To Assess the Effect of Binaural Beats on Stress and Motion Artifact in Patients Underwent Myocardial Perfusion Imaging
Design
Controlled Clinical Trial with Parallel Groups, Phase 3, Design of 267 Patients
Settings and conduct
This prospective study comprised 267 patients from April to October 2017 which were divided into three groups: Group I: patients who listened to the music with binaural beat; Group II: patients who listened to the music intervention and Group III: control group.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Intermediate Probability of Coronary Artery Disease According to Framingham Risk Score
Exclusion Criteria: Arrhythmia; Hearing Problems; History of Epilepsy
Intervention groups
Group I: patients who listened to the music with binaural beat; Group II: patients who listened to the music intervention and Group III: control group.
Main outcome variables
stress , heart rate , motion artifact
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140514017684N9
Registration date:2021-06-06, 1400/03/16
Registration timing:retrospective
Last update:2021-06-06, 1400/03/16
Update count:0
Registration date
2021-06-06, 1400/03/16
Registrant information
Name
Mahdi Haghighatafshar
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4835
Email address
afsharm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz university of medical science, Vice chancellor for research
Expected recruitment start date
2017-10-02, 1396/07/10
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
2017-05-10, 1396/02/20
Actual recruitment end date
2017-09-21, 1396/06/30
Trial completion date
2017-09-21, 1396/06/30
Scientific title
To Assess the Effect of Binaural Beats on Stress and Motion Artifact in Patients Underwent Nuclear Imaging
Public title
The Effect of Binaural Beats on Patients Anxiety and Motion Artifacts
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Intermediate Probability of Coronary Artery Disease According to Framingham Risk Score
The Patients Underwent Myocardial Perfusion Imaging
Exclusion criteria:
Arrhythmia
Hearing Problems
History of Epilepsy
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
150
Actual sample size reached:
267
Randomization (investigator's opinion)
N/A
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 Shiraz University of Medical Sciences
Street address
Nuclear Medicine department, Namazi Hospital, Namazi Square
City
Shiraz
Province
Fars
Postal code
7193711351
Approval date
2017-09-23, 1396/07/01
Ethics committee reference number
1396-01-95-15022
Health conditions studied
1
Description of health condition studied
cardiovascular
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Measuring heart rate
Timepoint
Before and after intervention of Imaging
Method of measurement
Heart rate monitor
2
Description
Motion Artifact
Timepoint
During Imaging
Method of measurement
Visually
Secondary outcomes
1
Description
Depression Anxiety Stress
Timepoint
Before and after intervention
Method of measurement
DASS questionnaire
Intervention groups
1
Description
Playing Music with Binaural Beats (Frequency Difference Between the Waves Entering the Left and Right Ear) with Headphone During Imaging, Just 3 min Before Imaging, Headphones Were Located in Both Ears of the Patients Until the End of Imaging (Average 15 min)
Category
Diagnosis
2
Description
Playing ُMusic with Headphone During Imaging, Just 3 min Before Imaging, Headphones Were Located in Both Ears of the Patients Until the End of Imaging (Average 15 min)
Category
Diagnosis
3
Description
Without any Music With or Without Binaural Beats
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra hospital
Full name of responsible person
Nuclear medicine and molecular imaging research center
Street address
Siboye Ave
City
Shiraz
Province
Fars
Postal code
54937-71649
Phone
+98 71 3738 0283
Fax
+98 71 3738 0283
Email
hfcmanager@sums.ac.ir
Web page address
http://hfhc.sums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz university of medical science, Vice chancellor for research
Full name of responsible person
Dr. seyed Basir Hashemi
Street address
Central building of Shiraz University of Medical Science, Karimkhan-e Zand Boulevard
City
Shiraz
Province
Fars
Postal code
71937-11351
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz university of medical science, Vice chancellor for research
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz university of medical science
Full name of responsible person
Nuclear medicine and molecular imaging research center
Position
Expert of the center
Latest degree
Master
Other areas of specialty/work
Nuclear Medicine
Street address
Nuclear Medicine department, Namazi Hospital, Namazi Square
City
Shiraz
Province
Fars
Postal code
11351-71937
Phone
+98 71 3612 5330
Fax
Email
nmmirc@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz university of medical science
Full name of responsible person
Nuclear medicine and molecular imaging research center
Position
Nuclear medicine Specialist
Latest degree
Specialist
Other areas of specialty/work
Nuclear Medicine
Street address
Nuclear Medicine department, Namazi Hospital, Namazi Square
City
Shiraz
Province
Fars
Postal code
11351-71937
Phone
+98 71 3612 5330
Fax
Email
nmmirc@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahdi Haghighatafshar
Position
Nuclear medicine Specialist
Latest degree
Specialist
Other areas of specialty/work
Nuclear Medicine
Street address
Nuclear Medicine department, Namazi Hospital, Namazi Square
City
Shiraz
Province
Fars
Postal code
11351-71937
Phone
+98 71 3612 5330
Email
afsharm@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
all data
When the data will become available and for how long
1 year after publish of article
To whom data/document is available
all researchers
Under which criteria data/document could be used
without any limitation
From where data/document is obtainable
Dr. Mahdi Haghighatafshar
email: afsharm@sums.ac.ir
What processes are involved for a request to access data/document