Protocol summary

Summary
This clinical trial study will be conducted to determine the effect of Pilates exercises on happiness and professional self concept in nurses of critical care and emergency units. 110 eligible nurses will be selected via convenience sampling and will be allocated into two intervention and control groups by using stratified random allocation. The intervention group will be trained for Pilates exercises under supervision of coach during a 3-hour workshop session. After ensuring proper performance of exercises, instructional video of Pilates exercises and educational posters will be provided for intervention group. The intervention group will run exercises three sessions per weeks for 8 weeks. Data will be gathered at baseline and 8 weeks after intervention in both intervention and control groups through Oxford Happiness Questionnaire and Nurses Professional Self Concept Questionnaire.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016022517237N7
Registration date: 2016-05-27, 1395/03/07
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-05-27, 1395/03/07
Registrant information
Name
Mahnaz Modanloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3245 6900
Email address
modanloo.mahnaz@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Golestan University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-10-21, 1395/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Pilates exercises on happiness and professional self concept of nurses in Critical Care and Emergency Units
Public title
The effect of Pilates exercises on happiness and professional self concept
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: A bachelor's degree or higher in nursing; working in the intensive care or emergency units; no history of life events and crisis such as accidents; relatives' death and divorce in the past six months; no history of regular professional sports; no prohibition for exercise; no history of heart diseases; respiratory failure; acute or chronic physical problems interfere to exercise. Exclusion criteria: Specific diseases or life-threatening conditions; inability to continue exercise; accidents or unforeseen events during the study; crisis such as divorce; death and loss of loved ones during the study; immigration; lack of exercise three times continuous or six sessions interrupted for any reason.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Golestan University of Medical Sciences
Street address
Deputy of Research and Technology, Golestan University of Medical Sciences, Hirkan Boulevard, Gorgan
City
Gorgan
Postal code
4934174515
Approval date
2016-04-10, 1395/01/22
Ethics committee reference number
ir.goums.rec.1395.5

Health conditions studied

1

Description of health condition studied
Physical activity
ICD-10 code
Z72.3
ICD-10 code description
Lack of physical exercise

Primary outcomes

1

Description
Happiness
Timepoint
Before intervention and after 8 weeks intervention
Method of measurement
Oxford Happiness Quassionnaire

Secondary outcomes

1

Description
Professional Self Concept
Timepoint
Before intervention and after 8 weeks intervention
Method of measurement
Nurses Professional Self Concept Questionnaire

Intervention groups

1

Description
The intervention group: During a three-hour workshop under the supervision of the coach, they will train how to do the Pilates exercises correctly. After ensuring proper performance of exercise, instructional videos of Pilates exercises and educational posters will be provided in the intervention group. The intervention group will run exercises three sessions per weeks for 8 weeks.
Category
Lifestyle

2

Description
Control group: In this group any intervention will be done and they carry out their daily routine works.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Payambar Azam Hospital
Full name of responsible person
Hossein Milani
Street address
Payambar Azam Hoapital, Beginning of the Incheboron Road, Gonbad Kavoos
City
Gonbad Kavoos

2

Recruitment center
Name of recruitment center
Shahid Motahari Hospital
Full name of responsible person
Dr. Arab
Street address
Shahid Motahari Hospital, Eastern Taleghani Street, Gonbad Kavoos
City
Gonbad Kavoos

3

Recruitment center
Name of recruitment center
Shohada Hospital
Full name of responsible person
Mohammad Hossein Rajabi
Street address
Shohada Hospital, Southern Imam Khomyni Street, Gonbad Kavoos
City
Gonbad Kavoos

4

Recruitment center
Name of recruitment center
Taleghani Children Hospital
Full name of responsible person
Dr. Milani
Street address
Taleghani Children Hospital, Taleghani street, Gonbad Kavoos
City
Gonbad Kavoos

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Golestan University of Medical Sciences
Full name of responsible person
Mohammad Hossein Taziki
Street address
Deputy of Research and Technology, Golestan University of Medical Sciences, Hirkan Boulevard, Gorgan
City
Gorgan
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 of Golestan 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
Golestan University of Medical Sciences
Full name of responsible person
Mahnaz Modanloo
Position
PhD
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Golestan University of Medical Sciences, Hirkan Bulvar
City
Gorgan
Postal code
4917136536
Phone
+98 17 3242 6900
Fax
+98 17 3242 5171
Email
modanloo1@yahoo.com: modanloo.mahnaz@goums.ac.ir
Web page address
www.goums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Gholamreza Mahmodi
Position
PhD
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Golestan University of Medical Sciences,Hirkan Bulvar, Gorgan
City
Gorgan
Postal code
4917136536
Phone
+98 17 3242 6900
Fax
+98 17 3242 5171
Email
mahmoodigh@yahoo.com
Web page address
http://goums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Halimohamad Parang
Position
MS Student of Critical Nursing Care
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Golestan University of Medical Sciences, Hirkan Bulvar, Gorgan
City
Gorgan
Postal code
4917136536
Phone
+98 17 3242 6900
Fax
+98 17 3242 5171
Email
halimohamad_parang59@yahoo.com
Web page address
http://goums.ac.ir

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
Loading...