Protocol summary

Summary
The present study is a clinical trial to compare the effect of two methods of group and peer education on sexual dysfunction in menopausal women. Participants include 108 menopausal women that would randomly be allocated into three groups of peer education, group education and control (each containing 36 women). Inclusion criteria: being a menopausal woman with sexual dysfunction and having a husband, being younger than 65 years, not having a history of surgery for the participants and their husbands, not having any sexual diseases and other diagnosed diseases that affect sexual function, not consuming drugs that affect sexual function, and not being addicted to alcohol, cigarettes and opioids for the participants and their husbands. The exclusion criteria: occurrence of mental or physical problems, receiving information about sexual function from any source during the study, not fully participating in conducted sessions and having interrupted sexual activity at the time of the study. In the peer education group, first 8 participants would be selected as the peers; after receiving education from the researcher, 4 of them would selected each would educate a group of 9 during two 2-hour sessions. In the group education group, the researcher would provide the education during two 2-hour sessions for 4 groups of 9. The control group would receive no intervention. The educational content for both groups would be similar. Information would be collected from all groups before and one month after the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016102926756N3
Registration date: 2017-11-19, 1396/08/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-11-19, 1396/08/28
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
Isfahan University of Medical Sciences
Expected recruitment start date
2016-10-26, 1395/08/05
Expected recruitment end date
2017-04-25, 1396/02/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of two methods of group and peer education on sexual dysfunction in menopausal women
Public title
Comparing the effect of two methods of group and peer education on sexual dysfunction in menopausal women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: being a menopausal woman with sexual dysfunction and having a husband and gaining a score of less than 28 from the Female Sexual Function Index (FSFI); being younger than 65 years; not having a history of surgical procedures for the participants and their husbands such as prostatectomy, hysterectomy, oophorectomy, mastectomy and other breast surgeries; having physical and mental health based on the participants’ statements and their medical files; not having premature menopause; having an educational level of elementary school or higher; being of Iranian nationality for the couples; not having any diagnosed sexual problems that could influence sexual function such as premature ejaculation and impotence; not living separately from the husband at the time of the study; not having any diagnosed diseases for the participants and their husbands that could affect sexual function such as cancers, mood disorders (depression and anxiety), vasculitis, thyroid disorders, adrenal glands (cortex part) diseases, diabetes, high blood pressure, cardiovascular, pulmonary, liver and renal diseases, central nervous system disorders, infectious and sexually transmitted diseases; not consuming drugs for the participants and their husbands that would affect sexual function including psychotropic drugs, H2 receptor blockers, cardiovascular and antihypertensive drugs, anticonvulsants, opiates, anticholinergic and antihistamines, anticancer drugs, hypnotics and hormonal drugs; not being remarried during the menopause period; not being addicted to alcohol, cigarettes and opioids for the participants and their husbands; not having participated in educational classes about menopause with focus on sexual education; not being a physician, dentist, paramedic and psychologists. Exclusion criteria: occurrence of mental or physical problems for the participants during the study; receiving any information about sexual function from any source during the study; unwillingness to continue the study; not fully participating in the conducted sessions for both groups; having interrupted sexual activity at the time of the study.
Age
From 40 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 108
Randomization (investigator's opinion)
Randomized
Randomization description
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
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Thousand Acres street, Azadi square, Isfahan, Iran.
City
Isfahan
Postal code
Approval date
2016-09-26, 1395/07/05
Ethics committee reference number
IR. MUI. REC. 1395.3.543

Health conditions studied

1

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

Primary outcomes

1

Description
Women sexual dysfunction
Timepoint
Before the intervention, one month after the intervention
Method of measurement
FSFI Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Education through peer menopausal women: conducting two educational sessions (with a one-week interval) by a peer participant for 4 groups of 9 menopausal women with sexual dysfunction
Category
Lifestyle

2

Description
Group education: conducting two educational sessions by the researcher (for 4 groups of 9) with a one-week interval
Category
Lifestyle

3

Description
Control group: receiving no educational intervention and only the routine cares
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Community health centers of Isfahan city
Full name of responsible person
Dr Reza Khadivi
Street address
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Mehdi Nematbakhsh
Street address
Vice-chancellor for Research, Isfahan University of Medical Sciences, St. thousand acres, Azadi Square, Isfahan,Iran.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Mahnaz Noroozi
Position
Ph.D in Reproductive Health
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Isfahan University of Medical Sciences, Thousand Acres street, Azadi square, Isfahan, Iran.
City
Isfahan
Postal code
Phone
+98 31 3792 7546
Fax
Email
noroozi@nm.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Mahnaz Noroozi
Position
Ph.D in Reproductive Health
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Isfahan University of Medical Sciences, Thousand Acres street, Azadi square, Isfahan, Iran.
City
Isfahan
Postal code
Phone
+98 31 3792 2946
Fax
Email
noroozi@nm.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Zahra Vakili
Position
BS in Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Isfahan University of Medical Sciences, Thousand Acres street, Azadi square, Isfahan, Iran.
City
Isfahan
Postal code
8138996715
Phone
+98 31 3441 1421
Fax
+98 31 3669 9398
Email
vakiliz@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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