Protocol summary

Study aim
The effect of music on emergency medical technicians (EMT) stress during work shift
Design
A clinical trial with a control group, with parallel groups, one blind strain, randomized, on 90 emergency medical personnel, random allocation with a Balanced (permuted) block randomization
Settings and conduct
The location of the present study will be the pre-hospital emergency centers of Kermanshah. Operational personnel in the intervention groups, after completing the occupational stress questionnaire, at the beginning of the shift and after the mission, in 2 groups, they will play music without words or the technician's favorite music for 25 minutes and complete the occupational stress questionnaire again. do The control group completed the questionnaires at the same time and did not receive any intervention.The implementer of the intervention and the evaluator are two separate people, and the evaluator as well as the statistical consultant do not know the arrangement of the people in the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: - Pre-hospital emergency operative technician - Willingness to participate in the study - Interested in music - Has an associate's degree - bachelor's degree in pre-hospital emergency medicine or master's degree in nursing with pre-hospital emergency medicine basis Exclusion criteria: - Having thyroid diseases - History of active psychiatric diseases or taking psychiatric drugs - hearing disorder
Intervention groups
The first intervention group: playing music without words at the beginning of the work shift and after returning from the mission. The second intervention group: Playing the technician's favorite music at the beginning of the work shift and after returning from the mission. The third intervention group (control): performing routine and daily tasks
Main outcome variables
Job stress level

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240724062537N1
Registration date: 2024-08-07, 1403/05/17
Registration timing: prospective

Last update: 2024-08-07, 1403/05/17
Update count: 0
Registration date
2024-08-07, 1403/05/17
Registrant information
Name
Afshin Goodarzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3720 1343
Email address
afshingoodarzy@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2025-01-19, 1403/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of music on emergency medical technicians (EMT) stress during work shift
Public title
The effect of music on stress
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Pre-hospital emergency operative technician Associate's degree, expert or master's degree in emergency medicine Willingness to participate in the study Interested in music
Exclusion criteria:
Suffering from thyroid diseases, including hyperthyroidism or hypothyroidism No history of active psychiatric diseases or taking psychiatric drugs Hearing impairment
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the available sampling method will be used with the random allocation approach of "creating a random sequence using the limited randomization method" with the title "block randomization". In this way, the "number of 30 blocks" will be implemented with blocks of 3 and allocation ratio 1:1:1. In this way, the letter A will be assigned to the intervention/first test group, the letter B will be assigned to the intervention/second test group, and the letter C will be assigned to the control group, and finally in blocks of three with the letters A, B, and C, ABC, ACB modes will be assigned. , CAB and ... are assigned. Randomization is done using online randomization. Sequentially numbered, sealed opaque envelopes are used to hide random allocation.
Blinding (investigator's opinion)
Single blinded
Blinding description
The outcome assessor as well as the statistical consultant will be unaware of the type of intervention
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
No.207 , East Nasim St., Sanbal St., Sadra Township, Kermanshah City
City
Kermanshah
Province
Kermanshah
Postal code
6717864817
Approval date
2024-07-24, 1403/05/03
Ethics committee reference number
IR.KUMS.REC.1403.205

Health conditions studied

1

Description of health condition studied
stress level
ICD-10 code
F43.0
ICD-10 code description
Acute stress reaction

Primary outcomes

1

Description
Stress level in occupational stress questionnaire(HSE)
Timepoint
Before the intervention (at the beginning of the work shift) and after the intervention and returning from the mission
Method of measurement
occupational stress questionnaire(HSE)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: At the beginning of the work shift, playing the song without words (Storias by Albins) for 25 minutes. After returning from the mission, playing a song without words (Serenade by Schubert) for 25
Category
Other

2

Description
Intervention group: At the beginning of the work shift, playing the technician's favorite music for 25 minutes. After returning from a mission, play the technician's favorite music for 25 minutes
Category
Other

3

Description
Control group: Doing routine and daily tasks
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Pre-hospital emergency medical centers affiliated to Kermanshah University of Medical Sciences
Full name of responsible person
Afshin goodarzi
Street address
No. 207, 102 Alley, Shabbo Street, Nasim East, Sadra Town, Kermanshah City
City
Kermanshahن
Province
Kermanshah
Postal code
6717864817
Phone
+98 83 3720 1343
Email
afshingoodarzy@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Cyrus of Galilee
Street address
Building No. 2, Research and Technology Vice-Chancellor, Shahid Beheshti Boulevard, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Phone
+98 83 3838 4185
Email
cjalili@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Afshin Goodarzi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No. 207, 102 Alley, Shabbo Street, Nasim East Street, Sadra Town, Kermanshah City
City
Kermanshah
Province
Kermanshah
Postal code
9717864817
Phone
+98 83 3720 1343
Email
afshingoodarzy@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Afshin Goodarzi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No. 207, 102 Alley, Shabbo Street, Nasim East Street, Sadra Town, Kermanshah City
City
Kermanshah
Province
Kermanshah
Postal code
6717864817
Phone
+98 83 3720 1343
Email
afshingoodarzy@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Afshin Goodarzi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No. 207, 102 Alley, Shabbo Street, Nasim East Street, Sadra Town, Kermanshah City
City
Kermanshah
Province
Kermanshah
Postal code
6717864817
Phone
+98 83 3720 1343
Email
afshingoodarzy@yahoo.com

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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
- Conducting new statistical analyzes based on researchers' needs - Report the result of research in new studies
From where data/document is obtainable
Corresponding author: Afshin Goodarzi as the scientific officer of the study How to respond: email E-mail: afshingoodarzi@yahoo.com
What processes are involved for a request to access data/document
After sending an email from the requester and checking the purpose of the request, the data will be sent within a maximum period of 15 days
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