Determining the Effect of Midwifery-led childbearing counseling on fertility knowledge, desire and intention among New couple.
Design
The study will be conducted on 112 newly married couples who are randomly placed in two intervention and control groups. Block randomization method will be used for randomization using internet tools.
Settings and conduct
Sampling is done in two premarital counseling centers in Alborz province. Early sampling will be available at first. In this way, the researcher contacts the eligible people using the phone number listed in their file and after explaining about the objectives and method of conducting the research and the confidentiality of the information obtained, invites the eligible people to complete the questionnaires online. Eligible students are placed in a list with a row number, block randomization is used for random allocation .
Participants/Inclusion and exclusion criteria
Inclusion criteria: Iranian men and women able to speak Farsi; be literate in reading and writing; aged 18-39 for women, 18-49 for men, without previous marriage; cohabitation within one month. Exclusion criteria: the personnel of medical department; couples who have not lived together after one month for any reason; as well as chronic physical; severe mental illnesses.
Intervention groups
First, the participants will be placed in two intervention and control groups. The intervention will be carried out in 4 child-bearing counseling sessions (3 couples and private sessions in virtual space and 1 online Sky Room session in a group of 14 people, men and women separately. And the participants of the control group will only undergo routine pre-marriage counseling.
Main outcome variables
The knowledge and desire for fertility; the time of the intention of the first pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161230031662N12
Registration date:2022-10-05, 1401/07/13
Registration timing:prospective
Last update:2022-10-05, 1401/07/13
Update count:0
Registration date
2022-10-05, 1401/07/13
Registrant information
Name
Razieh Lotfi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3430 4433
Email address
raziehlotfi@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-29, 1401/08/07
Expected recruitment end date
2022-12-28, 1401/10/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of midwifery-Led childbearing counseling on fertility knowledge; desire and intention among New couple
Public title
The effect childbearing counseling By Midwife on fertility intention among New couple
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian men and women able to speak Farsi.
Be literate in reading and writing
Aged 18 to 39 for women and 18 to 49 for men
Without previous marriage
Cohabitation with one month
Exclusion criteria:
The personnel of the medical department
Couples who have not lived together after one month for any reason
Chronic physical and severe mental illnesses
Age
From 18 years old to 49 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method is used in the present study. This will be done using a random block internet tool via http://www.sealedenvelope.com/simple-randomiser/v1/lists. Block size is determined 4 and allocation was done upon arranges of codes in the blocks.
Randomization will concealed in sequentially numbered, sealed, opaque envelopes. After producing randomization sequence, 112 opaque envelopes will be provided and each randomization sequence is recorded on a card, then placed in the envelope in order. To keep concealment, envelopes are numbered too. The envelope is sealed and placed in a box in order. At the beginning of the registration of participants, according to the order of entry of eligible participants to study, one of the envelopes will be opened and the assigned group of the participant will be determined.
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 Alborz university of medical sciences
Street address
Alborz University of Medical Sciences, Shahrake Edari, North Taleghani, Azimieh, Karaj
City
Karaj
Province
Alborz
Postal code
3149779453
Approval date
2022-09-26, 1401/07/04
Ethics committee reference number
IR.ABZUMS.REC.1401.169
Health conditions studied
1
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Average fertility knowledge score in the Cardiff questionnaire
Timepoint
Before the start of the study and 4 weeks after the end of the intervention
Method of measurement
The Cardiff Psychometric Fertility Knowledge Questionnaire
2
Description
The mean fertility tendency score in the questionnaire of Naghibi et al
Timepoint
Before the start of the study and 4 weeks after the end of the intervention
Method of measurement
Fertility Desire Questionnaire, designed by Naghibi et al. (2019)
Secondary outcomes
1
Description
The average time of intention to have the first child, in a question designed by the researcher
Timepoint
Before the start of the study and 4 weeks after the end of the intervention
Method of measurement
With a question designed by the researcher, the period of time (months) when they decide to have their first child after marriage is determined.
Intervention groups
1
Description
Intervention group: All couples eligible to enter the study will complete the personal profile form, fertility and fertility knowledge if they agree to participate in the initial study. Both groups will intervene and control the center's routine counseling services. Then a 60-minute intervention session of childbearing counseling in the form of a speech and group discussion will be held online for groups of 14 people in the intervention group (women and men in the sessions they want to be). Except for one session in the Sky Room, the rest of the sessions will be conducted as a (private) couple counseling on the appropriate virtual messenger network. Virtualization by phone, SMS;Text file, audio, online meetings (Skyroom) will be designed and implemented through suitable platforms and messaging systems. The time of the meetings will be adjusted with the coordination of the participants so that the maximum participation is held with the least obstacles. A meeting may be held in the morning and the next meeting in the evening. The participant's phone, email address and phone number connected to the virtual network will be collected from him to enable the exchange of information, interaction (participants are asked to view and study the contents) to inform the researcher to record in a sheet), complete the questionnaires and send the contents as well as the necessary reminders. Educational and advisory content about fertility knowledge will be compiled by the research team based on the guidelines of the Ministry of Health and the reliable sources and sites. After the end of the intervention, both groups will complete the questionnaires online again after one month. After the end of the intervention and completion of the questionnaires, a session of sex education and parenting in the form of a podcast and text file will be held for the control group. Contents in the field of anatomy and physiology in brief, the rate of fertility and infertility, the risks of delay in fertility, the safe time to wait until childbearing, the effect of age on women's fertility, the definition of infertility and the factors affecting infertility, the benefits of childbearing and its impact on health. family), fertility time during the monthly cycle, the impact of various and important factors in pregnancy such as obesity and smoking, sexually transmitted infections and information on infertility treatments and costs, etc.
Category
Other
2
Description
Control group:56 number of control group will receive only routine counseling.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Rastravesh premarital counseling center
Full name of responsible person
Shamsolmolok Faramarzi
Street address
Blv south taleghane ;vahdat street
City
karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3270 0011
Email
khc@abzums.ac.ir
2
Recruitment center
Name of recruitment center
Shohadae Fardis permarital counseling center
Full name of responsible person
Shamsolmolok Faramarzi
Street address
west canal; fardis
City
karaj
Province
Alborz
Postal code
-3149779453
Phone
+98 26 3650 0950
Email
khcalborz@abzums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr.mohamad Noore Sepehr
Street address
Safareean st, 45 metree golshahr
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
Email
Dr.noorisepehr@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Shamsolmolok Faramarzi
Position
BCs in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Medicine, University of Medical Sciences Campus, University of Art, End of West Bou Ali Street, Nobovvat Square, Karaj
City
karaj
Province
Alborz
Postal code
3149779453
Phone
768534192698+
Email
Poonehrad73@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Razieh Lotfi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Medicine, University of Medical Sciences Campus, University of Art, End of West Bou Ali Street, Nobovvat Square, Karaj
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3441 5351
Email
Lotfi_razieh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Shamsolmolok Faramarzi
Position
BCs in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Medicine, University of Medical Sciences Campus, University of Art, End of West Bou Ali Street, Nobovvat Square, Karaj
City
karaj
Province
Alborz
Postal code
3149779453
Phone
768534192698+
Email
Poonehrad73@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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Total potential data can be shared after unidentifiable people.
When the data will become available and for how long
Date will be in access 6 months after publishing the results.
To whom data/document is available
only for researchers working in academic and scientific institution.
Under which criteria data/document could be used
scientific studies
From where data/document is obtainable
using Email address:poonehrad73@gmail.com
What processes are involved for a request to access data/document