This study has been designed to evaluate the effect of childbirth preparation classes emphasizing on physical exercise on the positive emotion and vitality of nulliparous pregnant women in 2015. Sampling is done by random sampling method. The study population consists of all nulliparous pregnant women attending prenatal clinics of Health Network at Famenin city. Inclusion criteria: 20-28 weeks gestational age; absence of anxiety and depression; avoiding the use of psychotropic drugs before pregnancy and during the current pregnancy, according to patient records in Health Center and the doctor's visits; normal and planned pregnancy without obstetric and medical complications. Exclusion criterion: twice or more absences in classes; the incidence of horrible life events, such as death of a spouse, divorce, etc.; medical and obstetric problems during the study; diagnosis of fetal malformation or death during the study. A sample of 50 women in the test group and 50 women in the control group are determined. In the test group, 50 people are selected by draw method and using the numbers of their records. Then among nulliparous pregnant women eligible for inclusion in the study who wish to attend classes in preparation for childbirth, 50 women selected by the same method and placed in the control group. In the test group, antenatal educations are done with special emphasis on physical exercises and relaxation, and the control group members receive usual clinic cares. The main variable in this project is the positive emotion and vitality.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015081623640N1
Registration date:2015-11-10, 1394/08/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-10, 1394/08/19
Registrant information
Name
Farzaneh Soltani
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 813220683
Email address
soltani@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Research Technolog, Hamedan University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-01-21, 1394/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of physical exercise on positive emotion and vitality of primigravid women
Public title
The effect of exercise on the vitality and positive emotion primigravid
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria to study:" gestational age of 20 weeks or more"؛" lack of anxiety and depression and lack of psychoactive medications before pregnancy and during pregnancy, according to doctor's comments and patient records in health center"؛" normal pregnancy without midwifery and medical side effects" Exclusion criterion:" more than two times of absence in classes"؛" the incidence of unpleasant life events"؛" such as death of a spouse, divorce"؛" medical and midwifery problems during the study "؛" detection of abnormalities or fetal death during the study.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
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 the University of Medical Sciences
Street address
Vice Chancellor of Research and Technology,Hamadan Univercity of Medical Siences,Shahid Fahmideh Avenue,Hamadan
City
hamadan
Postal code
6516645977
Approval date
2015-08-15, 1394/05/24
Ethics committee reference number
IR.UMSHA.REC.1394.256
Health conditions studied
1
Description of health condition studied
The effects of physical exercise on positive emotion and vitality of primigravid women
ICD-10 code
O94-O99
ICD-10 code description
Other obstetric conditions, not elsewhere classified
Primary outcomes
1
Description
Positive emotion
Timepoint
4 month
Method of measurement
Positive and Negative Affect Scale Panas
2
Description
vitality
Timepoint
4month
Method of measurement
Deci and Ryan vitality questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:The classes will be held every two weeks for an hour and a half, for 8 times, with a maximum of 10 pregnant women, and includes 5 minutes of greetings, 30 minutes of training, 10 minutes for questions and answers, 30 minutes of physical exercise, and 10-15 minutes of relaxation, and the last 10-15 minutes is dedicated to video playback and questions and answers. Mothers wear comfortable clothes at the time of exercises and do their workouts with the trainer for 30 minutes at a suitable place. Mothers are recommended to do exercises and relaxation at home every day, and every two days, mother will receive a phone call, and they will be encouraged to exercise at home. After 36 weeks of the end of the classes, the questionnaires will be completed again by test group. Then the data analysis will be conducted and the results of the impacts of training and exercise classes on positive affection and vitality before and after the intervention
Category
Lifestyle
2
Description
The control group: receives the routine cares of prenatal clinic. and In order to regard the ethical principles in the control group, after the completion of training, they will be given educational pamphlet After 36 weeks of the end of the classes, the questionnaires will be completed again by control group. Then the data analysis will be conducted and the results of the impacts of training and exercise classes on positive affection and vitality before and after the intervention
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Network famenin
Full name of responsible person
Samereh Ghelichkhani- Student Of Master of Midwifery Counseling
Street address
City famenin
City
famenin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Research Technolog, Hamedan University of Medical Sciences
Full name of responsible person
Doctor Bashirian Saeed
Street address
Hvice Chancellor of Research Technology, Hamedan University of Medical Siences,Shahid Fahmideh Avenue,Hamedan
City
hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Research Technolog, Hamedan 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
Hamedan Univercity of Medical Sience
Full name of responsible person
dr farzaneh soltani
Position
PhD in Reproductive Health
Other areas of specialty/work
Street address
school of Nursung dnd Midwifery,Hamedan Universty of Medical Sience,Shahid Fahmideh Ave,Hamedan
City
hamedan
Postal code
6516845977
Phone
+98 81 3838 0150
Fax
+98 81 3838 0447
Email
sa.ghelichkhani@gmail.com
Web page address
farzanehsoltani2008@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Medical Sciences
Full name of responsible person
dr farzaneh soltani
Position
PhD in Reproductive Health
Other areas of specialty/work
Street address
school of Nursung dnd Midwifery,Hamedan Universty of Medical Sience,Shahid Fahmideh Ave,Hamedan
City
hamadan
Postal code
6516645977
Phone
+98 81 3838 0150
Fax
+98 81 3838 0447
Email
farzanehsoltani2008@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
University of Medical Sciences
Full name of responsible person
samereh ghelichkhani
Position
Bachelor Of Midwifery/ Student Of Master of Midwifery Counseling
Other areas of specialty/work
Street address
School of Nursing And Middwifery ,Hamedan University of Medical Sciences,Fahmideh Ave
City
hamedan
Postal code
6516645977
Phone
+98 81 3838 0150
Fax
+98 81 3838 0447
Email
sa.ghelichkhani@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)