Protocol summary

Study aim
Explain reproductive behavior and then design and determine the effect of educational program on the intention of reproductive behavior of married women of reproductive age in Rasht
Design
: Mixed Method Study. quantitative and qualitative stage, with control group, parallel groups, randomized, 114 samples, Random allocation software
Settings and conduct
The combined study will be done in two quantitative and qualitative stages. The study units are married women of reproductive age who refer to comprehensive health centers in the city.
Participants/Inclusion and exclusion criteria
Minimum age 15 and maximum age 49 years Covered by comprehensive health centers in Rasht Absence of infertility problems with female and male factors Willingness to participate in the study Two years have passed since the marriage
Intervention groups
Qualitative stage: In the qualitative stage, the inductive-deductive approach will be used. Needs assessment is performed using semi-structured and in-depth interviews with married women of childbearing age. Quantitative study (implementation): This part of the study is a quasi-experimental study (educational intervention) with a control group. The research units are randomly assigned to two groups of test and control. Before the training program, the questionnaire of reproductive behavior in the two groups of intervention and control is completed by the research units and then the educational software will be installed on the mobile phones of the intervention group and these people will receive training. The control group did not receive any intervention from the researcher.
Main outcome variables
intention reproductive behavior

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180707040364N2
Registration date: 2022-01-12, 1400/10/22
Registration timing: prospective

Last update: 2022-01-12, 1400/10/22
Update count: 0
Registration date
2022-01-12, 1400/10/22
Registrant information
Name
Parisa Farzi karamolahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3355 5058
Email address
parisa.farzi92@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-03, 1400/11/14
Expected recruitment end date
2022-07-05, 1401/04/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Explanation, design and evaluation of intention reproductive behavior education program of married women of reproductive age: Mixed Method Study
Public title
Explanation, design and evaluation of intention reproductive behavior education program of married women of reproductive age: Mixed Method Study
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Minimum age 15 and maximum age 49 years Covered by comprehensive health centers in Rasht Absence of infertility problems with female and male factors Willingness to participate in the study Two years have passed since the marriage
Exclusion criteria:
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: 114
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use the restricted randomization method of block randomization. Blocking is usually used to balance the number of samples assigned to each of the study groups. This feature helps researchers to equate the number of samples assigned to each of the study groups in cases where intermediate analyzes are required during the sampling process. Random allocation software is also used for randomization tools. In addition to simple randomization, random sequence generation software is able to generate random sequences by block generation method. For concealment, we use allocation concealment, which is the method used to execute a random sequence on the study participants, so that the assigned group is not known before the individual is assigned. Using opaque envelopes sealed with random sequences (Sequentially numbered, sealed, opaque envelopes) in which in this method each of the random sequences created is recorded on a card and the cards in the envelopes to They are placed in order.In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed.
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
Research Ethics Committees og Guilan Univercity of Medical Sciences
Street address
Rasht - Namjoo St. - Shahid Siadati St. - in front of Shahrivar Hospital - Vice Chancellor for Research and Technology
City
Rasht
Province
Guilan
Postal code
4146939114
Approval date
2021-11-23, 1400/09/02
Ethics committee reference number
IR.GUMS.REC.1400.418

Health conditions studied

1

Description of health condition studied
intention reproductive behavior education program of married women of reproductive age
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
intention reproductive behavior
Timepoint
Before and after the intervention
Method of measurement
Reproductive Behavior Intention Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
In the intervention group: educational content based on the intention of women's reproductive behavior before the training program, a questionnaire in both intervention and control groups will be completed by the research units and then the educational software will be installed on the mobile phones of the intervention group. During the installation, the participants will be taught how to use and work with the software, and 1 week after installing the program on the mobile phone of the intervention group, they will be contacted and answered any questions and problems regarding the use of the software. will be given. The duration of training is 8 weeks.
Category
Other

2

Description
Control group: Control group: The control group is not subject to any intervention by mobile phone software and is not aware of the implementation of the training program in the control group.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Comprehensive health centers
Full name of responsible person
Zahra Bostani Khalesi
Street address
Comprehensive Health Center, Pasteur Three Ways, Rasht
City
Rasht
Province
Guilan
Postal code
4471683835
Phone
+98 13 3382 0051
Email
z_bostani@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
mohammad Reza Naghipoor
Street address
In front of 17 Shahrivar Hospital, Shahid Siadati St.Namjoo St.
City
Rasht
Province
Guilan
Postal code
4146939114
Phone
+98 13 3333 6394
Email
z_bostani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Zahra Bostani Khalesi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shahid Beheshti School of Nursing and Midwifery, Student Park, Ice Square, Rasht
City
Rasht
Province
Guilan
Postal code
4146939841
Phone
+98 13 3355 5056
Email
z_bostani@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Zahra Bostani Khalesi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shahid Beheshti School of Nursing and Midwifery, Student Park, Ice Square, Rasht
City
Rasht
Province
Guilan
Postal code
4146939841
Phone
+98 13 3355 5056
Email
z_bostani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Zahra Bostani Khalesi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shahid Beheshti School of Nursing and Midwifery, Student Park, Ice Square, Rasht
City
Rasht
Province
Guilan
Postal code
4146939841
Phone
+98 13 3355 5056
Email
z_bostani@yahoo.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
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
Main and general data
When the data will become available and for how long
One year
To whom data/document is available
Faculty members of Shahid Beheshti School of Midwifery and Nursing, Rasht
Under which criteria data/document could be used
In order to check the accuracy of the data and with a written request in hand And approved by the Vice Chancellor for Research, Shahid School of Nursing and Midwifery Beheshti Rasht
From where data/document is obtainable
Library of Shahid Beheshti School of Midwifery and Nursing and also Written request from the project manager
What processes are involved for a request to access data/document
Permission from the librarian of Shahid Beheshti School of Midwifery and Nursing in Rasht Written form and contact with the project manager and make a moral agreement
Comments
Loading...