A randomized controlled trial, double blind design will be carried to conduct the study. The population included 60 pregnant women. Subjects will be referred to Akbar Abadi’s hospital and selected with Random allocation method. The data collection instrument will be demographic questionnaire, VAS (Visual Analogue Scale) and Beck Inventory scale. Women will be randomized into either a control or experimental group. Subjects in the experimental group will be started yoga programme at the 26 week of gestation. The women will be received a booklet and tape cassette (CD), that will explains the principles and benefits of each yoga practice. All will be asked to practice at home three times a week by the end of 37 weeks. Maternal anxiety will be evaluated in 26th and the end of 37th week of gestation. Maternal satisfaction of yoga programme will evaluated by self-made questionnaire in the end of 37 week of gestation. The first measurement of pain intensity in labour will taken when cervical dilatation will be 3-4 cm. the second and the third measurement will be evaluated when 2 hours after the first assessment and 2 hours after the second assessment cervical dilatation, respectively. Length of labor will be recorded by using the standard clock. Apgar scores and newborn’s weight will be recorded in demographic questionnaire. Subjects in the control group will be received routine nursing care from hospital staff nursing, yoga practice will be not provided to the control group. All the variables will be assessed in the control group
General information
Acronym
yoga and pregnancy
IRCT registration information
IRCT registration number:IRCT201110052248N7
Registration date:2013-01-25, 1391/11/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-01-25, 1391/11/06
Registrant information
Name
Fereshteh Jahdi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00982188773073,00982182471404
Email address
f.jahdi@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Tehran University of Medical Sciences
Expected recruitment start date
2012-01-21, 1390/11/01
Expected recruitment end date
2012-06-21, 1391/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of a prenatal yoga programme in the second and third trimester of pregnancy on the Anxiety and pregnancy outcomes at primiparouse women
Public title
The Effect of a prenatal yoga programme in the second and third trimester of pregnancy on the Anxiety and pregnancy outcomes at primiparouse women
Purpose
Prevention
Inclusion/Exclusion criteria
Not having recognized physically diseases such as heart disease, respiratory, kidney and maternal mental illness -There are not complications pregnancy such as placenta previa,Placental abruption, increased or decreased blood pressure,Increased and decreased abnormal volume of amniotic fluid , Display abnormal fetuses confirmed by sonography-Elimination of obese women and skinny BMI according to (less than19/8 and more than 26) - non-elective cesarean section - Not having of experience of doing yoga- there are no obvious abnormalities or fetal growth retardation in the fetus confirmed by ultrasound
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran - Keshavarz Blvd - Central Headquarters Building - Tehran University of Medical Sciences
City
tehran
Postal code
Approval date
2011-04-17, 1390/01/28
Ethics committee reference number
12962
Health conditions studied
1
Description of health condition studied
Pregnancy
ICD-10 code
O00-O99
ICD-10 code description
pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Level of anxiety
Timepoint
Week 26, end of 37 weeks
Method of measurement
Beck Anxiety Questionnaire
2
Description
Pain intensity
Timepoint
Labor time
Method of measurement
Visual pain ruler
Secondary outcomes
1
Description
newborn’s weight
Timepoint
Time of Birth
Method of measurement
Gram
2
Description
Delivery type
Timepoint
Delivery time
Method of measurement
Natural - Cesarean section - Delivery of Tools
3
Description
The first and fifth minute Apgar score
Timepoint
After delivery
Method of measurement
Number
Intervention groups
1
Description
Subjects in the control group will be received routine nursing care from hospital staff nursing, yoga practice will be not provided to the control group. All the variables will be assessed in the control group.
Category
Other
2
Description
Subjects in the experimental group will be started yoga programme at the 26 week of gestation. The women will be received a booklet (pamphlets) and tape cassette (CD), for self study, that will explains the principles and benefits of each yoga practice. All will be asked to practice at home three times a week by the end of 37 weeks. Maternal anxiety will be evaluated in 26th and the end of 37th week of gestation. Maternal satisfaction of yoga programme will evaluated by self-made questionnaire in the end of 37 week of gestation. The first measurement of pain intensity in labour will taken when cervical dilatation will be 3-4 cm. the second and the third measurement will be evaluated when 2 hours after the first assessment and 2 hours after the second assessment cervical dilatation, respectively. Length of labor will be recorded by using the standard clock. Apgar scores and newborn’s weight will be recorded in demographic questionnaire.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
General Womens hospital
Full name of responsible person
freshteh jahdi
Street address
Tehran- ST hafte tiri - Avenue vila
City
tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Tehran University of Medical Sciences
Full name of responsible person
Dr. Fotuhi
Street address
Keshavarz Blvd - Qods Ave - University of Central Organization - six Category
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Tehran 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
Nursing And Midwifery Faculty - University of Medical Sciences Tehran
Full name of responsible person
fereshteh jahdi
Position
The Faculty - Head of Group
Other areas of specialty/work
Street address
Tehran - Tohid Square - Nusrat East -Nursing And Midwifery Faculty - University of Medical Sciences Tehran
City
tehran
Postal code
Phone
+216 6921185
Fax
+98 66904252
Email
jahdi_fr@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing And Midwifery Faculty - University of Medical Sciences Tehran
Full name of responsible person
fereshteh jahdi
Position
MSc in Midwifery
Other areas of specialty/work
Street address
Tehran - Tohid Square - Nusrat East - Nursing And Midwifery Faculty - University of Medical Sciences Tehran
City
tehran
Postal code
Phone
+216 6937120
Fax
+98 66904252
Email
jahdi_fr@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)