The Effect of Midwife-led Childbearing Counseling compared to routine care on Fertility Motivation and Empowerment of Women Referring to Health Centers
Determining the Effectiveness of Midwife-led Childbearing Counseling on Fertility Motivation and Empowerment of Women Referring to Selected Health Centers of Kashan City
Design
A randomized controlled clinical trial, with an intervention and a control group (parallel groups) on 130 people. Blinding will not be done in this study. The samples are selected as available and then the people are randomly assigned to two control and intervention groups using blocks of size 4. Random blocks will be generated through the site (www.sealedenvelope.com). For concealment, the randomized sequences are placed in sealed envelopes and numbered sequentially.
Settings and conduct
Four centers out of 14 urban health centers of Kashan city centers (with the most referrals) will form the research environment. All married women referring to urban health centers of Kashan city will form the research population. Blinding will not be done in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Iranian Muslim Couple;
Able to Speak Persian Language;
Having Minimum Reading and Writing Literacy;
Without Previous Marriage of Each Couple;
Having a Child at Least Two Years Old. Non-inclusion criteria:
Addiction in Each of the Couples;
Severe Chronic Physical and Mental Diseases in Each of the Couples;
Secondary Infertility Diagnosed in Each of the Couples;
Experience of Extreme Stress in Each of the Couples (During the Last Six Months)
Intervention groups
Intervention Group: Including 65 Qualified Women Who Will Receive 4 Face-to-Face Counseling Sessions in 60 Minutes/ One Session Every Week, in Groups of 15-20 People, by a Trained Midwife in addition of Routine Cares.
Control Group: Including 65 Qualified Women Who Will Only Receive Routine Cares.
Main outcome variables
Women's Empowerment;
Women's Fertility Motivation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230706058685N1
Registration date:2023-08-08, 1402/05/17
Registration timing:prospective
Last update:2023-08-08, 1402/05/17
Update count:0
Registration date
2023-08-08, 1402/05/17
Registrant information
Name
zahra mehdizadeh
Name of organization / entity
Alborz university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 26 3419 7000
Email address
zahramehdizadeh_t@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-21, 1402/05/30
Expected recruitment end date
2023-11-21, 1402/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Midwife-led Childbearing Counseling compared to routine care on Fertility Motivation and Empowerment of Women Referring to Health Centers
Public title
The Effect of midwife-led Childbearing Counseling on Fertility Motivation and Empowerment of Women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian Muslim Couple
Able to Speak Persian Language
Having Minimum Reading and Writing Literacy
Without Previous Marriage of Each Couple
Having a Child at Least Two Years Old
Exclusion criteria:
Addiction in Each of the Couples
Severe Chronic Physical and Mental Diseases in Each of the Couples
Secondary Infertility Diagnosed in Each of the Couples
Experience of Extreme Stress in Each of the Couples (During the Last Six Months)
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
Randomization description
The Samples Are Selected As Available and Then the People Are Randomly Assigned to Two Control and Intervention Groups in Blocks of size 4 (4 people). Random Blocks Will Be Generated Through the Site (www.sealedenvelope.com). For Concealment, the Randomized Sequences Are Placed in Sealed Envelopes and Numbered Sequentially.
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
Alborz University of Medical Sciences
Street address
North Taleghani Blvd; Taleghani Square
City
Karaj
Province
Alborz
Postal code
3149779453
Approval date
2023-07-02, 1402/04/11
Ethics committee reference number
IR.ABZUMS.REC.1402.095
Health conditions studied
1
Description of health condition studied
Midwife led consuling
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Women's Fertility Motivation
Timepoint
Measuring the Fertility Motivation Score of Women Before and One Month After the Intervention
Method of measurement
Miller's Fertility Motivation Questionnaire with Two Positive Dimensions Including 34 Questions and Negative Including 19 Questions
2
Description
Women's Empowerment
Timepoint
Measuring Women's Empowerment Before and One Month After the Intervention
Method of measurement
Dr. Cohen's Empowerment of Women Questionnaire with 38 Questions in Four Cultural, Individual - Family, Social and Family Planning Dimensions
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: The Intervention Group With 65 People Who Will Receive the Intervention Include of Face-to-Face Counseling in the Form of 4 One-Hour Sessions (15-20 people). The Content of the Child-Bearing Educational Counseling Sessions Will Be Compiled by the Research Team with an Emphasis on the Contents of the Questionnaires of Fertility Motivations and Women's Empowerment Based on the Guidelines of the Ministry of Health As Well As Reliable Sources and Sites, and Will Include Discussions in the Field of Self-Knowledge, Planning, Factors Affecting the Correct Decision-Making for Fertility and Child-Bearing, and the Importance of Women's Independence to Make Free Decisions on Various Reproductive Health Issues, Including the Aspect of Family Planning. Each Counseling Session Will Include the Presentation of Appropriate Content, Assignments and Feedback to the Participants, As Well As a Review of the Previous Sessions.
Category
Lifestyle
2
Description
Control Group: Including 65 People Who Will Receive Routine Care of the Centers.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Health deputy of Kashan
Full name of responsible person
Mehdi Delavari
Street address
Shamshad 13 St; Kashan Phase 2
City
Kashan
Province
Isfehan
Postal code
8713783976
Phone
+98 31 5542 0001
Email
info@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Razieh Lotfi
Street address
Safarian alley; 45 Meteri-e-Gulshahr
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Email
Research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Alborz 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
Alborz University of Medical Sciences
Full name of responsible person
Zahra Mehdizadeh Tourzani
Position
Instructor of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
North Taleghani Blvd; Taleghani Square, Alborz University of Medical Sciences
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3428 7425
Fax
Email
zahramehdizadeh_t@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Zahra Mehdizadeh Tourzani
Position
Instructor of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
North Taleghani Blvd; Taleghani Square, Alborz University of Medical Sciences
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3428 7425
Fax
Email
zahramehdizadeh_t@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Zahra Mehdizadeh Tourzani
Position
Instructor of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
North Taleghani Blvd; Taleghani Square, Alborz University of Medical Sciences
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3428 7425
Fax
Email
zahramehdizadeh_t@yahoo.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
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
Undecided - It is not yet known if there will be a plan to make this available