Determining the effect of life skills training on the attitude of fertility and childbearing in married women
Design
The study will be a randomized controlled clinical trial. People who meet the conditions to enter the study will be selected as available and will be included in the study by signing a written consent form. Individual-social questionnaires, Persian version of the Fertility Attitude Scale Childbearing will be available to sample people. The intervention will be done face-to-face and virtual in social groups using mobile phones
Settings and conduct
All married women referring to comprehensive health centers covered by Iran University of Medical Sciences will complete the questionnaires after obtaining informed consent from both control and intervention groups. The evaluation of the results will be done immediately and 2 months after the intervention of the last session by two groups
Participants/Inclusion and exclusion criteria
Eligibility criteria: Being married, Childless and single child, Being of reproductive age ,First marriage, Consent to participate in the study, Literacy for reading and writing, Being Iranian and living in Tehran, Ability to use smartphones
.Exclusion criteria: Pregnancy, Breastfeeding, Menopause, sterility, Mental and physical illness that affects fertility, Having a history of teaching life skills, Foreign clients
Intervention groups
Life skills training sessions based on the training content that has been prepared in advance
Main outcome variables
Attitude of fertility and childbearing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240225061104N1
Registration date:2024-08-07, 1403/05/17
Registration timing:registered_while_recruiting
Last update:2024-08-07, 1403/05/17
Update count:0
Registration date
2024-08-07, 1403/05/17
Registrant information
Name
zahra ferdowsi zadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5592 9651
Email address
ferdowsizadehz@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2025-01-19, 1403/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of life skills training on fertility and childbearing attitudes of married women
Public title
The effect of life skills training on fertility and childbearing attitudes of married women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
married women do not intend to pregnant
reproductive age between 15 to 49
single or childless
first marriage
being literate in reading and writing
ability to use smart phone
a resident of tehran
consent to participate in the study
Exclusion criteria:
pregnancy
breast feeding
Menopause
sterility
Mental and physical illness that affects fertility
Having a history of teaching life skills
Foreign clients
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The sample people will be randomly allocated into two control and intervention groups using the random allocation method. This means that in each center, the names B and A will be considered for the two groups. Letters will be written in the same number of participants on folded pieces of paper, and through lottery, people will choose the papers without replacing them, then the created sequence will be recorded. In this way, the sample people will be divided into two intervention groups (the group that receives training) and the control group (the group that does not receive training).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
bahonar street
City
qazvin
Province
Qazvin
Postal code
3419759811
Approval date
2024-07-02, 1403/04/12
Ethics committee reference number
IR.QUMS.REC.1403.138
Health conditions studied
1
Description of health condition studied
Examining fertility and child bearing attitude of married women without children or single children
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Fertility and childbearing attitude
Timepoint
Before the intervention, immediately after the intervention, two months after the intervention
Method of measurement
Fertility and childbearing attitudes survey questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Intervention group: life skills training is carried out in 4 sessions (each session, for 30-60 minutes) in the intervention group and in person-virtual and group.
Category
N/A
2
Description
Control group:no intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
مراکز سلامت تحت پوشش دانشگاه علوم پزشکی ایران
Full name of responsible person
زهرا فردوسی زاده نایینی
Street address
اتوبان شهید همت
City
تهران
Province
Tehran
Postal code
1871963373
Phone
+98 21 5592 9651
Email
ferdowsizadehz@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
seyed mehdi mirhashemi
Street address
Ba honar
City
Qazvin
Province
Qazvin
Postal code
۵۹۸۱۱۳۴۱۹۷
Phone
+98 28 3333 6001
Email
papoy6olfati@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
1
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
zahra ferdowsi zadeh
Position
midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ba honar
City
Qazvin
Province
Qazvin
Postal code
۳۴۱۹۷۵۹۸۱۱
Phone
+98 28 3333 6001
Email
ferdowsizadehz@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
zahra ferdowsi zadeh
Position
midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ba honar
City
Qazvin
Province
Tehran
Postal code
۳۴۱۹۷۵۹۸۱۱
Phone
+98 28 3333 6001
Email
ferdowsizadehz@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
zahra ferdowsi zadeh
Position
midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ba honar
City
Qazvin
Province
Qazvin
Postal code
۳۴۱۹۷۵۹۸۱۱
Phone
+98 28 3333 6001
Email
ferdowsizadehz@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
There is a program for publication. After the article is printed, if a request is received, the data file will be shared
When the data will become available and for how long
There is a program for publication. After the article is printed, if a request is received, the data file will be shared
To whom data/document is available
There is a program for publication. After the article is printed, if a request is received, the data file will be shared
Under which criteria data/document could be used
There is a program for publication. After the article is printed, if a request is received, the data file will be shared
From where data/document is obtainable
There is a program for publication. After the article is printed, if a request is received, the data file will be shared
What processes are involved for a request to access data/document
There is a program for publication. After the article is printed, if a request is received, the data file will be shared