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

Dental Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01622374
• Other study ID #: Aminpasha_CT0001
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 14, 2012
• Last updated: June 18, 2012
• Start date: January 2011
• Est. completion date: April 2011

Study information

• Verified date: June 2012
• Source: Azad University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 17 Years to 70 Years

Eligibility

Inclusion Criteria:

• need for dental treatments

Exclusion Criteria:

• usage of anxiety drugs

• usage of psychoactive drugs

• emergency cases

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anxiety Disorders
• Dental Anxiety

Intervention

Behavioral:
• Music
Ten minutes of music or silence were applied prior to dental procedures

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azad University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	STAI Inventory	The level of anxiety was measured by STAI Inventory index immediately after the intervention	5 minutes	No
Secondary	Heart rate	The index was measured before and after the intervention	30 seconds	No
Secondary	Systolic blood pressure	The index was measured before and after the intervention	30 seconds	No
Secondary	Diastolic blood pressure	The index was measured before and after the intervention	30 seconds	No