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Investigating the Effect of Training and Counseling based on the Self-management Empowerment Model on Childbearing Motives, Marital Satisfaction and Sexual Satisfaction in Couples

Protocol summary

Study aim
The effect of education and counseling based on the self-management empowerment model on childbearing motives, marital satisfaction and sexual satisfaction in couples.
Design
Clinical trial with test group, control group, without blinding, randomized
Settings and conduct
The target population is couples referring to Bushehr health centers, the research environment of Bushehr Comprehensive Health Centers. The research samples will be selected from the centers (based on the allocation to share sampling that was explained in the sampling section). They will be randomly divided into two control and test groups. Test forms will be designed in Google Doc, informed consent form, demographic information form, and a questionnaire on motives for having children, marital satisfaction, and sexual satisfaction, then a pre-test will be conducted in the test group. and control, intervention is not done in the control group. In the intervention test group, self-management empowerment will be done face-to-face, and then the post-test will be done in both groups, and data analysis will be done using appropriate software.
Participants/Inclusion and exclusion criteria
Inclusion: absence of pregnancy; being married; being Iranian; having informed consent; age 18-40 Years old. Exit criteria: secondary infertility; physical and mental illness; failure to attend more than one training session.
Intervention groups
In the intervention group, four training and consultation sessions based on the self-management empowerment model will be held; after completing the study, the control group will be given a training booklet.
Main outcome variables
1) Childbearing motivation score with childbearing motivation questionnaire 2)Marital satisfaction score with the Enrich Marital Satisfaction Questionnaire 3) Sexual satisfaction score with the Larson Sexual Satisfaction Questionnaire

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220830055827N2
Registration date: 2023-12-09, 1402/09/18
Registration timing: prospective

Last update: 2023-12-09, 1402/09/18
Update count: 0
Registration date
2023-12-09, 1402/09/18
Registrant information
Name
Farahnaz Kamali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3345 0187
Email address
f.kamali@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-10, 1402/09/19
Expected recruitment end date
2023-12-31, 1402/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Training and Counseling based on the Self-management Empowerment Model on Childbearing Motives, Marital Satisfaction and Sexual Satisfaction in Couples
Public title
Investigating the Effect of the Self-management Empowerment Model on Childbearing Motives, Marital Satisfaction and Sexual Satisfaction
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being Literate Being Iranian Being Married Living with a Spouse Age 18-40 Years Not Pregnant Not having a Medical Prohibition for Pregnancy Consent of Wife and Husband to Participate in the Study
Exclusion criteria:
Failure to Participate in more than one Counseling Session Participate in Similar Courses at the Same Time Having Secondary Infertility based on Self-report Physical and Mental Illness in a Person or Spouse based on Self-report
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 128
Randomization (investigator's opinion)
Randomized
Randomization description
First, sampling will be easy and then random allocation will be done in two groups, intervention and control. Blocking will be done using blocks of eight; In this way, the letter A will be assigned to the intervention group and the letter B will be assigned to the control group, and then blocking will be done using Random Allocation software. In each center, sampling will be done in the form of allocation to shares. That is, the number of samples is determined according to the population covered by each center.
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 Bushehr University of Medical Sciences
Street address
School of Midwifery Nursing, Bushehr University of Medical Sciences, Salman Farsi St., Bushehr
City
Bushehr
Province
Boushehr
Postal code
7518759577
Approval date
2023-07-11, 1402/04/20
Ethics committee reference number
IR.BPUMS.REC.1402.077

Health conditions studied

1

Description of health condition studied
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Childbearing Motivation Score from the Childbearing Motivation Questionnaire
Timepoint
At the beginning of the study (before the start of the intervention) and two months after the end of the intervention
Method of measurement
Childbearing Motivation Questionnaire

2

Description
Marital Satisfaction score from Enrich Marital Satisfaction Questionnaire
Timepoint
At the beginning of the study (before the start of the intervention) and two months after the end of the intervention
Method of measurement
Enrich Marital Satisfaction Questionnaire

3

Description
Sexual Satisfaction score from Larson's sexual Satisfaction Questionnaire
Timepoint
At the beginning of the study (before the start of the intervention) and two months after the end of the intervention
Method of measurement
Larson sexual Satisfaction Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Training and counseling of the self-management empowerment model in four sixty-minute sessions, In an interview manner, During two weeks, there will be two meetings in person each week. Continue the intervention in the form of telephone follow-up in six weeks and a meeting every week to answer questions.
Category
Behavior

2

Description
Control group: There is no intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
All the clinics of Bushehr city
Full name of responsible person
Farhanaz Kamali
Street address
City level clinics, Bushehr, Bushehr province
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 912 936 2377
Email
aliyeh.rafiei1400@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Akram Farhadi
Street address
Deputy of research and technology, Bushehr University of Medical Sciences, Salman Farsi St.
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 912 936 2377
Email
ak.farhadi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Boushehr 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
Boushehr University of Medical Sciences
Full name of responsible person
Farhanaz kamali
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
School of Midwifery Nursing, Bushehr University of Medical Sciences, Salman Farsi St.
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 0187
Email
Farhanazkamali2006@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Farahnaz kamali
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
School of Midwifery Nursing, Bushehr University of Medical Sciences, Salman Farsi St.
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 0187
Email
Farahnazkamali2006@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Farahnaz kamali
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
School of Midwifery Nursing, Bushehr University of Medical Sciences, Salman Farsi St.
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 0187
Email
Farahnazkamali2006@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
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