Determination of affecting of Pilates program exercise on Matenal stress and anxiety in primigravida women.
Design
This study is randomiseg clinic trial with designing pre-post test .
Settings and conduct
This study carry out in the area Ahvaz west Health center-2 and 3.The sample includ a total of 100 primigravida womem, who through block randomization split into an intervention group and a control group.All the women have voluntery access from the prenatal clinic to participante in the study,and are informed of the procedures,risk and benefits of study.They sign a written consent form at the biginning of the study.
Participants/Inclusion and exclusion criteria
primigravida women (18-35 years old )and(BMI;20-30)that no have medical desease and obestetric complications.
Intervention groups
pregnant women recive an eight-week programme of physical exercise using the pilates method,with three sessions per week lasting 40-45 minutes.
Effect of pilates exercise program on stress and anxiety in primigravida women.
Public title
Effect of pilates exercise program on stress and anxiety in primigravida women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian nation
Gestational age 26-24 week
BMI:30-20 kg/m2
primigravida
mono fetus pregnancy
Able to study and writting
Min score of anxiety;150(wendenberg questionnaire)
Min score of stress ;21.8(cohen questionnaire)
Exclusion criteria:
History of cardiac-polmonary desease.
Obstetric complicatios:placenta previa,Incompetence cervix
Treatened abortion,bleeding,PROM.
History of depression
participate other exercise program or physiologic delivery class.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the block randomization method is used for randomization.In this way, blocks create with pair numbers(4 or 6) and half the people in each block are randomly assigned to one group and half to another.Then, the block is selected to reach the required sample.For example, if we want to put 100 peoples in two groups of A and B,we must first find all four states in which half of the people to group A and other group B, are assigned to specify.Then go to each of these modes, we attribute 1 to 6.Next we have to make 25
four blocks randomly and write its combinations together.To do this, we have to sample this community 25 times up to the required sample size(50 peoples group A , 50 peoples group B).
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 Ahvaz Jundishapoor University of Medical sciences.
Street address
Medical Bolv, Khozestan provice, Ahvaz.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2019-08-19, 1398/05/28
Ethics committee reference number
IR.AJUMS.REC.1398.395
2
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapoor University of Medical sciences.
Street address
Medical Bolv, Khozestan provice, Ahvaz.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2019-08-19, 1398/05/28
Ethics committee reference number
IR.AJUMS.REC.1398.395
Health conditions studied
1
Description of health condition studied
Maternal stress and anxiety
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Maternal anxiety in primigravida women.
Timepoint
0 ,8 week
Method of measurement
vandenberg questionnaire
Secondary outcomes
1
Description
Maternal stress in primigravida women.
Timepoint
0,8 week
Method of measurement
cohen questionnaire
Intervention groups
1
Description
Intervention group: Intervention is carried out through an eight-week programme of physical exercise using the pilates method, three time per week lasting 40-45 minutes.This program is supervised by professional in this area and researcher in Health center weekly.The pilates programme sessions are conducted two time per week in home with using habdbook and DVD and racord by exprimental group.control group resive only routine prenatal care.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz West Health Center
Full name of responsible person
mehrdad sharifi
Street address
Between 15 and 16 street, Kian Abad Bolv,Ahvaz.
City
Ahvaz
Province
Khouzestan
Postal code
6155745477
Phone
+98 61 3391 4234
Fax
Email
info@ajums.ac.ir
Web page address
https://www.hn-wah.ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Afshin zarghi
Street address
school of Nursing and Midwifery of Jundishapur ,golestan Bolv, Ahvaz.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794a
Phone
+98 61 3373 8331
Fax
+98 61 3373 8333
Email
fnursing-ahvaz@ajums.ac.ir
Web page address
https://www.ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Parvaneh mousavi
Position
Educator
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
school of Nursing and Midwifery of Jundishapur, Golestan Bolv,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8331
Fax
+98 61 3373 8333
Email
mousavi-p@ajums.ac.ir
Web page address
https://www.fnursing.ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Parvaneh
Position
Educator
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
school of Nursing and Midwifery of Jundishapur,.Golestan Bolv,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
098 61 33738331
Fax
+98 61 3373 8333
Email
mousavi-p@ajums.ac.ir
Web page address
https://www.fnursing.ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
parvaneh mousavi
Position
Educator
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery of Jundishapur, Golestan Bolv,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8331
Fax
+98 61 3373 8333
Email
mousavi-p@ajums.ac.ir
Web page address
https://fnursing.ajums.ac.ir
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
Information related to resultes will share after unrecognising of subgets.
When the data will become available and for how long
6 month after publication of results
To whom data/document is available
Researchers working in medical Institues.
Under which criteria data/document could be used
Only researchers can analyzed the results.
From where data/document is obtainable
Email of responsible of study.
What processes are involved for a request to access data/document