Protocol summary

Summary
Heart rate is the result of interaction between sympathetic and parasympathetic fibers and sinoatrial node pulse-maker properties. Therefore, measuring heart rate variability (HRV) is a non-invasive method to assess cardiac autonomic nervous system. Various factors are able to influence cardiac autonomic nervous system and in this way they lead to modify HRV indexes. Various studies demonstrated that music is one of the factors, which can influence cardiac autonomic modulation. The purpose of this study is to explore the effect of Iranian Traditional music on HRV indexes. The design of this study determines that meanwhile each subject (of the total subjects n=15) has to listen to music or white noise with a 15 minute interval, ECG lead II continuously is recorded for five min. Then, time and frequency domains of heart rate variability criteria are calculated. The inclusion criteria are being male and age of 19 to 24 and the exclusion criteria are chronic diseases (such as diabetes, hypertension, epilepsy, etc.), smokers, and chronic medication consumers. The interventions of the study include the Iranian traditional music Šur and Homāyoun Dastgāh and the white noise. The mean and standard deviation of sequential R-R intervals are the primary outcomes of the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013011011236N3
Registration date: 2016-12-09, 1395/09/19
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-12-09, 1395/09/19
Registrant information
Name
Esmaeil Akbari
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 12 1223 0855
Email address
akbari_esmaeil@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy for Research, Mazandaran University of Medical Sciences
Expected recruitment start date
2016-12-10, 1395/09/20
Expected recruitment end date
2017-01-10, 1395/10/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Modulating effect of Iranian traditional music in Šur and Homāyoun Dastgāh on cardiac sympathovagal balance
Public title
Effect of Iranian traditional music on cardiac sympathovagal balance
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria: female; ages between 19-24 years old. Exclusion criteria: chronic disease (i.e. diabetes mellitus, hypertension, epilepsy and etc); smoker; under regular medication.
Age
From 19 years old to 24 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 19
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Department of Physiology, School of Medicine, Mazandaran University of Medical Sciences, Sari, Iran
City
Sari
Postal code
Approval date
2015-07-07, 1394/04/16
Ethics committee reference number
IR.MAZUMS.REC.94.1257

Health conditions studied

empty

Primary outcomes

1

Description
RR interval
Timepoint
before and after hearing of white noise or music
Method of measurement
Mean and Standard deviation of Time domain of ECG

Secondary outcomes

1

Description
High frequency power spectrum
Timepoint
before and after hearing of white noise or music
Method of measurement
Frequency domain analysis of ECG

2

Description
Low frequency power spectrum
Timepoint
before and after hearing of white noise or music
Method of measurement
Frequency domain analysis of ECG

Intervention groups

1

Description
White noise
Category
Other

2

Description
music
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Medicine, Mazandaran University of Medical Sciences
Full name of responsible person
Esmaeil Akbari
Street address
City
sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy for Research, Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad-ali Enayati
Street address
Deputy for Research, Moalem Square, Buil. No 2, Mazandaran University of Medical Sciences, Sari, Iran.
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy for Research, Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Department of Physiology, School of Medicine, Mazandaran University of Medical Sciences, Sari
Full name of responsible person
Esmaeil Akbari
Position
Associate Professor
Other areas of specialty/work
Street address
Department of Physiology, School of Medicine, Mazandaran University of Medical Sciences, Sari, Iran Sari
City
Sari
Postal code
Phone
+98 11 4422 1919
Fax
Email
Akbari_esmaeil@mazums.ac.ir; Akbari_esmaeil@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Physiology, School of Medicine, Mazandaran University of Medical Sciences, Sari
Full name of responsible person
Esmaeil Akbari
Position
Associate Professor
Other areas of specialty/work
Street address
Department of Physiology, School of Medicine, Mazandaran University of Medical Sciences, Sari
City
Sari
Postal code
Phone
+98 11 4422 1919
Fax
Email
Akbari_esmaeil@mazums.ac.ir; Akbari_esmaeil@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Department of Physiology, School of Medicine, Mazandaran University of Medical Sciences, Sari
Full name of responsible person
Esmaeil Akbari
Position
Associate Professor
Other areas of specialty/work
Street address
Department of Physiology, School of Medicine, Mazandaran University of Medical Sciences, Sari
City
Sari
Postal code
Phone
+98 11 4422 1919
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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