This randomized clinical trial study was conducted on 50 pregnant women referring to Motazedi hospital in Kermanshah in 2015. The purpose of this study is evaluation of physiological childbirth education effectiveness on pregnant women’s stress and mental health. Inclusion criteria include: Gestational age at least 20 weeks; Not suffering from anxiety and depression; Lack of warning signs during pregnancy; Do not suffering from abnormal stress due to adverse events.and exclusion criteria include: Dissatisfaction from the continued cooperation with the research; being absent three session or more of classes; occurrence of any problems during the study (pre-eclampsia, placenta previa, preterm labor symptoms of multiple pregnancy, PROM, etc. ); Abnormalities and fetal death. The. subjects were randomly divided into intervention and control groups. In the first meeting, before the start of classes, the questionnaires were completed by samples. In intervention group samples took part in educational classes that were 8 sessions and each sessions lasted ninety minutes. But women in control group remained untrained. The instruments used in this study are: self-made questionnaire of demographic characteristic, stress anxiety depression scale (DASS-21), Goldenberg mental health questionnaire (GHQ-28) which held in pretest and posttest on experimental and control groups. Fetal heart rate and blood pressure were controlled before the start of each session.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016100427633N2
Registration date:2016-10-17, 1395/07/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-17, 1395/07/26
Registrant information
Name
Foruzan Sharifipour
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3828 2101
Email address
f.sharifi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University Kermanshah Branch
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of physiological childbirth education
on pregnant women's stress and their mental health
Public title
Effectiveness of physiological childbirth education
on pregnant women' s stress and their mental health
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:Lack of anxiety and depression; do not using psychotropic drugs before and during pregnancy; Lack of warning signs during pregnancy; Do not suffering from abnormal stress due to adverse events.
Exclusion criteria:Dissatisfaction from continued cooperation with the research; being absent three session or more of classes; occurrence of any problems during the study (pre-eclampsia, placenta previa, preterm labor symptoms of multiple pregnancy, PROM, etc. ); Abnormalities and fetal death.
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
Islamic Azad University of Imam Khomeini Complex
Street address
Ferdowsi Square,The end of town of experts
City
Kermanshah
Postal code
Approval date
2015-11-16, 1394/08/25
Ethics committee reference number
19220701941020
Health conditions studied
1
Description of health condition studied
stress and mental health
ICD-10 code
O99.3
ICD-10 code description
Mental disorders and diseases of the nervous system complicating pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Stress
Timepoint
Before the first training session and at the end of the eighth session (last session)
Method of measurement
Depression Anxiety Stress Scale questionnaire
2
Description
mental health
Timepoint
Before the first training session and at the end of the eighth session (last session)
Method of measurement
General Health Questionnaire
Secondary outcomes
1
Description
Fetal heart rate
Timepoint
Before the start of each session
Method of measurement
Hearing with Sonokids
2
Description
Blood pressure of mother
Timepoint
Before the start of each session
Method of measurement
Blood pressure measurement
Intervention groups
1
Description
Control group: lack of education
Category
Prevention
2
Description
Intervention group :physiological childbirth education,number of eight sessions, each session for 90 minutes.
Control group: lack of education
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Moatazedi hospital Kermanshah
Full name of responsible person
Shohreh Ayoubi
Street address
Moatazedi hospital Kermanshah, Ferdowsi Square
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University Kermanshah Branch
Full name of responsible person
Mokhtar Arefi
Street address
End of town of experts, Ferdowsi Square
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University Kermanshah Branch
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
Kermanshah Medical Sciences
Full name of responsible person
Shohreh Ayoubi
Position
MA in Midwifery
Other areas of specialty/work
Street address
Etesam health center, Seventeen of Shahrivar Square
City
Kermanshah
Postal code
Phone
+98 83 3839 1445
Fax
Email
Bahar.yz@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University Kermanshah Branch
Full name of responsible person
Nabi Bostan
Position
PHD in Psychology
Other areas of specialty/work
Street address
End of town of experts, Ferdowsi Square
City
Kermanshah
Postal code
Phone
+98 83 3724 3187
Fax
Email
Nabibostan@iauksh.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah Medical Sciences
Full name of responsible person
Frozan Sharifipour
Position
MSc in Midwifery
Other areas of specialty/work
Street address
unit of 12, Mahestan building, Alley 23, Kashani Street, Town of Elahiyeh
City
Kermanshah
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)