Protocol summary

Study aim
Determining the effect of sexual life reframing intervention program on improving sexual function in postmenopausal women
Design
The controlled clinical trial study will be conducted on 44 postmenopausal women. Six comprehensive health service centers will be clustered and selected through non-random quota sampling. Three centers will be randomly chosen for the intervention group, and the remaining three will serve as the control group. Postmenopausal women will be selected via convenience sampling at the chosen centers.
Settings and conduct
This study will be conducted in selected urban health service centers affiliated with Isfahan University of Medical Sciences. The educational program will address the physical, psychological, and relational aspects of sexual life, alongside the influence of social and cultural norms on women's perceptions of sexuality during menopause. The program's effectiveness will be assessed by comparing the results of the Women's Sexual Function Index Questionnaire before and after the intervention.
Participants/Inclusion and exclusion criteria
At least 12 months have passed since the onset of menopause The age range between 40 and 60 years Being married and living stably with a husband Not having any diseases affects sexual function Not using medications that affect sexual function A score below 28 on the standard Female Sexual Function Index questionnaire
Intervention groups
The intervention group will participate in the educational program through five weekly sessions of 90 minutes each, while the control group will receive their usual care at respective centers. At the end of the study, an educational booklet on improving sexual function will be provided to the control group to ensure ethical compliance.
Main outcome variables
Improving sexual function in postmenopausal women

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160224026756N8
Registration date: 2025-01-21, 1403/11/02
Registration timing: prospective

Last update: 2025-01-21, 1403/11/02
Update count: 0
Registration date
2025-01-21, 1403/11/02
Registrant information
Name
Mahnaz Noroozi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3441 1421
Email address
noroozi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-01-24, 1403/11/05
Expected recruitment end date
2025-06-21, 1404/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of sexual life re-framing interventional program on improving sexual function in postmenopausal women
Public title
The Effect of sexual life re-framing interventional program on improving sexual function in postmenopausal women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having Iranian nationality for couples Consent to participate in the study Natural menopause At least 12 months have passed since the onset of menopause The age range between 40 and 60 years Having primary and higher education Being married and living stably with a husband At least 1 year has passed since the permanent marriage and the woman is the only wife of her husband Score below 28 on the standard Female Sexual Function Index (FSFI) questionnaire
Exclusion criteria:
A history of diagnosed major psychological problems undergoing drug treatments A history of drug and alcohol abuse in both wife and husband Premature ejaculation or impotence in husband according to the self-reports Prior participation in sex education classes A history of surgery in the participants and their husbands, such as prostatectomy, hysterectomy, oophorectomy, mastectomy, and other breast surgeries Unpleasant events during the last 6 months, such as the death of parents, etc. Any chronic diseases affects sexual function in the participants and their husbands (including systemic diseases such as liver, kidney, and lung failure), cardiovascular diseases, malignant diseases, psychological diseases, mood disorders (depression, anxiety), ulcerative colitis, vasculitis, thyroid and adrenal cortex diseases, diabetes, high blood pressure, central nervous system disorders, infectious, and sexually transmitted diseases Using the most common groups of medications that affect sexual function in the participants and their husbands
Age
From 40 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the selection of comprehensive health service centers will be clustered and then conducted on a quota basis using non-random methods. In this regard, among the comprehensive health service centers covered by city health center 1 and 2, six centers with appropriate population statistics (three from each city health center) will be selected. Then, among these six centers, three will be randomly selected for the intervention group, and three will be chosen for the control group. Postmenopausal women will be selected using a convenient sampling method at the chosen centers.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Participants will be randomly assigned to two intervention groups (receiving the training program) and control groups (not receiving the intervention).

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Nursing, Rehabilitation and Management schools - Isfahan University of
Street address
Isfahan University of Medical Sciences, Faculty of Nursing and Midwifery
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-02-25, 1401/12/06
Ethics committee reference number
IR.MUI.NUREMA.REC.1401.165

Health conditions studied

1

Description of health condition studied
Sexual function of postmenopausal women
ICD-10 code
F52
ICD-10 code description
Other sexual dysfunction, not caused by organic disorder or disease

Primary outcomes

1

Description
Sexual function of postmenopausal women
Timepoint
At the beginning of the study (before the intervention) and one month after the program ended.
Method of measurement
Female Sexual Function Index Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this study, participants in the intervention group will participate in an educational program consisting of five 90-minute sessions, held weekly in small groups of 7 to 8 individuals. The program's content has been carefully developed to address the physical, psychological, and relationship aspects of sexual life, as well as the influence of social and cultural norms on women's perceptions of sexuality during menopause. The educational sessions will take place in a private room within the research environment and utilize various teaching methods, including lectures, question-and-answer , group discussions, counseling, role-playing, and the use of photos, slides, and educational booklets. The first few minutes of each session will be dedicated to reviewing background information, assessing participants' awareness, sharing experiences, and addressing any questions or concerns related to the material raised in the previous session. At the end of each session, participants will have the opportunity to ask any questions. If individuals are hesitant to express their opinions or share their issues in front of the group, these concerns can be discussed privately after the session. Additionally, participants in the intervention group will have access to free individual telephone counseling sessions to address private questions and concerns, which will also help enhance their overall cooperation and engagement.
Category
Lifestyle

2

Description
Control group: Control group participants will receive routine care at the relevant centers.To comply with ethical considerations, an educational booklet on improving sexual function will be provided to the subjects in the control group at the end of the study.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Comprehensive Health Service Centers affiliated with Isfahan University of Medical Sciences
Full name of responsible person
Mahnaz Noroozi
Street address
Isfahan University of Medical Sciences, Faculty of Nursing and Midwifery
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7570
Email
noroozi@nm.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Isfahan University of Medical Sciences, Faculty of Nursing and Midwifery
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7570
Email
noroozi@nm.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mahnaz Noroozi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Isfahan University of Medical Sciences, Faculty of Nursing and Midwifery
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7570
Email
noroozi@nm.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahnaz Noroozi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Isfahan University of Medical Sciences, Faculty of Nursing and Midwifery
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7570
Email
noroozi@nm.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahnaz Noroozi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Isfahan University of Medical Sciences, Faculty of Nursing and Midwifery
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7570
Email
noroozi@nm.mui.ac.ir

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
Loading...