NCT01622374

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 19, 2012

Completed
Last Updated

June 19, 2012

Status Verified

June 1, 2012

Enrollment Period

2 months

First QC Date

June 14, 2012

Last Update Submit

June 18, 2012

Conditions

Dental Anxiety

Keywords

Musicdental anxiety"music for the mind"mozartiranian traditional music

Outcome Measures

Primary Outcomes (1)

  • STAI Inventory

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

    5 minutes

Secondary Outcomes (3)

  • Heart rate

    30 seconds

  • Systolic blood pressure

    30 seconds

  • Diastolic blood pressure

    30 seconds

Study Arms (4)

Silence

ACTIVE COMPARATOR

the subjects received 10 minutes of silence through headphone

Behavioral: Music

Music for the mind

EXPERIMENTAL
Behavioral: Music

Mozart music

EXPERIMENTAL
Behavioral: Music

Iranian traditional music

EXPERIMENTAL
Behavioral: Music

Interventions

MusicBEHAVIORAL

Ten minutes of music or silence were applied prior to dental procedures

Also known as: Music for the mind, Mozart Music, Iranian Music
Iranian traditional musicMozart musicMusic for the mindSilence

Eligibility Criteria

Age17 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • need for dental treatments

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Aminpasha Samadian, DDS

    Azad university of medical science

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
researcher in Azad University of Medical Sciences

Study Record Dates

First Submitted

June 14, 2012

First Posted

June 19, 2012

Study Start

January 1, 2011

Primary Completion

March 1, 2011

Study Completion

April 1, 2011

Last Updated

June 19, 2012

Record last verified: 2012-06