Determining the effectiveness of sexual counseling based on the Good Enough Sexual Experience model on sexual self-care and sexual function of infertile women
Design
Randomized clinical trial, including 206 people in two intervention and control groups, block random allocation method with 6 blocks as single blinding
Settings and conduct
The intervention will involve two groups at the Fatima Al-Zahra Infertility Center in Babol City: the "GES" and the control group.
Blinding the participants and the researcher responsible for sampling will not be feasible. Only the data analyst will remain blinded.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Iranian nationality; Age between 20 and 40 years; Possession of basic literacy skills; Stable marital life with a spouse and consistent sexual activity (at least over the past four weeks); a permanent marriage; Infertility; No history of genital infections; Absence of physical conditions or psychiatric disorders under medical supervision or treatment as confirmed by medical records and self-reports; No substance abuse, including alcohol, cigarettes, hookah, or illicit drugs; No use of medications that may cause sexual dysfunction (e.g., barbiturates, benzodiazepines as confirmed by medical records and self-reports; A score of 26.5 or lower on the FSFI; Not in a polygamous relationship; No plans to undergo fertility treatments within the next two months
Exclusion Criteria:
Pregnancy during the study; Failure to participate in completing the questionnaires; Failure to answer more than 10% of the questionnaire items; Participation in psychological interventions within the past three months; Experience of a stressful life event in the past three months
Intervention groups
Conducting sessions, according to sexual counseling based on the Good Enough Sexual Experience (GES) model
Main outcome variables
Self-care, and sexual function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250202064609N1
Registration date:2025-02-19, 1403/12/01
Registration timing:prospective
Last update:2025-02-19, 1403/12/01
Update count:1
Registration date
2025-02-19, 1403/12/01
Registrant information
Name
Yasamin Nami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 902 729 3655
Email address
21yasamin11nami@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-03-05, 1403/12/15
Expected recruitment end date
2026-03-06, 1404/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of sexual counseling utilizing the 'Good-Enough Sex Model' (GES) on the sexual self-care and sexual function of infertile wome
Public title
The effectiveness of sexual counseling utilizing the 'Good-Enough Sex Model' (GES) on the sexual self-care and sexual function of infertile women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian nationality
Age 20 - 40 years
Possessing at least the ability to read and write and understand and answer questions
Constant life with partner, having stable sexual activity (at least the last four weeks)
Spouse availability, permanent marriage
Infertility according to the World Health Organization definition
No history of genital infections
No physical problems (spinal cord injury, limb defects)
No history of physical illness (diabetes, cardiovascular disease, blood pressure, thyroid disease, Addison's, Cushing's), and psychiatric disorders under medical supervision or treatment such as severe depression, psychosis, bipolar disorder based on medical records and self-reporting.
No substance abuse, use of alcohol, cigarettes, hookah, and drugs.
Avoid taking medications that cause sexual dysfunction, such as barbiturates, benzodiazepines (diazepam, oxazepam, chlordiazepoxide), antidepressants, and antihypertensives, according to the doctor's record.
Score 26.5 or lower on the Women's Sexual Function Questionnaire(FSFI)
Not being polygamous
No infertility treatment for the next two months
Exclusion criteria:
Getting pregnant while studying
Failure to participate in completing the questionnaire
Failure to answer more than 10% of the questionnaire questions
Participation in psychological interventions (participation in psychotherapy sessions, relaxation techniques, yoga) in the last 3 months
Experiencing a stressful event in the last three months (death or acute illness of a close relative, major change in life situation)
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
216
Randomization (investigator's opinion)
Randomized
Randomization description
Our sample size is 216 participants, who were randomly divided into two groups: 108 in the intervention group and 108 in the control group. The random allocation method used was block randomization, designed by the methodologist using the SealedEnvelope.com website. The number of blocks was set at 6. According to the block randomization protocol, participants were assigned to one of the two groups—1: GES (intervention) or 2: control—in a 1:1 ratio, ensuring that the researcher could not predict which group the next participant would be assigned to.
