Objectives: The aim of this study is to investigate the effect of education based on empowerment for nulliparous women on their empowerment and anxiety. Method: This is a randomized clinical trial. In this study, 70 nulliparous women who are in gestational ages of 20 - 24 weeks should be randomly placed in intervention and control groups with 35 people in each one. Inclusion criteria: having a low-risk pregnancy; the lack of use particular drug; no history of mental health problems or hospitalization related to mental health problems; having ages of 18 to 35; singleton pregnancy. Exclusion criteria: people who are treated for anxiety disorders; mothers who are involved by complication of pregnancy such as hypertension; toxemia of pregnancy; gestational diabetes; intrauterine fetal death and premature labor; during the study period, the mothers who do not attend at least two sessions of training sessions. Interventions: Pregnant women education based on empowerment which is an organized program will be done on 4 groups by 9 persons in each one. They will be attended in 4 training sessions during 4 weeks. Each session will be held in 90 minutes. In control group, prenatal care and education will be done individually. The main outcome variables: Pregnant women empowerment questionair and Spielberger State-Trait Anxiety Inventory will be completed before the intervention, immediately and 8 weeks after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201506042248N16
Registration date:2015-08-20, 1394/05/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-20, 1394/05/29
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
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2015-05-31, 1394/03/10
Expected recruitment end date
2015-11-01, 1394/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effectiveness of education based on empowerment for nulliparous women on their empowerment and anxiety
Public title
Effectiveness of the education based on empowerment for pregnant women on their empowerment and anxiety
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Iranian pregnant women; The first pregnancy; A low-risk pregnancy; A mild to moderate anxiety according to Spieberger Anxiety Scale; Gestational age 20 to 24 weeks; The lack of use particular drug; No history of mental health problems or hospitalization due to mental health problems; Age between 18 to 35 years; With literacy; Singleton pregnancy; No accidents in the last 3 months for the individual and first degree relatives. Exclusion criteria: The presence of known physical and mental illness such as diabetes; heart disease and psychosis including schizophrenia and paranoia that requires special medication and care; People who are treated for anxiety disorders; During the study; mothers who are involved by complication of pregnancy such as hypertension, toxemia of pregnancy; gestational diabetes; intrauterine fetal death; premature labor; Mothers who don’t desire to continue; Women who do not attend at least two sessions of training sessions.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, for sampling will be used the closed envelope.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hemmat Highway
City
Tehran
Postal code
Approval date
2015-05-26, 1394/03/05
Ethics committee reference number
IR.IUMS.REC.1394.26091
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Pregnant women empowerment
Timepoint
Before the intervention, immediately and 8 weeks after the intervention.
Method of measurement
Pregnant women empowerment questionair
Secondary outcomes
1
Description
Anxiety
Timepoint
Before the intervention, immediately and 8 weeks after the intervention.
Method of measurement
Spielberger State-Trait Anxiety Inventory (STAI)
Intervention groups
1
Description
Intervention group: After completing initial demographic questionnaires, pregnant women empowerment questionaires, Spielberger State-Trait Anxiety Inventory and having inclusion criteria, samples will be trained by instructor. Pregnant women education based on empowerment which is an organized program will be done on 4 groups by 9 persons in each one. They will be attended in 4 training sessions during 4 weeks. Each session will be held in 90 minutes. Pregnant women empowerment questionaires and Spielberger State-Trait Anxiety Inventory again will be completed immediately and 8 weeks after the intervention.
Category
Prevention
2
Description
Control group: There is not any intervention in control group, prenatal care and education to be done individually.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Training - Medical center Akbar Abadi
Full name of responsible person
Fereshteh Jahdi
Street address
Ferdose garden station, Molavi street, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Dr.Seyed Ali Javad Moosavi
Street address
Hemmat Highway
City
Tehran
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, Iran 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
School Nursing and Midwifery
Full name of responsible person
Zahra Koohsarian
Position
Master of midwifery
Other areas of specialty/work
Street address
School Nursing and Midwifery, Rashid Yasemi street, Vliasr street
City
Tehran
Postal code
Phone
+98 17 3577 9058
Fax
Email
zahrakooh1369@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Fereshteh Jahdi
Position
Master of midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Rashid Yasemi street, Vliasr street
City
Tehran
Postal code
Phone
+98 21 8888 2886
Fax
Email
Jahdi.Fr@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Fereshteh Jahdi
Position
Master of midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Rashid Yasemi street, Valiasr street
City
Tehran
Postal code
Phone
+98 21 8888 2886
Fax
Email
Jahdi.Fr@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)