To determine and compare the effect of Kegel exercise and lubricant gel on sexual function in menopausal women
Design
The present study is a clinical trial with a control group and parallel groups.The allocation of individuals to each of the three groups is based on a random number table.
Settings and conduct
Postmenopausal women who recruited to health care centers of Dezful and wish to participate in the study will be randomly assigned to one of three study groups if they meet the inclusion criteria. Participants first fill in the DAAS questionnaire to examine psychological criteria and then are examined by the researcher for evaluating their pelvic-floor muscle strength which will be scored based on the Oxford Grading Scale. Participants will enter the study if they achieve a score of 2 or higher and do not have depression, anxiety, and stress based on DAAS. Prior to the intervention, all groups will complete the Sexual Function Questionnaire. The first group will receive intervention based on the Kegel exercise and instruction on how to perform the exercises. The second group will receive lubricant gel and will be instructed on how to use it. No intervention will be for the control group. These interventions will be continued for 12 weeks, and sexual function will be re-evaluated three times, i.e. the end of the first, second, and third months.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Married postmenopausal women who are in their first ten years of menopause, who are not physically and mentally ill and do not use hormone or sexually affecting drugs.
Exclusion criteria:
Unwillingness to participate in the study and sensitivity and allergy to lubricant gel in the intervention group with gel.
Intervention groups
Fifty women are assigned to the Kegel exercise group, 50 to lubricant gel group
Main outcome variables
Sexual function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150128020854N7
Registration date:2019-09-30, 1398/07/08
Registration timing:registered_while_recruiting
Last update:2019-09-30, 1398/07/08
Update count:0
Registration date
2019-09-30, 1398/07/08
Registrant information
Name
Hedyeh Riazi
Name of organization / entity
Shahid Beheshti University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 912 386 5612
Email address
h.riazi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-10-22, 1398/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of kegel exercise and lubricant gel on the sexual function of menopausal women
Public title
Effect of kegel exercise and lubricant gel on the sexual function
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Physiologic menopause (not due to surgery or premature menopause before 40 years of age)
Being in the first 10 years of menopause
Lack of self-reported medical diseases affecting sexual function (respiratory and cardiovascular disease, arthritis, Parkinson's disease, or multiple sclerosis)
Lack of any self-reported psychological disease
Absence of depression, anxiety, or stress based on the Depression Anxiety Stress Scales (DAAS)
Scoring 2 or higher on the Oxford Grading Scale (OGS) for pelvic-floor muscle strength
having sexual function
Absence of impotence in the spouse (as declared by the participant)
Not taking any herbal medicine containing phytoestrogen or any form of hormone replacement therapy
Not taking any medicine affecting sexual function
Negative history of hysterectomy and mastectomy
Maximum five vaginal delivery
Lack of self-reported genital infections
Using lubricant gel in all the sexual intercourses in lubricant gel intervention group)
Exclusion criteria:
Unwillingness to cooperating in the study.
Allergy to lubricant gel.
Age
No age limit
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
From the 7 health care centers in Dezful city, five centers will be randomly selected. Then postmenopausal women covered by these centers will be contacted and invited to participate in the study. Eligible women will be divided into three groups of 50 based on the random number table. In this way, all participants will be given three-digit codes from 001 to 150. Then, using the website www.Randomization.com, the statistical consultant will provide three sets of codes for researcher, the first in the intervention group with kegel, the second in the intervention group with lubricant gel, and the third in the control group.
