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

June 18, 2012 updated by: Aminpasha Samadian, Azad University of Medical Sciences

a Randomized Controlled Clinical Trial on the Effects of "Music for the Mind" on Pre-operative Anxiety in Dentistry

To examine the pre-operative effect of music for the mind compared to some other styles of music in patients undergoing dental procedures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • need for dental treatments

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Silence
the subjects received 10 minutes of silence through headphone
Behavioral: Music
Ten minutes of music or silence were applied prior to dental procedures
Other Names:
  • Music for the mind
  • Mozart Music
  • Iranian Music
Experimental: Music for the mind
Behavioral: Music
Ten minutes of music or silence were applied prior to dental procedures
Other Names:
  • Music for the mind
  • Mozart Music
  • Iranian Music
Experimental: Mozart music
Behavioral: Music
Ten minutes of music or silence were applied prior to dental procedures
Other Names:
  • Music for the mind
  • Mozart Music
  • Iranian Music
Experimental: Iranian traditional music
Behavioral: Music
Ten minutes of music or silence were applied prior to dental procedures
Other Names:
  • Music for the mind
  • Mozart Music
  • Iranian Music

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
STAI Inventory
Time Frame: 5 minutes
The level of anxiety was measured by STAI Inventory index immediately after the intervention
5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate
Time Frame: 30 seconds
The index was measured before and after the intervention
30 seconds
Systolic blood pressure
Time Frame: 30 seconds
The index was measured before and after the intervention
30 seconds
Diastolic blood pressure
Time Frame: 30 seconds
The index was measured before and after the intervention
30 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azad University of Medical Sciences

Investigators

  • Study Chair: Aminpasha Samadian, DDS, Azad university of medical science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

June 14, 2012

First Submitted That Met QC Criteria

June 18, 2012

First Posted (Estimate)

June 19, 2012

Study Record Updates

Last Update Posted (Estimate)

June 19, 2012

Last Update Submitted That Met QC Criteria

June 18, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Aminpasha_CT0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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