To conceal the random allocation, sealed opaque envelopes containing a random sequence were used in this study. First, 36 opaque paper envelopes were prepared (to ensure the contents remained unclear). Each random sequence was recorded on a card, and the cards were placed inside the envelopes in order. The envelopes were then sealed and placed in a box in sequential order. The random assignment was solely managed by the principal investigator, who was the only person aware of the relevant codes. The order of the envelopes corresponded to the randomization list in the box. When the interviewer confirmed a participant’s eligibility, the principal investigator provided them with the next envelope in the sequence.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the nature of the study, blinding the participants and the researcher responsible for sampling will not be feasible. For data analysis, a methodology and biostatistics expert, who is independent of the study and unaware of all procedures conducted, will be utilized
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Babol university of Medical Sciences
Street address
Babol University of Medical Sciences, Ganj Afroz Street, Babol, Mazandaran
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶۴۷۷۴۵
Approval date
2025-01-20, 1403/11/01
Ethics committee reference number
IR.MUBABOL.REC.1403.155
Health conditions studied
1
Description of health condition studied
Infertile women,Sex Counseling, , Sexual function ,Good Enough Sex Model, Sexual self-care, Sexual Quality of Life
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sexual function
Timepoint
before and one month after the intervention
Method of measurement
Female Sexual Function Index (FSFI): This questionnaire was designed and validated by Rosen et al. in 1997 and includes 19 closed-ended items in 6 domains: 1- Desire 2- Psychological arousal 3- Wetness 4- Orgasm 5- Satisfaction and 6- Sexual pain, which is based on a five-point Likert scale. The Persian version of the Sexual Function Index is a reliable and valid tool for assessing female sexual function. The reliability of the scale was calculated through stability analysis or internal consistency coefficient. Cronbach's alpha coefficient is ≤ 0.8, which indicates good reliability of this tool. Regarding the scoring method, according to the questionnaire designer's instructions, the scores of each domain are obtained by adding the scores of the questions in each domain and multiplying it by the number of factors. However, since the number of questions in the domains is not equal in the questionnaire, the scores of the questions in each domain are first added together to weight the domains together and then multiplied by the number of factors. The total score of the scale is obtained by adding the scores of the six domains together. In this way, the scoring is such that a higher score indicates better sexual functioning. Based on the equal weighting of the domains, the maximum score for each domain is 6 and for the entire scale is 36. A score of zero indicates that the individual has not had sexual activity for at least the past 4 weeks. The cutoff point for sexual dysfunction is 26.55 and has the highest sensitivity. A higher score indicates a higher level of sexual functioning. The validity and reliability of the FSFI questionnaire in Iranian culture has been previously evaluated by Heidari et al.
2
Description
Sexual Self-Care
Timepoint
before and one month after the intervention
Method of measurement
This questionnaire was designed by Yazdani et al., in 1401 with the aim of measuring self-reported sexual self-care in women of reproductive age. The final version of the sexual self-care questionnaire in women of reproductive age was designed with 40 items in 4 areas including: prevention of sexually transmitted diseases and genital infections, prevention of female cancers, prevention of unwanted pregnancy, and sexual promotion. The psychometric properties of this questionnaire showed that the overall validity index of the instrument was 93% and the overall validity ratio of the instrument was 96%. The relative reliability of the entire instrument was also shown by Cronbach's alpha of 94%. It has 40 questions and 4 subscales with the following questions: The first factor: prevention of sexually transmitted diseases and genital infections 14 questions: 1 to 14 The second factor: prevention of female cancers 7 questions: 15 to 21 The third factor: prevention of unwanted pregnancy 6 questions: 22 to 27 The fourth factor: promotion of sexual health 13 questions: 28 to 40 The subscale scores are interdependent and the questionnaire has a total score. The scoring of this questionnaire is based on a 5-point Likert scale, with the answer “never” being given a score of 1, “rarely” a score of 2, “sometimes” a score of 3, “often” a score of 4, and “always” a score of 5. Question numbers 25, 24, and 26 are also scored in reverse. In the first subscale, the lowest raw score is 14 and the highest raw score is 70. In the second subscale, the lowest raw score is 7 and the highest raw score is 35. In the third subscale, the lowest raw score is 6 and the highest raw score is 30. In the fourth subscale, the lowest raw score is 13 and the highest raw score is 65. The total score of the questionnaire is 200 and the minimum is 40. The higher the score, the greater the sexual self-care.