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
Shahid Beheshti Univercity of Medical Sciences, School of Nursing and Midwifery
Street address
Vali Asr Ave, Niayesh Cross Road, SBMU School of Nursing & Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2017-07-18, 1396/04/27
Ethics committee reference number
IR.SBMU.PHMN.1396.777
Health conditions studied
1
Description of health condition studied
sexual function
ICD-10 code
F52.9
ICD-10 code description
Unspecified sexual dysfunction not due to a substance or known physiological condition
Primary outcomes
1
Description
Sexual function
Timepoint
Before intervention, one, two and three months after intervention
Method of measurement
ّFemale Sexual function questionnaire (FSFI)
Secondary outcomes
empty
Intervention groups
1
Description
In the Kegel intervention group, in a 60-minute session, a brief introduction to the anatomy and function of the pelvic floor muscles, an introduction to how the Kegel exercise is performed, its mechanism and function, its benefits, and finally an evaluation of participants to ensure that the exercise is performed properly will be done. PowerPoint, replica pelvis and movies will be used through individually and face-to-face teaching. A daily checklist (three times daily in the morning, noon, night) for 12 weeks as well as a Kegel Exercise Training Guide will be given to the participants as a pamphlet and then weekly follow up by telephone is performed.
Category
Behavior
2
Description
In the intervention group with lubricant gel 45 minutes training session will be held for familiarizing with pelvic anatomy, pelvic floor muscles, vaginal and genitalia changes in menopause, lubricant gel and its benefits and how to use it is performed and finally evaluation of participants for learning materials will be done. Participants will be asked to record the frequency of using lubricant gel in their checklists for 12 weeks and will be followed up weekly by phone for investigation any reaction and side effects of lubricant gel and possible questions.
Category
Behavior
3
Description
Control group: The control group will not receive any intervention and will solely receive general menopausal care. Demographic questionnaire and sexual function questionnaire will be completed with 12 weeks interval.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat-e Roghayeh healthcare center
Full name of responsible person
Atefeh khosravi
Street address
Valiasr blv
City
Dezful
Province
Khouzestan
Postal code
6461834456
Phone
+98 61 4255 2917
Email
atefeh.khosravi120@gmail.com
2
Recruitment center
Name of recruitment center
Gholami healthcare center
Full name of responsible person
Atefeh Khosravi
Street address
Shariati St.
City
Dezful
Province
Khouzestan
Postal code
6461892345
Phone
+98 61 4253 2580
Email
atefeh.khosravi120@gmail.com
3
Recruitment center
Name of recruitment center
No. 1 healthcare center
Full name of responsible person
Atefeh Khosravi
Street address
Enghelab St.
City
Dezful
Province
Khouzestan
Postal code
6461767542
Phone
+98 61 4222 2402
Email
atefeh.khosravi120@gmail.com
4
Recruitment center
Name of recruitment center
No. 5 healthcare center
Full name of responsible person
Atefeh Khosravi
Street address
Shahid Beheshti St.
City
Dezful
Province
Khouzestan
Postal code
6461932749
Phone
+98 61 4224 0301
Email
atefeh.khosravi120@gmail.com
5
Recruitment center
Name of recruitment center
Kooy-e Azadegan healthcare center
Full name of responsible person
Atefeh Khosravi
Street address
Mobarez blv. , Azadegan
City
Dezful
Province
Khouzestan
Postal code
6461612478
Phone
+98 61 4222 0013
Email
atefeh.khosravi120@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahrokh Dolatian
Street address
Valiasr Ave. cross of Niyayesh
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5363
Email
sbnmf@sbmu.ac.ir
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
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Atefeh Khosravi
Position
Msc student of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Reproductive Health
Street address
Vali-Asr cross of Niyayesh
City
Tehran
Province
Khouzestan
Postal code
198571443
Phone
+98 61 3632 3587
Email
atefeh.khosravi120@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hedyeh Riazi
Position
Ph.D. in reproductive health\ Academic member of the midwifery and reproductive health department
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of nursing and midwifery, Valiasr ave.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
h.riazi@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Atefeh Khosravi
Position
Msc student of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Reproductive Health
Street address
School of nursing and midwifery, valiasr ave.
City
Tehran
Province
Tehran
Postal code
6455134853
Phone
+98 61 3632 3587
Email
atefeh.khosravi120@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
All the data will be published in tables in the final paper.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not 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
--
When the data will become available and for how long
--
To whom data/document is available
--
Under which criteria data/document could be used
--
From where data/document is obtainable
--
What processes are involved for a request to access data/document