Determining the effect of Motivational interviewing on the Attitude and Intention to childbearing of female healthcare personnel
Design
This study is a parallel randomized clinical trial in the form of pre-test, post-test and one-month follow-up, in which 56 eligible participants will be selected by random and purpose-based sampling and will be randomly assigned to two intervention and control groups.
Settings and conduct
The intervention in Feridounshahr health and treatment network will be held during 5 sessions of 45 minutes and in 5 consecutive weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Female healthcare personnel of reproductive age (15 to 49 years), Having informed consent to participate in the study, Being married, Having no children or having one or two children, Use of contraceptive methods, Not having primary or secondary infertility. Exclusion criteria: Participation in the relevant training course during the study, The presence of absolute contraindications for pregnancy, Suffering from mental illnesses, Using any tobacco and drugs and drinking alcohol, Occurrence of stressful events during the last 6 months.
Intervention groups
In the intervention group, counseling is done based on Motivational interview during 5 sessions of 45 minutes and weekly and online and they will also be provided with an educational pamphlet on childbearing. Also, the intervention group is invited to participate in the first and second session in person at Fereydunshahr Health and Treatment Network. The control group will be given an educational pamphlet with the content of childbearing and its benefits, the consequences of delaying childbearing, and childbearing facilities according to the population youth law.
Main outcome variables
Change in mean scores of childbearing intention in reproductive age women
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230308057654N1
Registration date:2023-03-16, 1401/12/25
Registration timing:prospective
Last update:2023-03-16, 1401/12/25
Update count:0
Registration date
2023-03-16, 1401/12/25
Registrant information
Name
Akram Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5262 2533
Email address
a.rahimi@stu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-09, 1402/01/20
Expected recruitment end date
2023-08-11, 1402/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Motivational interviewing on the Attitude and Intention to childbearing of female healthcare personnel
Public title
Investigating the effect of Motivational interviewing on the Attitude and Intention to childbearing
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Female healthcare personnel of reproductive age (15 to 49 years)
Having informed consent to participate in the study
Being married
Having no children or having one or two children
Use of contraceptive methods
Not having primary or secondary infertility
Exclusion criteria:
Participation in the relevant training course during the study
The presence of absolute contraindications for pregnancy, such as class 3 and 4 heart valve failure and any type of acute heart disease, AIDS, etc.
Suffering from mental illnesses (such as schizophrenia, severe depression, psychosis, etc.) under medical treatment based on medical record information or statements
Using any tobacco and drugs and drinking alcohol
Occurrence of stressful events during the last 6 months (Migration, divorce, death of relatives...)
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:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Qualified personnel will be randomly selected in 2 health centers and 20 health houses under the central coverage of Fereydunshahr and 5 departments of Hazrat Rasool Akram Fereydunshahr hospital based on inclusion and exclusion criteria. Then, using the random numbers table and through the software (www.Random.org/sequences) with random assignment, the participants will be placed in two intervention and control groups. At the beginning of the study, participants are told that they have the same chance to be in the intervention or control group. Then, the people of the intervention group will be invited to participate in counseling sessions.
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 Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Bahonar Square; Yazd
City
Yazd
Province
Yazd
Postal code
8916189165
Approval date
2023-03-01, 1401/12/10
Ethics committee reference number
IR.SSU.REC.1401.110
Health conditions studied
1
Description of health condition studied
Counseling of attitude to childbearing, Counseling of intention to childbearing
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Change in mean scores of childbearing intention in reproductive age women
Timepoint
In the baseline, completion of the intervention (End of the fifth week) and in the follow-up period (4 weeks after the completion of the intervention)
Method of measurement
Intention to childbearing questionnaire
Secondary outcomes
1
Description
Change in mean scores of Attitudes towards childbearing in women of reproductive age
Timepoint
In the baseline, completion of the intervention (End of the fifth week) and in the follow-up period (4 weeks after the completion of the intervention)
Method of measurement
Attitude towards childbearing questionnaire
Intervention groups
1
Description
Intervention group: People in the intervention group will participate in 5 online counseling sessions in the form of Motivational interviews in 5 consecutive weeks, one session a week and each session will last 45 minutes. The content of the sessions includes: Discovering the positive and negative aspects of maintaining behavior and changing behavior, Exercise mental precipitation of short-term and long-term profits and losses, Reframing and defining the clients' failures and failures from her own point of view, Summoning the personal abilities of the clients, Checking the list of goals written in the first session, Answers to all questions, Summary and summation of the exercises of the previous sessions in the form of perspective exercises and preparation for the start of the behavior change program.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Rasool Akram Hospital
Full name of responsible person
Maryam Dafei
Street address
Basij Blvd
City
Fereydunshahr
Province
Isfehan
Postal code
7361185917
Phone
+98 31 5759 2042
Email
marydafei@gmail.com
2
Recruitment center
Name of recruitment center
Fereydunshahr health and treatment Network
Full name of responsible person
Maryam Dafei
Street address
Dr. Ali Shariati St
City
Fereydunshahr
Province
Isfehan
Postal code
8591837784
Phone
+98 31 5759 2035
Email
feridonshahr-health@mui.ac.ir
3
Recruitment center
Name of recruitment center
Vahdat Abad Comprehensive Health Center
Full name of responsible person
Akram Rahimi
Street address
Fanniherfeie St
City
Fereydunshahr
Province
Isfehan
Postal code
57591292
Phone
+98 31 5262 2533
Email
akramrahimi.6394@yahoo.com
4
Recruitment center
Name of recruitment center
Barf Anbar comprehensive health center
Full name of responsible person
Akram Rahimi
Street address
The beginning of Imam Khomeini Blvd
City
Fereydunshahr
Province
Isfehan
Postal code
5361185917
Phone
+98 31 5262 2533
Email
akramrahimi.6394@yahoo.com
5
Recruitment center
Name of recruitment center
Comprehensive health center of Sibak village
Full name of responsible person
Akram Rahimi
Street address
Sibak village entrance
City
Fereydunshahr
Province
Isfehan
Postal code
4761185917
Phone
+98 31 5262 2533
Email
akramrahimi.6394@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Alireza Moradi
Street address
Central Organization of Shahid Sadoughi University of Medical Sciences, Yazd, Dr. Bahonar Square, Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3726 3733
Fax
+98 35 3726 3732
Email
alirezampr@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Maryam Dafei
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Bouali ave
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
marydafei@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Maryam Dafei
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Bouali ave
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
marydafei@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Maryam Dafei
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Bouali ave
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
marydafei@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All individual data of study participants can be shared after de-identification.
When the data will become available and for how long
After results publication
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions, and people working in industry can apply to receive them.
Under which criteria data/document could be used
Scientific usage
From where data/document is obtainable
marydafei@gmail.com
What processes are involved for a request to access data/document