Determine the Effect of Immunization Training on the Depression, Anxiety and Stress of Pregnant Mothers
Design
Non-randomized clinical trial, control group, parallel groups, non-blind, pre-test and post-test
Sampling using available sampling method
With 60 pregnant women
Settings and conduct
A sample of 60 pregnant women referred to the clinics in the city of Dare_shahr is selected by means of a mild to moderate scorecard. Sampling is done non-randomly. In the test group, the samples are divided into 5 groups of 6, and each group has six sessions of immunization training each week for two 90-minute sessions. One and two months later, both groups are re-examined with a questionnaire. The data collection method is a demographic questionnaire and DASS-21.
Participants/Inclusion and exclusion criteria
Inclination to participate in the study
gestational age from 16 to 24 weeks
lack of mental illness in the individual and the first-degree family
having a higher education level or higher
healthy fetus in ultra sonographi surveys
single-strike pregnancy, no complications Pregnancy
no chronic diseases
Outcome criteria
preterm delivery
anxiety disorder during the study (Death of loved ones, separation from a spouse ...)
failure to attend 20% of psycho-immunization sessions
Intervention groups
Pregnant Mothers
Main outcome variables
Improve mental status of mothers with mental disorders.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130211012440N6
Registration date:2018-11-09, 1397/08/18
Registration timing:prospective
Last update:2018-11-09, 1397/08/18
Update count:0
Registration date
2018-11-09, 1397/08/18
Registrant information
Name
Ziba Taghizade
Name of organization / entity
Tehran University of Medical Sciences school of nursing and midwifery
Country
Iran (Islamic Republic of)
Phone
+98 21 8824 4694
Email address
taghizad@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the Effect of Psychological Immunization Strategy on Depression Anxiety and Stress of Pregnant Mothers
Public title
The Effect of Psychological Immunization Strategy on Depression, Anxiety and Stress of Pregnant Mothers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women referred to health centers in the city of Darreh_shahr city who have criteria for entry into the study and have been selected randomly Criteria for entering the study: The desire to participate in the study Gestational age between 16 and 24 weeks, Having no mental illness in the first person and family, Have a guidance level or higher Healthy fetus in ultrasound examination, Single pregnancy pregnancy, no pregnancy complications, Lack of chronic diseases
Exclusion criteria:
Outcome criteria include preterm delivery, anxiety disorder during the study (Death of loved ones, separation from a spouse ...), failure to attend 20% of psycho-immunization sessions
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:
60
Randomization (investigator's opinion)
Not 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 Tehran Univercity of Medical science
Street address
Tehran Univercity of Science, keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2018-10-15, 1397/07/23
Ethics committee reference number
IR.TUMS.VCR.REC.1397.470
Health conditions studied
1
Description of health condition studied
Depression, anxiety, stress
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Depression
Timepoint
Before the Intervention and One and Two Months After the Intervention
Method of measurement
Dass_21 Questionnaire
2
Description
Anxiety
Timepoint
Before the Intervention and One and Two Months After the Intervention
Method of measurement
Dass_21 Questionnaire
3
Description
Stress
Timepoint
Before the Intervention and One and Two Months After the Intervention
Method of measurement
Dass_21 Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Pregnant Mothers
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Moayeri clinic
Full name of responsible person
Masoomeh Teymouri
Street address
Republican Street opposite Mellat Bank
City
Dare_shahr
Province
Ilam
Postal code
12345678
Phone
+98 84 3522 2424
Email
masiteymouri1369@gmail.com
2
Recruitment center
Name of recruitment center
Taleghani Clinic
Full name of responsible person
masoomeh Teymouri
Street address
Taleghani kooy
City
Dare_shahr
Province
Ilam
Postal code
123456789
Phone
+98 84 3522 2131
Email
masiteymouri1369@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Cheraghi
Street address
Vice Chancellor for Research,Tehran University of Medical Sciences. Ghods St. Keshavarz Bv.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 5565
Email
masiteymouri1369@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Masoomeh teymouri
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ghods Avenue, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 8893 3768
Email
masiteymouri1369@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ziba Taghizade
Position
Phd in Reproduction Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Ghods Avenue, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 8893 3768
Email
Zibataghizadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masoomeh Teymouri
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ghods Avenue, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 8893 3768
Email
masiteymouri1369@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available