Protocol summary

Study aim
determining the impact of sexual health model counseling on sexual compatibility and childbearing intention of new women
Design
the clinical trial was performed with pre - test and post - test and active control group. blinding in this study will not be possible . random allocation will be made using online allocation.
Settings and conduct
this study was an interventional study of a parallel randomized clinical trial with pre - test - post - test and active control group which will be done on women referring to the comprehensive health center of yazd city. women with poor to moderate sexual compatibility and inclusion criteria in the study were allocated to two intervention groups ( 32 person in person and virtual consulting ) and control group ( 32 persons of virtual education package ) . the sessions will be held in four sessions of group counseling for 90 minutes . immediately after consulting and also 4 weeks later, both groups will complete the sexual compatibility questionnaire and intention to childbearing online .
Participants/Inclusion and exclusion criteria
women aged 15 to 45 years old , married to 12 - 3 months of marriage in the apple system of health center of yazd city .
Intervention groups
32 people in the intervention group will receive sexual health counseling for 4 sessions of 90 minutes . the intervention group in the first session , in the form of training in the form of training and the rest of the sessions , will be placed in person under training and by presence or virtual consulting . education is based on sexual health model and focusing on sexual compatibility in groups 6 - 8 . the active control group also received training on sexual health dimensions and sexual compatibility and childbearing as a weekly and virtual educational package .
Main outcome variables
Sexual compatibility, intention to have children

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20251206068227N1
Registration date: 2026-08-03, 1405/05/12
Registration timing: retrospective

Last update: 2026-08-03, 1405/05/12
Update count: 0
Registration date
2026-08-03, 1405/05/12
Registrant information
Name
Fatemeh Poorhakkak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3624 5975
Email address
f.poorhakkak242@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-03-21, 1405/01/01
Expected recruitment end date
2026-07-23, 1405/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of counseling based on the sexual health model on the Sexual compatibility and Intention to have children of newly married women
Public title
Investigating the effect of counseling based on the sexual health model on the Sexual compatibility and Intention to have children of newly married women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being Iranian and literate Being monogamous Having regular sexual activity (at least once a week) Having weak to moderate sexual compatibility based on the Hurlburt Sexual Compatibility Questionnaire (score less than 64) A maximum of one year has passed since the marriage Having access to a smartphone and the internet 7. Permanent marriage Permanent marriage
Exclusion criteria:
Previous marital history for both partners Experience of a severe problem or stressful event (such as the death of a loved one or financial bankruptcy) in the past 6 months for both partners (self-reported) Having a physical illness (including no sexual dysfunction, sexually transmitted diseases, and medical illnesses such as diabetes) or a major mental illness based on the couples' self-report History of treatment for sexual dysfunction by a psychologist, urologist, or gynecologist Participation in similar sexual counseling courses in the year before the study (both groups received only premarital sexual counseling) Presence of acute marital conflict (including lawsuits, infidelity) History of use of drugs, alcohol, and sexual enhancement drugs or drugs that affect sexual function Presence of a known abnormality in sexual anatomy and function Pregnancy (self-reported) Forced marriage
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
the sample size is 64 .after the number of qualified people has reached 64 , the random allocation of block is done using the online allocation online site ( http://www.randomization.com ) and 32 people in the intervention group ( 32 members of the first session under training in the form of educational presence classes ) and the rest of the sessions will be placed online via sky and 32 people in active control group ( 32 people ) .participants are informed that the probability of their placement in each group of control and intervention groups is 50 % .the random allocation process consists of two stages : 1 ) generating a pre - nasal random assignment , using a computer random number table .the table of random numbers is used to use the online method in online software .2 ) concealment : the implementation of the sequence in a way that masks the interventions until the participants are formally assigned to their groups ( by one of the health care providers outside the research team ) .
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
We have two intervention and control groups. The intervention group (32 people will be trained in the first session in the form of in-person educational classes and the remaining sessions will be in-person or virtual online via Sky Room, depending on the preference of the people) and 32 people will be placed in the active control group (32 people will receive a virtual training package).

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Yazd University of Medical Sciences
Street address
Yazd, Safaiyeh, Bu Ali St., opposite the Infertility Center
City
yazd
Province
Yazd
Postal code
7744389168
Approval date
2025-11-05, 1404/08/14
Ethics committee reference number
IR.SSU.REC.1404.121

Health conditions studied

1

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

2

Description of health condition studied
Intention to have children
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
sexual compatibility score in Hurlbert sexual compatibility questionnaire
Timepoint
before intervention and 4 and 8 weeks after intervention
Method of measurement
Hurlbert sexual compatibility questionnaire

2

Description
the mean of childbearing intention in the questionnaire of childbearing intention
Timepoint
before intervention and 4 and 8 weeks after intervention
Method of measurement
questionnaire of effective component on childbearing intention

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: the intervention group received counseling and question and response therapy sessions during 4 sessions of 90 - minute sessions of counseling that will be received in the first session of counseling in the form of educational presence classes and the rest of sessions , depending on the willingness of individuals under training or virtual consulting . education is based on sexual health model and focusing on sexual adaptation in groups 6 - 8 .
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
haji maghsoudi health center ( centre for marriage consulting )
Full name of responsible person
fatemeh poorhakkak
Street address
Yazd, Safaieh, Ashraf Martyrs Boulevard, Javadalaameh St., Kherad St.
City
yazd
Province
Yazd
Postal code
۸۹۱۳۷۸۳۱۱۵
Phone
+98 35 3838 0923
Email
F.poorhakkak242@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mehran Karimi
Street address
Yazd, Bahonar Square, Central Building of Shahid Sadoughi University of Medical Sciences
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Fax
+98 35 3725 4750
Email
info@ssu.ac.ir
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
fatemeh poorhakkak
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Chamran Street, 17th Shahrivar Street
City
yazd
Province
Yazd
Postal code
8914687795
Phone
36245975
Email
F.poorhakkak242@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mahshid Bekai
Position
Master of Midwifery Consulting
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Bu Ali Street, Faculty of Nursing and Midwifery
City
Yazd
Province
Yazd
Postal code
7744389168
Phone
+98 35 3824 1751
Email
mah_bokaie@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
fatemeh poorhakkak
Position
Master's degree student in consulting in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Chamran Street, 17th Street, Shahrivar
City
yazd
Province
Yazd
Postal code
8914687795
Phone
36245975
Email
F.poorhakkak242@gmail.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
All data, including proposals, raw data, and project reports
When the data will become available and for how long
Data is accessible via request from the legal system for two years, 6 months after publication.
To whom data/document is available
All natural and legal persons will have access upon request to the Vice President for Research of Yazd University of Medical Sciences.
Under which criteria data/document could be used
For legal matters and the need to use data in future studies
From where data/document is obtainable
Fatemeh Pourhakkak, Mahshid Bokaei
What processes are involved for a request to access data/document
After submitting the application to the Yazd Medical Sciences Research and Technology Vice-Chancellor, a call will be issued to the executor to provide data.
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