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Effect of Multimedia Education on the Childbearing Intention in One-Child Women

Protocol summary

Study aim
Determining the impact of multimedia education on the willingness to have children in single-child women
Design
A clinical trial with a control group, with parallel groups, without blinding, randomized, on 100 women. A sealed envelope was used for randomization.
Settings and conduct
In order to carry out sampling, Maragheh city is divided into 4 regions: North, South, East and West. To prevent data contamination randomly and by lottery method, we assign two regions to the intervention group and two regions to the control group and randomly select one or more health centers or bases from each region. Among eligible women who refer to health centers and bases, sampling is done in a continuous manner and in proportion to the number of referrals.
Participants/Inclusion and exclusion criteria
1. Being Iranian 2. Being married 3. Having at least middle school education 4. Having only one child at least 2 years, 11 months and 29 days old 5. Age range from 15 to 45 years 6. Not wanting to have a second child
Intervention groups
For the Intervention Group, Multimedia Educational Content, Including Videos, Images, and Audio, Will Be Shown in Person for the Participants in the Form of 3, 20-minute Videos during 3 Weeks (once a week). And at the End of Each Session, Questions and Answers and Group Discussions Will Be Held for 40 Minutes to Interact With the Participants. The Control Group Will not Receive Any Training, But at the End of the Study, Like the Intervention Group, the Films Will Be Shown to Them.
Main outcome variables
Childbearing Intention

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230227057549N1
Registration date: 2023-04-16, 1402/01/27
Registration timing: prospective

Last update: 2023-04-16, 1402/01/27
Update count: 0
Registration date
2023-04-16, 1402/01/27
Registrant information
Name
Nasrin Aghazadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3741 4494
Email address
nasrinaghazade7@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-30, 1402/02/10
Expected recruitment end date
2023-11-01, 1402/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Multimedia Education on the Childbearing Intention in One-Child Women
Public title
Effect of Multimedia Education on the Childbearing Intention in One-Child Women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being Iranian Being Married Having at Least a Middle School Education Having Only One Child at Least 2 Years, 11 Months and 29 Days Old Age Range from 15 to 45 Years Reluctance to Have a Second Child
Exclusion criteria:
Suffering from Physical and Mental Illness That Hinders learning The Existence of Known Fertility Problems in the Husband or Wife Contraindications for Pregnancy Reported by the Woman and the Health center file Attending Similar Training Programs
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
N/A
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 Iran University of Medical Sciences
Street address
Iran University of Medical Sciences Shahid Hemmat Highway,Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2023-02-06, 1401/11/17
Ethics committee reference number
IR.IUMS.REC.1401.916

Health conditions studied

1

Description of health condition studied
Childbearing
ICD-10 code
O00-O99
ICD-10 code description
Childbearing, pregnancy

Primary outcomes

1

Description
The score of desire to have children in the Miller questionnaire
Timepoint
The beginning of the study (before the start of the intervention), the end of the intervention and 6 weeks after the end of the intervention
Method of measurement
Miller's Childbearing Desire Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
The multimedia educational content includes videos, images, and audio, which will be prepared in the form of 3 20-minute videos, and at the end of each session, questions and answers and group discussions will be held for 40 minutes to interact with the participants. The content of the sessions, in order from the first to the third session, includes: the first session: information about demographic changes in Iran and the world and new population policies, the second session: the importance and benefits of having children, the consequences of having a single child from the perspective of the family and society, answers to common questions about Having a child, the third session: the harms of having a single child with the approach of psychology and educational sciences, the problems and obstacles related to having a healthy lifestyle before pregnancy will be presented to the participants in person for 3 weeks (once a week).
Category
Lifestyle

2

Description
Control group: There is no intervention for the control group.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Maragheh University of medical science
Full name of responsible person
Nasrin Aghazadeh
Street address
Maragheh city
City
Maragheh
Province
East Azarbaijan
Postal code
5518854171
Phone
+98 41 3725 6920
Email
nasrinaghazade7@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hossein Kiwani
Street address
Shahid Hemet highway, Region 2, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Fax
+98 21 8862 2703
Email
research-m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Leila Amini
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing & Midwifery Rashid Yasemi St. Valiasr St. Tehran
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
Amini.l@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila Amini
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing & Midwifery Rashid Yasemi St. Valiasr St. Tehran
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
Amini.l@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila Amini
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing & Midwifery Rashid Yasemi St. Valiasr St. Tehran
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
Amini.l@iums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
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
Not applicable
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