Protocol summary

Summary
Objectives: Survey effect of pelvic floor muscle exercise on sexual self-efficacy and sexual quality of life, in nulliparous women after childbirth Design: This study is a clinical trial is designed as a before and after. method: this study perform on 104 women refer to selected health centers of Mashhad after obtaining informed consent . sampling will be done as two-stage (class - cluster) and women Be selected who are eligible and at 8 weeks after childbirth. and place in two groups(control- intervention) randomly. After examination including height, weight, BMI and pelvic examination is completed questionnaires by the researcher. Both groups received routine postpartum care training in the face to face for 30 minutes. In addition, the intervention group received a 30 minute face to face training about Kegel exercises. And from them are asked to do these exercises twice daily, and 20 to 15 times per shift their pelvic floor muscles contracted for 10 seconds and to relax for 10 seconds. This exercise should be repeated 20 times (5 min). After 2 minutes of rest, repeat the exercise for 3 times of 5 minutes. The participants will be required in the absence of muscle fatigue Increase the number of exercise to 35 times. Also a Booklet and a training audio CD will be given to the intervention group about Kegel exercises and pelvic floor muscles . Then will be given them the check list recorded of daily exercises . The researcher checks by phone participation of Kegel exercises and other problems. The samples will be asked to return 4 and 8 weeks later to evaluate the problems and Correct method exercises and again will be assessed sexual self efficacy, sexual quality of life at 12 weeks and 16 weeks. Inclusion criteria: Primiparous, vaginal delivery,at 8 weeks after childbirth,healthy singleton infant. Exclusion criteria: Couples addiction drug and alcohol, Couple with a spiritual and medical disease, Postpartum complications, be a professional athlete.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013062313750N1
Registration date: 2013-07-05, 1392/04/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-07-05, 1392/04/14
Registrant information
Name
Zahra Zare
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 915 871 0529
Email address
zarez901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy Mashhad University of Medical Sciences
Expected recruitment start date
2013-07-01, 1392/04/10
Expected recruitment end date
2013-12-01, 1392/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The survey effect of pelvic floor muscle exercises on sexual self-efficacy and sexual quality ofl life in nulliparous women after childbirth
Public title
The survey effect of pelvic floor muscle exercises on sexual self-efficacy and sexual quality ofl life in nulliparous women after childbirth
Purpose
Health service research
Inclusion/Exclusion criteria
inclusion criteria: being resident of Mashhad and Iran; be nulliparous and 8 weeks passed of delivery; be vaginal delivery; have a healthy baby; be married and she is only spouse; currently lives with her husband; sex be resumed after delivery and BMI be between 30-20. Exclusion criteria: couples addiction drug and alcohol; couple with a spiritual and medical disease; postpartum complications; be a professional athlete; stressful events occurred during the last month for couples; history of pelvic surgery or irradiation in the reproductive system; uterine prolapse or cystocele or rectocele grade 3 and 4; perineal signs of infection; inflammation; erythema and severe discharge. Exclusion criteria during the study: continues to be a reluctance to participate in research; become pregnant during the study; have not intercourse; regular exercise during the study; exercises have not done regularly and correctly.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 104
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
Mashhad University of Medical Sciences
Street address
Mashhad
City
Mashhad
Postal code
Approval date
2013-06-08, 1392/03/18
Ethics committee reference number
911064

Health conditions studied

1

Description of health condition studied
Pelvic organ prolapse in women
ICD-10 code
N81
ICD-10 code description
Female genital prolapsed

Primary outcomes

1

Description
sexual self efficacy
Timepoint
Before the intervention and 2 months after the intervention.
Method of measurement
SSES-F

2

Description
sexual quality of life
Timepoint
Before the intervention and 2 months after the intervention.
Method of measurement
SQOL-F

Secondary outcomes

1

Description
Marital satisfaction
Timepoint
Before the intervention and 2 months after the intervention.
Method of measurement
Questionnaires

Intervention groups

1

Description
The intervention group will be asked their pelvic floor muscles contracted at home twice daily, each for about 20-15 minutes and 20-15 for 10 seconds and then 10 seconds to relax.The exercises is performed in different positions (supine, standing, semi-recumbent, sitting, quadruped). At the same time, participants are encouraged increase the number of exercises in the absence of muscle fatigue to 35 times per shift gradually.
Category
Rehabilitation

2

Description
The control group Training will be given routine postpartum care in the face to face for 30 minutes and Possible questions in this context to be answered.An educational pamphlet given to them on the care.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Emamat Center
Full name of responsible person
Zahra Zare
Street address
Mashhad. Boulevard Emamat - Emamat 28 First Ave Intersection
City
Mashhad

2

Recruitment center
Name of recruitment center
Ali Ebn Abitaleb Center
Full name of responsible person
Zahra Zare
Street address
Shohada Square, St. Shirazi
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Deputy Mashhad University of Medical Sciences
Full name of responsible person
Research Deputy Mashhad University of Medical Sciences(Mohammad Ramezani)
Street address
Mashhad. Ebn Sina Street, Building Qureshi
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Ramezani
Position
Research Assistant
Other areas of specialty/work
Street address
Mashhad. University Avenue - Qureshi Building - Third Floor - Room 307
City
Mashhad
Postal code
Phone
+98 51 1843 3363
Fax
Email
ramresearch@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Nursing Midwifery, Mashhad
Full name of responsible person
Nahid Golmakani
Position
MSc
Other areas of specialty/work
Street address
Mashhad, University Street, Ibn Sina Street, Faculty of Nursing and Midwifery
City
Mashhad
Postal code
9137913199
Phone
+98 51138591511
Fax
Email
nms.it@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Zare
Position
Student
Other areas of specialty/work
Street address
Faculty of Nursing Midwifery, Mashhad
City
Mashhad
Postal code
Phone
Fax
Email
zarez901@mums.ac.ir
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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