Protocol summary

Study aim
The purpose of this study was to Comparing the effects of music and Pilates exercise on fatigue in nurses
Design
The participants were selected 76 nurse working in hospitals of Ziaei (located in Ardakan city) and Imam Jafar-Sadegh (located in Meybod city).
Settings and conduct
Participants were divided in two groups; 38 nurses in music and 38 nurses in Pilate's group.
Participants/Inclusion and exclusion criteria
A nurse has a bachelor's degree in nursing or higher Have at least one year of work experience Female Fatigue rating 5 and 5 up Inclination to participate in research and conscientious consent to enter the study
Intervention groups
Interventions were performed times a week for six weeks. The music group listened to music through headphones for 20 minutes a day and listened to it for three weeks a week for six weeks. The Pilates exercise group trained 60 minutes each time in the presence of an instructor and researcher for 6 weeks, 3 times per week.
Main outcome variables
Fatigue Severity Scale (FSS) Questionnaire is completed first and one week after the end of the intervention.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181002041211N1
Registration date: 2018-10-17, 1397/07/25
Registration timing: retrospective

Last update: 2018-10-17, 1397/07/25
Update count: 0
Registration date
2018-10-17, 1397/07/25
Registrant information
Name
Ameneh Jahanbani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1000
Email address
jahanbaniardekani.a@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-21, 1397/02/31
Expected recruitment end date
2018-07-02, 1397/04/11
Actual recruitment start date
2018-05-21, 1397/02/31
Actual recruitment end date
2018-07-02, 1397/04/11
Trial completion date
2018-07-09, 1397/04/18
Scientific title
Comparing the effects of music and Pilates exercise on fatigue in nurses
Public title
Comparing the effects of music and Pilates exercise on fatigue in nurses
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
A nurse has a bachelor's degree in nursing or higher Have at least one year of work experience Female Fatigue rating 5 and 5 up Inclination to participate in research and conscientious consent to enter the study
Exclusion criteria:
Age
From 23 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 76
Actual sample size reached: 76
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 Iran University of Medical Sciences
Street address
Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-02-24, 1396/12/05
Ethics committee reference number
IR.IUMS.REC 1396.9311686011

Health conditions studied

1

Description of health condition studied
Fatigue
ICD-10 code
F48.0
ICD-10 code description
Fatigue Psychogenic (general)

Primary outcomes

1

Description
Fatigue
Timepoint
Before the intervention and one week after the end of the intervention
Method of measurement
Fatigue Severity Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Music group
Category
Prevention

2

Description
Intervention group: Pilates exercise
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Ziaei Ardakan Hospital
Full name of responsible person
Ameneh Jahanbani Ardakani
Street address
Yazd, Ardakan, Ziaei Ardakan Hospital
City
Ardakan
Province
Yazd
Postal code
8951633686
Phone
+98 35 3152 2010
Email
Jahanbaniardekani.a@tak.iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyyed Kazem Malakouti
Street address
Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86709
Email
adminsite@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Ameneh Jahanbani Ardakani
Position
MS.c student of nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St., Tehran
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
Jahanbaniardekani.a@tak.iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Daryadokht Masrur Rudsari
Position
faculty of Nursing and Midwifery, IRAN University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St., Tehran
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
masror.d@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ameneh Jahanbani Ardakani
Position
MS.C student of nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St., Tehran
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
Jahanbaniardekani.a@tak.iums.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
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