(1) Objectives : The effect of pelvic floor muscle exercise on sexual function and satisfaction in primiparus women.(2) Design:This study is a clinical trial is designed as a before and after.(3) Setting and conduct: A population of 100 women who refer to Gynecology Clinic will be investigated in this clinical trial after being informed and signing the written consent . the questionnaires were asked by the researcher and will be completed. Subjects passing the history will be blindly divided in two groups: intervention and control. Then we asked from intervention group doing kegel exercise .Each exercise must be tenth contraction 1-3 seconds followed by 3 seconds rest done and over, the individual based on his ability and the number and duration of contractions gradually increase to a rate of 5 s contraction and 5 seconds, release and reach 90 to 100 contractions per day. Do this exercise for 16 weeks will be conducted by the research unit .with regard to sex are explained for each training session will be held 16 weeks after the sexual satisfaction and sexual performance study based on questionnaires mentioned above shall be determined Shadow of results before and after the intervention group and in the same period When compared with the control group, (4) Participants including major eligibility criteria: Inclusion criteria: All units are Iranian; Couples living together have at least the past 1 year married ; Couples are not addicted to drugs and alcohol; their marriage is not compulsory; During the last 3 months of emotional stress (such as the death of first-degree relatives) are not; Couples do not have a mental or physical illness ; All women are nulliparous ; They were to be delivered vaginally. Exclusion criteria : Lack of exercise at least once a day.(5) Intervention: we asked from intervention group doing kegel exercise .Each exercise must be tenth contraction 1-3 seconds followed by 3 seconds rest done and over, the individual based on his ability and the number and duration of contractions gradually increase to a rate of 5 s contraction and 5 seconds, release and reach 90 to 100 contractions per day, (6) main outcome measures (variables):sexual function and sexual satisfaction.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106156284N3
Registration date:2012-02-26, 1390/12/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-02-26, 1390/12/07
Registrant information
Name
Maryam Modarres
Name of organization / entity
Tehran university of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6656 8142
Email address
modarres@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical sciences
Expected recruitment start date
2011-01-21, 1389/11/01
Expected recruitment end date
2011-09-21, 1390/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pelvic floor muscle exercise on sexual function and satisfaction in primiparus women.
Public title
The effect of pelvic floor muscle exercise on sexual function and satisfaction in primiparus women.
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: All units are Iranian; Couples living together have at least the past 1 year married ; Couples are not addicted to drugs and alcohol; their marriage is not compulsory; During the last 3 months of emotional stress (such as the death of first-degree relatives) are not; Couples do not have a mental or physical illness ; All women are nulliparous ; They were to be delivered vaginally. Exclusion criteria : Lack of exercise at least once a day.
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Ethics committee of Tehran University of Medical sciences
Street address
f 6th, Center organization of university, edge of Qods avenue, Keshavarz blvd
City
Tehran.
Postal code
Approval date
2011-06-26, 1390/04/05
Ethics committee reference number
1346/130/د
Health conditions studied
1
Description of health condition studied
Female genital prolapsed
ICD-10 code
N81
ICD-10 code description
Female genital prolapsed
Primary outcomes
1
Description
sexual function
Timepoint
Before the intervention and after 4 months
Method of measurement
Standard questionnaire (FSFI)
Secondary outcomes
empty
Intervention groups
1
Description
we asked from intervention group doing kegel exercise .Each exercise must be tenth contraction 1-3 seconds followed by 3 seconds rest done and over, the individual based on his ability and the number and duration of contractions gradually increase to a rate of 5 s contraction and 5 seconds, release and reach 90 to 100 contractions per day.
Category
Rehabilitation
2
Description
For the control group not given any training in pelvic exercises.only A brief description is given in relation to the sex. And a educational sessions are held.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Meysam
Full name of responsible person
Ellahe Booriaey
Street address
On your right hand, Ghapun alley,Ghazvin av , Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical sciences
Full name of responsible person
Research assistant of Tehran University of Medical sciences (Dr. Akbar Fotoohi)
Street address
5th floor,Central building of Tehran University of Medical sciences, edge of Qods Av, Keshavarz blvd, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran 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
Tehran University of Medical sciences
Full name of responsible person
Dr. Masud Yunesian
Position
Research Affairs
Other areas of specialty/work
Street address
601th Unit, 6th floor, Central Organization of Tehran University of Medical sciences, Qods ave, Keshavarz Blvd
City
Tehran
Postal code
Phone
+98 21 8163 3619
Fax
Email
younesian@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing & Midwifery
Full name of responsible person
Maryam Modarres
Position
MSc Midwifery
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, Tohid square
City
Tehran
Postal code
Phone
+98 912 388 0257
Fax
Email
modarres@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing & Midwifery of Tehran University
Full name of responsible person
Ellahe Booriaey
Position
College student
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, Tohid square
City
Tehran
Postal code
Phone
+98 21 6515 4060
Fax
Email
ellahebooriaey@ymail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)