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After completing the sexual health education course and the practical training course under the supervision of a supervisor and acquiring the necessary sexual health education skills, the researcher will implement the sessions according to the sexual counseling based on the Good Enough Sexual Experience (GES) model.The Good Enough Sexual Experience (GES) model was designed by Mathers and McCarthy in 2007 and its content is a realistic view of sexual value that includes two basic issues of mutual enjoyment of sex, intimacy and love in order to obtain the highest pleasure in people based on their ability and focuses on replacing classic sexual beliefs with expectations based on pleasure and flexible sexual activity. This model teaches that sexual problems may occur periodically in people's lives and that the level of sexual pleasure is not the same throughout life and that exaggerated expectations of ideal and perfect sex should be transformed into realistic expectations.This model includes 12 principles: 1- Explaining sex as a vital element of life 2- The importance of sex quality and sexual satisfaction in couples' sexual development 3- Setting realistic expectations of sex 4- Emphasis on physical health and healthy behavioral habits to restore sexual health 5- Behavioral education and counseling (mindfulness) 6- Equal attention to obtaining sexual pleasure and proper sexual performance 7- Counseling to overcome sexual fears and concerns and teaching flexible sexual experiences 8- Letting go of idealistic ideas about sex and setting goals in the relationship 9- Getting to know sexual arousal styles 10- Getting to know gender differences and accepting them 11- Strengthening communication skills 12- Teaching the cycle of sexual desire and counseling to personalize sexual desire which are mentioned in the section on the goals of the intervention sessions and the content of the sessions has also been compiled according to similar studies.It should be noted that the trained researcher will be supervised by the supervisor for one hour once a week for group sessions with clients and will be under his supervision and presence. The intervention will be held in groups of 6 people in 6 2-hour group sessions once a week.After the completion of each counseling and training session, the content file of the same session will be sent to the participant for repetition during the week. It is also emphasized that it should be made available to his wife as well.
Category
Behavior
2
Description
Control group: Individuals in this group will receive routine counseling from the center's staff. In order to comply with research ethics, at the end of the study, individuals in the control group will be referred to a sex clinic and provided with an educational package.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatima Al-Zahra Fertility and Infertility Center, Babol City
Full name of responsible person
hajar pasha
Street address
Ganjafroz street, Babol medical Sciences univercity
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶۴۷۷۴۵
Phone
+98 11 3219 9592
Email
dhajarpasha@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Ganj Afroz Street, Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶۴۷۷۴۵
Phone
+98 11 3219 9592
Fax
+98 11 3219 0181
Email
info@mubabol.ac.i
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Hajar Pasha
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Babol University of Medical Sciences, Ganj Afrooz Ave., Babol, Iran.
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶۴۷۷۴۵
Phone
+98 11 3219 9592
Fax
+98 11 3219 0181
Email
dhajarpasha@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Hajar Pasha
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Babol University of Medical Sciences, Ganj Afrooz Ave., Babol, Iran.
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶۴۷۷۴۵
Phone
+98 11 3219 9592
Fax
+98 11 3219 0181
Email
dhajarpasha@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Yasamin Nami
Position
Master's student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Babol University of Medical Sciences, Ganj Afrooz Ave., Babol, Iran.
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶۴۷۷۴۵
Phone
+98 11 3219 9592
Email
21yasamin11nami@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the confidentiality of the research topic, which is related to the sexual issues of infertile women, it is not possible to provide individual data of the participants.