Protocol summary

Summary
Objective: To investigate the effect of music therapy on stress of operating room personnel working in Shiraz University of Medical Sciences. Sampling: 30 personnel are randomly selected and randomly divided into two groups. Inclusion criteria: Scrub personnel; elective surgery; scoring 31 and above from Spill Berger stress questionnaire. Exclusion criteria: Failure to complete questionnaires |; history of new crisis such as : death of first degree relatives, divorce or parent's divorce in the last 6 months, opium addiction, history of participation in the problem-solving skill training and stress management techniques course and yoga course in the last 6 months; mental illness, using psychotropic drugs. In the intervention group participants listen to the instrumental music for two weeks before the start of operation and stress before and after music therapy is measured by the Spiel Berger Job Stress Questionnaire. In the control group there is no intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017052319470N58
Registration date: 2017-06-10, 1396/03/20
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-06-10, 1396/03/20
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vic Chancellor for Research, Shiraz University of Medical Sciences
Expected recruitment start date
2017-06-02, 1396/03/12
Expected recruitment end date
2017-09-03, 1396/06/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To investigate the effect of music therapy on stress of operating room personnel working
Public title
To investigate the effect of music therapy on stress of operating room personnel working
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Scrub personnel; elective surgery; scoring 31 and above from Spill Berger stress questionnaire. Exclusion criteria: Failure to complete questionnaires |; history of new crisis such as : death of first degree relatives, divorce or parent's divorce in the last 6 months, opium addiction, history of participation in the problem-solving skill training and stress management techniques course and yoga course in the last 6 months; mental illness, using psychotropic drugs.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 31
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 Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Postal code
Approval date
2017-05-19, 1396/02/29
Ethics committee reference number
IR.SUMS.REC.1395.177

Health conditions studied

1

Description of health condition studied
stress
ICD-10 code
R45.7
ICD-10 code description
State of emotional shock and stress, unspecified

Primary outcomes

1

Description
stress
Timepoint
before and after music therapy
Method of measurement
Spiel Berger Job Stress Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
In the intervention group participants listen to the instrumental music for two weeks before the start of operation and stress before and after music therapy is measured by the Spiel Berger Job Stress Questionnaire.
Category
Diagnosis

2

Description
There is no intervention in the control group.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Street address
Namazi squre, Namazi Hospital
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr Seed Basir Hashemi
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mostafa Moazam Fard
Position
Nurse
Other areas of specialty/work
Street address
Nursing Department, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
masihifarzaneh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz Universiy of Medical Sciences
Full name of responsible person
Mostafa Moazam Fard
Position
Nurse
Other areas of specialty/work
Street address
Nursing Department, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
masihifarzaneh@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
Farzaneh Masihi
Position
MS in English teaching ,BS in anesthesia/English Consultant
Other areas of specialty/work
Street address
5th floor, Mohammad Rasul Allah Research Tower, Khalili Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
masihifarzaneh@yahoo.com
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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