Investigating the effect of Instrumental Music on Anxiety, Depression and Stress
Design
The clinical trial has two randomized intervention and control groups, and a sample size of 100 people who are divided into two separate groups by simple randomization through a lottery.
Settings and conduct
Clinical study in pre-hospital emergency department in Shiraz city with two intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• Continuous shifts in the EMS
• At least 2 years of work experience
• Consent to participate in the study
• Minimum associate degree
• No use of sedatives and meditation and yoga
Exclusion criteria:
• Not being accompanied
• Long-term leave
• Use of sedatives
• Bereavement of loved ones
• Hearing loss
• Those under medical care for anxiety disorders.
Intervention groups
Intervention group: 5 tracks of instrumental music that the participant in the intervention group must listen to daily for 15 minutes in the morning and 15 minutes at night with headphones or a headset at a moderate volume for one month from the start of the intervention.
Control group: Continues normal daily activities
Main outcome variables
Anxiety, Stress and Depression score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250211064707N1
Registration date:2025-03-05, 1403/12/15
Registration timing:prospective
Last update:2025-03-05, 1403/12/15
Update count:0
Registration date
2025-03-05, 1403/12/15
Registrant information
Name
Esmaeil Rahimi
Name of organization / entity
Emergency Medical Service
Country
Iran (Islamic Republic of)
Phone
+98 71 3875 9310
Email address
e.rahimi@stu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-03-10, 1403/12/20
Expected recruitment end date
2025-03-18, 1403/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of instrumental music on Anxiety, Depression and Stress of Emergency Medical Technicians in Shiraz city
Public title
Investigating the effect of instrumental music on Anxiety, Depression and Stress of Emergency Medical Technicians
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Continuous shifts in the EMS
At least 2 years of work experience
Consent to participate in the study
At least an associate's degree
No use of sedatives and meditation and yoga
Exclusion criteria:
Not accompanying staff
Long-term leave
Use of sedatives
Bereavement
Hearing loss
Those under medical care for anxiety disorders
Age
From 22 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible individuals will be randomly divided into two groups: control and intervention using a simple lottery method.
In order to randomly assign the people selected for the study, Excel software will be used. To do this, the RAND function will be used to assign a random number to each row. For this purpose, we will create a new column in our table, in the first cell of this column (excluding the column title), we will enter the formula =RAND() and copy it to the end of the column and at the end we will sort the random numbers and select the desired number of 50 from the rows.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Shahid Sadoughi University of Medical Sciences
Street address
Foroghi St
City
Farashband
Province
Fars
Postal code
7477119391
Approval date
2024-12-04, 1403/09/14
Ethics committee reference number
IR.SSU.REC.1403.117
Health conditions studied
1
Description of health condition studied
Anxiety, Depression and Stress
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Reduction in Anxiety, Stress, and Depression scores in the intervention group on the DASS21 questionnaire
Timepoint
Assessment of Anxiety, Stress, and Depression scores before the intervention, after one month of intervention, and one month after rest in both intervention and control groups.
Method of measurement
Depression, Anxiety, and Stress Scale (DASS21) Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 5 tracks of instrumental music that the participant in the intervention group must listen to daily for 15 minutes in the morning and 15 minutes at night with headphones or a headset at a moderate volume for one month from the start of the intervention.
Category
Prevention
2
Description
Control group: No intervention is performed and they continue with their normal daily activities.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Emergency 115 in Shiraz
Full name of responsible person
Esmaeil Rahimi
Street address
Foroghi St
City
Farashband
Province
Fars
Postal code
7477119391
Phone
+98 917 815 4542
Email
rahimiesmaeil2@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amir Hushang Mehrparvar
Street address
Emam Hossin St
City
Yazd
Province
Yazd
Postal code
8916188637
Phone
+98 35 3628 8114
Email
dvc.research@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
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
Emergency Medical Service
Full name of responsible person
Esmaeil Rahimi
Position
Emergency Medical Expert
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Foroghi St
City
Farashband
Province
Fars
Postal code
7477119391
Phone
+98 71 3875 9310
Fax
Email
e.rahimi@stu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hossien Tavangar
Position
Associate Professor of Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Safaeieh St
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3824 1751
Email
tavangar11@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Emergency Medical Service
Full name of responsible person
Esmaeil Rahimi
Position
Emergency Medical Expert
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Foroghi St
City
Farashband
Province
Fars
Postal code
7477119391
Phone
+98 71 3875 9310
Fax
Email
e.rahimi@stu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available