Determining the effect of counseling with the Good Enough Sex Model (GES) on sexual function and sexual intimacy in pregnant women
Design
This intervention is a randomized controlled clinical trial with parallel groups. The sample (60 study participants) will be randomized using block randomization (30 in the control group and 30 in the intervention group).
Settings and conduct
Eligible women referring to the Dezful city health center will enter the study after the intervention is explained to them.
Participants/Inclusion and exclusion criteria
Informed consent, literacy, low-risk pregnancy, presence of spouse
Intervention groups
For the intervention group, 4 weekly GES model-based sexual counseling sessions will be held at the health center. During the clinical trial, the control group will benefit from routine pregnancy care, and no intervention will be performed by the research team. However, after the trial, the educational content will be provided to them.
Main outcome variables
Sexual function, sexual intimacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170607034381N10
Registration date:2025-05-24, 1404/03/03
Registration timing:registered_while_recruiting
Last update:2025-05-24, 1404/03/03
Update count:0
Registration date
2025-05-24, 1404/03/03
Registrant information
Name
Ferdos Pelarak
Name of organization / entity
Dezful Azad University
Country
Iran (Islamic Republic of)
Phone
+98 916 941 7091
Email address
pelarak.f@dums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-05-20, 1404/02/30
Expected recruitment end date
2025-08-21, 1404/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counseling with the good enoughsex model (GES) on sexual function and sexual intimacy of pregnant women
Public title
The impact of counseling on the performance and intimacy of pregnant women.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
First pregnancy
Informed consent
Low-risk pregnancy
Presence of spouse
Literacy
Exclusion criteria:
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
After determining the sequences, individuals will be selected using a simple random method and assigned to two groups using block randomization with a block size of 4. The procedure is as follows: the group assignments, based on the generated sequence, will be placed in sealed envelopes, and the envelopes will be numbered. For each individual, according to their order of entry into the study, the corresponding numbered envelope will be opened, and they will be assigned to one of the groups without the participant being aware.
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
Research Ethics Committee of Shahroud University of Medical Sciences
Street address
Hafte Tir Square
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷۷۳۹۴۳
Approval date
2025-04-13, 1404/01/24
Ethics committee reference number
IR.SHMU.REC.1404.005
Health conditions studied
1
Description of health condition studied
Sexual dysfunction
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction not due to a substance or known physiological condition
2
Description of health condition studied
Sexual intimacy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sexual Function
Timepoint
Before the intervention, immediately after the intervention, one month after the intervention
Method of measurement
Rosen Sexual Function Questionnaire
Secondary outcomes
1
Description
Sexual Intimacy
Timepoint
Before the intervention, immediately after the intervention, one month after the intervention
Method of measurement
Botlani Sexual Intimacy Questionnaire
Intervention groups
1
Description
Intervention group: Implementing the first three dimensions of the GES model and explaining the importance of sexual activity; teaching the definition of sexual satisfaction and function, and the factors affecting it; describing the four stages of the sexual response cycle; explaining the impact of pregnancy on sexual function and its mechanism; correcting misconceptions and superstitions about sexual intercourse and creating an optimistic attitude; reviewing previous learning and summarizing the previous session; and implementing dimensions four, five, and six of the GES model; teaching healthy nutrition and performing Kegel exercises; teaching mindfulness skills and concentration exercises, and a three-minute breathing exercise; providing a timed table for noting the individual's thoughts and mindset during pleasant sexual experiences, unpleasant experiences, aversion, pain, and muscle contractions in the body; teaching how to enjoy each other; implementing the seventh, eighth, and ninth dimensions of the GES model; considering the problems and concerns noted by clients during the previous weeks; counseling for physical adaptation to anatomical changes; helping to maintain verbal and emotional connection with the spouse and emphasizing the importance of foreplay and lovemaking between couples; describing and examining the pattern of sexual changes and potential physical problems during pregnancy and focusing on the fivefold goal in orgasm; identifying five principles for sexual intercourse; accepting multiple intentions from both parties; avoiding unilateral and inflexible goals and clarifying the sexual agenda; describing different coital positions and styles of sexual stimulation; combining styles and creating variety in the relationship. Implementing the tenth, eleventh, and twelfth dimensions of the GES model; counseling and education about the physical and psychological differences between men and women in each stage of the sexual cycle; teaching communication skills; teaching skills for creating and maintaining intimacy.
Category
Behavior
2
Description
Control group: Routine pregnancy care
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Center No. 3
Full name of responsible person
Fatemeh Mohtadi
Street address
Saberin Avenue
City
Dezful
Province
Khouzestan
Postal code
۶۴۶۱۶۶۵۱۴۵
Phone
+98 61 4223 1072
Email
Fatememohtadi713@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Hosein Ebrahimi
Street address
Hafte Tir Square
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷۷۳۹۴۳
Phone
+98 23 3239 5054
Email
ebrahimi@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Fatemeh Mohtadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Hafte Tir Square
City
Shahroud
Province
Semnan
Postal code
36147-73943
Phone
+98 23 3239 5054
Email
Fatememohtadi713@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Fatemeh Mohtadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Hafte Tir Square
City
Shahroud
Province
Semnan
Postal code
36147-73943
Phone
+98 23 3239 5054
Email
fmohtadii21@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Fatemeh Mohtadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Hafte Tir Square
City
Shahroud
Province
Semnan
Postal code
36147-73943
Phone
+98 23 3239 5054
Email
Fatememohtadi713@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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after unidentifiable individuals
When the data will become available and for how long
12 months after the results are published
To whom data/document is available
Researchers working in scientific and academic institutions
Under which criteria data/document could be used
En According to the terms and conditions of Shahroud Medical Sciences University, the data can be used
From where data/document is obtainable
Fateme Mohtadi fatememohtadi713@gmail.com
What processes are involved for a request to access data/document
Written request and consent of the Executor of the project and colleagues