Protocol summary

Study aim
The Effect of Pilates Sports Exercise on Reducing the Level of Stress, Anxiety, Depression and Lower Back Pain in Nurses working in Khorshid Hospital in Isfahan
Design
Clinical trials with an intervention and control group, one sucrose, randomized 70 people divided into two groups of 35 intervention and 35 controls
Settings and conduct
The Pilates Specialized Practitioner's Intervention Unit was conducted in the Occupational Therapy Hall of the Khorshid Hospital for 8 weeks, three times a week and at one-hour sessions. Pilates' selected exercises were conducted using classical and mattress techniques
Participants/Inclusion and exclusion criteria
Entry: Female nurses 20-50 years old - Having stress, anxiety and depression - Having back pain - Having a hospital stay for at least 3 months Exit: Unwillingness to co-operate after the start of the process of illness that causes a limitation in physical activity - Use of motor vehicles
Intervention groups
In the intervention group, Pilates specialized exercises in the occupational therapy hall of the Khorshid Hospital were performed for 8 weeks, three times a week, and one-hour sessions. The Pilates exercises were based on the classical method and on the mattress.the control group did not intervene
Main outcome variables
Main variables: stress, anxiety, depression, low back pain, Pilates

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190303042904N1
Registration date: 2019-05-21, 1398/02/31
Registration timing: retrospective

Last update: 2019-05-21, 1398/02/31
Update count: 0
Registration date
2019-05-21, 1398/02/31
Registrant information
Name
zahra Aَlipoor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3777 0970
Email address
zahra_aalipoor@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
2017-10-23, 1396/08/01
Actual recruitment end date
2017-12-21, 1396/09/30
Trial completion date
2017-12-21, 1396/09/30
Scientific title
effect of pilates exercises on reducing stress, anxiety, depression and back pain of nurses working in khorshid hospital in isfahan
Public title
the effect of pilates on stress, anxiety, depression and low back pain of nurses
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Female nurses aged 30-50 years. Participation in the Pilates Exercise Program for 8 weeks Having stress, anxiety and depression according to the questionnaire Having back pain Not having a hospital stay for at least 3 months. Non-use of psychiatric drugs. Not having any exercise program in everyday life
Exclusion criteria:
Female nurses aged 30-50 years. Participation in the Pilates Exercise Program for 8 weeks Having stress, anxiety and depression according to the questionnaire Having back pain Not having a hospital stay for at least 3 months. Non-use of psychiatric drugs. Do not have any exercise program in everyday life
Age
From 30 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 70
Actual sample size reached: 70
Randomization (investigator's opinion)
Randomized
Randomization description
The samples were randomly divided into two intervention and control groups by randomization method. We wrote the names of 70 participants and gave each person a code from 1 to 70 then, using a random number table with a computer software, 35 of them first came out of the table. The intervention group and 35 people whose code was taken out of the table later, the control group was selected
Blinding (investigator's opinion)
Double blinded
Blinding description
The 70 participants in the study did not know that they were either in the control group or the intervention group. The investigator also did not know that the 70 participants who entered the intervention group and who entered the control group (double blind)
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics Committee of the University of Social Welfare and Rehabilitation Sciences of Tehran
Street address
Evin Student Boulevard, Todiyar Street19
City
Tehran
Province
Tehran
Postal code
1985713871
Approval date
2017-08-23, 1396/06/01
Ethics committee reference number
IR.USWR.REC.1396.121

Health conditions studied

1

Description of health condition studied
Pilates
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Anxiety
Timepoint
The beginning of the study (before the intervention) and the end of 8 weeks after the exercises
Method of measurement
Anxiety using a standard DASS21 questionnaire

2

Description
stress
Timepoint
The beginning of the study (before the intervention) and the end of 8
Method of measurement
Stress using the standard DASS21 questionnaire

3

Description
Depression
Timepoint
The beginning of the study (before the intervention) and the end of 8
Method of measurement
Depression using the standard DASS21 questionnaire

4

Description
Back pain
Timepoint
The beginning of the study (before the intervention) and the end of 8
Method of measurement
Lower back pain using the Oswestry questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group trained in Pilates training for eight hours each week, three sessions and each session for one hour under the supervision of the trainer.
Category
Rehabilitation

2

Description
Control group: In this group, there will be no special action and will go to regular routine activities.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
بیمارستان
Full name of responsible person
زهرا عالی پور
Street address
Hasht – Behesht Ave., Ostandari St., Isfahan, Iran
City
Esfahan
Province
Isfehan
Postal code
8145831451
Phone
+98 31 3222 2127
Fax
+98 31 3222 2255
Email
nour@mui.ac.ir
Web page address
http://nour.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Dr. Mohammad Reza Khodaei
Street address
Tehran, Evin, Student Blvd, Childhood Death
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0083
Fax
+98 21 2218 0109
Email
Kh.ardakani@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation sciences
Proportion provided by this source
50
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
University of social welfare and rehabilitation sciences
Full name of responsible person
Zahra Aalipoor
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Esfahan, Vahid St., Alley 40, No. 29
City
Esfahan
Province
Isfehan
Postal code
8371181769
Phone
+98 31 3777 0970
Email
zahra_aalipoor@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Zahra Aalipoor
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Vahid St., Alley 40, No. 29
City
Esfahan
Province
Isfehan
Postal code
8371181769
Phone
+98 31 3777 0970
Email
zahra_aalipoor@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Zahra Aalioor
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Isfahan, Vahid St., Alley 40, No. 29
City
Esfahan
Province
Isfehan
Postal code
8371181769
Phone
+98 31 3777 0970
Email
zahra_aalipoor@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
A portion of the information, such as information on its main consequence, can be shared.
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Data will be available to researchers working in academia and academia
Under which criteria data/document could be used
Use and send email
From where data/document is obtainable
email address
What processes are involved for a request to access data/document
6 months after printing results
Comments
Loading...