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Investigating the effect of men's supportive educational counseling on their desire to redundant childbearing , couples' sexual intimacy and fear of childbirth among prime pregnant

Protocol summary

Study aim
Determining the effect of educational-support counseling for men with pregnant first wives on their willingness to have children again, couples' sexual intimacy and women's fear of childbirth
Design
A randomized clinical trial was conducted on 78 husbands of first-time pregnant women, in 2 intervention and control groups, for randomization, the online random sequence generation software was used.
Settings and conduct
Counseling will be done by the trained student in health centers in a quiet environment with proper ventilation and sufficient light. The second group, as a control group, will only receive routine clinic care. The questionnaires will be completed two weeks after the end of the intervention by the participants of the two groups of educational counseling and support and control. And in order to comply with the ethical principles, all the contents of the counseling sessions will be made available to all people in the control group after the end of the study.
Participants/Inclusion and exclusion criteria
Entry conditions: no history of infertility, no history of pregnancy, having a gestational age of 16-25 weeks, no midwifery ban on intercourse, having a singleton pregnancy, not suffering from chronic diseases, not participating in childbirth preparation classes. Exclusion conditions: occurrence of premature birth, indications for cesarean section, occurrence of psychological trauma during the study, unwillingness to continue the study, participation in other psychological counseling classes during the study.
Intervention groups
The intervention group will receive educational-supportive counseling in 3 sessions. The second group, as a control group, will receive only the routine interventions of the clinic.
Main outcome variables
Sexual intimacy of couples, fear of childbirth and desire to have children again

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151103024866N19
Registration date: 2024-05-29, 1403/03/09
Registration timing: registered_while_recruiting

Last update: 2024-05-29, 1403/03/09
Update count: 0
Registration date
2024-05-29, 1403/03/09
Registrant information
Name
Katayoun Alidousti
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5219
Email address
alidoosti@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-08, 1403/01/20
Expected recruitment end date
2025-03-10, 1403/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of men's supportive educational counseling on their desire to redundant childbearing , couples' sexual intimacy and fear of childbirth among prime pregnant
Public title
The effect of educational-supportive counseling on the desire to redundant childbearing, couples' sexual intimacy and fear of childbirth
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being at least 18 years old in men Age 18 to 35 years in pregnant women Not having a history of infertility in men and women Cohabitation with spouse Ability to read and write Having no history of any physical-psychological disorder or addiction to smoking, alcohol, or drugs in men and women Monogamy and Iranian race The experience of becoming a father for the first time No history of pregnancy Having a gestational age of 16-25 weeks Absence of obstetric prohibitions for intercourse (such as placenta previa, bleeding during pregnancy and threat of abortion or premature birth) Having a low-risk singleton pregnancy Not suffering from chronic diseases (heart, lung, kidney, blood pressure, diabetes, etc.) Failure to participate in childbirth preparation classes
Exclusion criteria:
Incidence of premature birth or pregnancy risk complications Indications for cesarean section (total placental abruption, genital herpes, microcephalic or macrosomatic fetus, breech presentation, etc.) Occurrence of psychological trauma during the study Unwillingness to continue studying and the absence of spouses in the supportive educational counseling group for more than one session
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 78
Randomization (investigator's opinion)
Randomized
Randomization description
The random sampling method will be simple, in such a way that a list of the spouses of the first pregnant women will be obtained through the Sib system and in order to randomize the selection, it will be assigned to the participants from number 1 to 78 respectively, then using Random block allocation method with blocks of six people will be divided into two groups of 39 people. In order to hide the process of random allocation and prevent selection bias, this action will be carried out by someone other than the main researcher after preparing the final list, and the researcher will be obliged to act exactly according to it.
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 Kerman University of Medical Sciences
Street address
Razi Nursing and Midwifery Faculty., Kerman University of Medical Sciences Campus., Haft Bagh Alavi Highway
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2023-09-26, 1402/07/04
Ethics committee reference number
IR.KMU.REC.1402.211

Health conditions studied

1

Description of health condition studied
sexual intimacy
ICD-10 code
F66
ICD-10 code description
Other sexual disorders

2

Description of health condition studied
fear of child birth
ICD-10 code
F40.232
ICD-10 code description
Fear of other medical care

Primary outcomes

1

Description
Fear of childbirth score from Vizhma and Rose questionnaire
Timepoint
before the start of the intervention and two weeks after the end of the intervention
Method of measurement
Fear of childbirth score from Vizhma and Rose questionnaire

2

Description
Sexual intimacy score of couples
Timepoint
before the intervention and two weeks after the end of the intervention
Method of measurement
Bagaroozi sexual intimacy questionnaire and sexual intimacy scale

3

Description
The percentage of people whose answer to the question of their desire to have children again is yes.
Timepoint
Before the intervention and two weeks after the end of the intervention
Method of measurement
Ask a question and get a yes or no answer

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: They will receive educational-supportive counseling in 3 sessions of 90 minutes.
Category
Lifestyle

2

Description
Control group: This group will only receive routine clinic care and will not receive other services and interventions. And in order to comply with the ethical principles, all the contents of the counseling sessions will be made available to all people in the control group after the end of the study.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Afzalipur Medical Education Center
Full name of responsible person
Fatemeh Aminian
Street address
Imam Khomeini Highway, next to Shahid Bahonar University, Afzalipur Medical Education Center
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
amiiniianf1996@gmail.com
Web page address
http://bankpezeshkan.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abedin Iranpour
Street address
Deputy of research and technology., Somayeh Crossroads
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3719
Email
vcr@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Katayoun Alidousti
Position
Instructor of the midwifery faculty
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Department of Midwifery., Razi Faculty of Nursing and Midwifery., Kerman University of Medical Sciences campus.,Haft Bagh Alavi
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
kalidousti@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Katayoun Alidousti
Position
Instructor of the midwifery faculty
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Department of Midwifery., Razi Faculty of Nursing and Midwifery., Kerman University of Medical Sciences campus.,Haft Bagh Alavi
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
kalidousti@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Katayoun Alidousti
Position
Instructor of midwifery faculty
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Department of Midwifery., Razi Faculty of Nursing and Midwifery., Kerman University of Medical Sciences campus.,Haft Bagh Alavi
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
kalidousti@gmail.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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