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Comparison of effect of two interventional methods including of kegel excersice and sexual education on sexual function in postmenopausal women

Protocol summary

Summary
This study will be a randomized clinical trial. A total of 150 women, aged 40 to 60 years, who have reached menopause no longer than 3 years prior to the study, and are willing to cooperate, will participate in the study. After giving informed consent, the subjects will complete the Female Sexual Function Index (FSFI) questionnaire, the World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire, the Menopause Rating Scale (MRS), and a researcher-made questionnaire about personal and marital relationship. Blood samples will, also, be taken to check the sex hormones (total testosterone, DHEAS, SHBG, and estradiol) of the subjects. To encourage the subjects to participate, their blood sugar, triglycerides, total cholesterol, LDL, and HDL, will be measured. The subjects, then, will be randomly divided into three groups of 50 members: a group performing Kegel exercises (intervention group), a group being trained on sex issues related to menopause (intervention group), and a group being trained on general issues related to menopause (control group). These three groups will participate in their respective training sessions. Apart from receiving the necessary trainings, the subjects will be given educational booklets. The members of the group performing Kegel exercises will receive a daily exercise checklist. The intervention groups will be monitored weekly by phone calls. After 12 weeks, all participants will complete the questionnaires again and blood samples will be taken from them for hormone testing. The data acquired before and after the intervention in the three groups will be analyzed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014120320201N1
Registration date: 2015-01-26, 1393/11/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-01-26, 1393/11/06
Registrant information
Name
Soheila Nazarpour
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8865 5366
Email address
soheilanazarpour@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2014-12-14, 1393/09/23
Expected recruitment end date
2015-04-09, 1394/01/20
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
Comparison of effect of two interventional methods including of kegel excersice and sexual education on sexual function in postmenopausal women
Public title
Comparison of effect of pelvic floor exercise and sex education on sexual function in postmenopausal women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Natural menopause (neither surgical nor premature menopause); age 40-60, not having been more than 3 years since the onset of menopause; lack of acute heart diseases; lack of any serious mental illness; absence of severe psychological stress such as an accident or loss of a family member in the past 3 months; having sexual intercourse with husband; the absence of sexual dysfunction in husband; not using herbal medicines containing phytoestrogens or supplements of sexual hormones in any form; not having a drug abuser spouse; having the willingness to participate in interventions to improve sexual function Exclusion criteria: Being unwilling to cooperate in the ongoing investigation; having debilitating diseases (such as cancer) which prevent the person from participating in interventions; having a surgery during the intervention; having marital discord, divorce, death or illness of spouse during the intervention
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: 150
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

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical
Street address
Velenjak St. , Shahid Chamran Highway, Tehran, Iran
City
Tehran
Postal code
Approval date
2015-01-13, 1393/10/23
Ethics committee reference number
4ERCIES93/10/23

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
Rate of sexual function
Timepoint
Before Intervention, 3 months after intervention
Method of measurement
Female Sexual Function Index (FSFI) questionnaire

2

Description
Life Quality
Timepoint
Before Intervention, 3 months after intervention
Method of measurement
WHO Quality of Life-BREF (WHOQOL-BREF) questionnaire

3

Description
severity of menopausal symptoms
Timepoint
Before Intervention, 3 months after intervention
Method of measurement
Menopause Rating Scale (MRS) questionnaire

4

Description
Total Testosterone
Timepoint
Before Intervention, 3 months after intervention
Method of measurement
Enzyme immunoasay (EIA)

5

Description
Dehydroepiandrosterone Sulfate (DHEAS)
Timepoint
Before Intervention, 3 months after intervention
Method of measurement
Enzyme immunoasay (EIA)

6

Description
SHBG
Timepoint
Before Intervention, 3 months after intervention
Method of measurement
Enzymo-immunometric assay (EIMA)

7

Description
EStradiol
Timepoint
Before Intervention, 3 months after intervention
Method of measurement
Enzyme-Linked Fluorescent Immunoassay (FLFA)

Secondary outcomes

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Intervention groups

1

Description
Intervention 1: Education on sex issues and how to deal with problems of sexual dysfunction including disorders in desire, arousal, orgasm, and pain; and education using PowerPoint presentation and speech in groups of 10-15 members in a session; and delivery of training booklets and weekly follow-ups for three months.
Category
Behavior

2

Description
Intervention 2: Pelvic floor muscles training (Kegel exercises) by PowerPoint presentations and videos in groups of 10-15 members in a session; and delivery of training booklets, checklists of daily exercise, and weekly follow-ups for regular exercise for three months.
Category
Behavior

3

Description
Control: Education on general issues related to menopause such as complaints, nutrition, etc. by PowerPoint presentations and speech in groups of 10-15 members in a session; and delivery of training booklets.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University, Chaloos Branch
Full name of responsible person
Soheila Nazarpour
Street address
City
17 Shahrivar street, Opposite the mosque of Imam Hussain (AS), Islamic Azad University, Chaloos Br

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Masome Simbar (Vice chancellor for research of Nursing and Midwifery Department), Fahimeh Ramezani T
Street address
Velenjak Street , Shahid Chamran Highway, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences, Midwifery and Nursing Department
Full name of responsible person
Soheila Nazarpour
Position
PhD student in the field of Reproductive Health
Other areas of specialty/work
Street address
School of Nursing and Midwifery,Niayesh st., Vali Asr Ave.,Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8865 5366
Fax
Email
soheilanazarpour@sbmu.ac.irsoheilanazrpour@yahoo.comsn_9547@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences, Midwifery and Nursing Department
Full name of responsible person
Masome Simbar
Position
Ph.D in the field of Reproductive Health
Other areas of specialty/work
Street address
School of Nursing and Midwifery,Niayesh st., Vali Asr Ave.,Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8865 5366
Fax
Email
msimbar@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences, Midwifery and Nursing Department
Full name of responsible person
Soheila Nazarpour
Position
PhD student in the field of Reproductive Health
Other areas of specialty/work
Street address
School of Nursing and Midwifery,Niayesh st., Vali Asr Ave.,Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8865 5366
Fax
Email
soheilanazarpour@sbmu.ac.irsoheilanazarpour@yahoo.comsn_9547@yahoo.com
Web page address

Sharing plan

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