was measured before and after the intervention
    Time Frame
    30 seconds
    Title
    Systolic blood pressure
    Description
    The index was measured before and after the intervention
    Time Frame
    30 seconds
    Title
    Diastolic blood pressure
    Description
    The index was measured before and after the intervention
    Time Frame
    30 seconds

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    17 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: need for dental treatments Exclusion Criteria: usage of anxiety drugs usage of psychoactive drugs emergency cases
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Aminpasha Samadian, DDS
    Organizational Affiliation
    Azad university of medical science
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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    Effects of "Music for the Mind" on Pre-operative Anxiety in Dentistry

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