: The Co-effect of sensate focus technique and pelvic floor muscle exercises education on sexual quality of life and sexual function in primiparous women after vaginal delivery
The aim of this study is valuating the CO- effect of sensate focus technique and pelvic floor muscle exercises education on sexual quality of life and sexual function in primiparous women after vaginal delivery.
Design
This study will be a Phase III of clinical trial. The subjects will be simple randomly assigned into two groups Control and intervention with 41 participants.
Settings and conduct
In the practical training of pelvic floor exercises, the researcher, after evaluating the vaginal pelvic floor strength, will ask the participants to constrict the pelvic floor muscles on the researcher's fingers and based on the dynamic bearing of the pelvic floor muscle and the time of fatigue They have been train for a 5-10 second contraction followed by a 3 second rest period, . sensate focus exercises are also taught in lectures, along with educational slides and related images. The health center of Baharestan, under the supervision of the Iran University of Medical Sciences
Participants/Inclusion and exclusion criteria
Primiparous women with normal delivery at reproductive age which starting sexual intercourse after delivery
Intervention groups
In the intervention group, a face-to-face training session is conducted by the researcher in the form of lectures and practical training of pelvic floor exercises and speech training, along with the presentation of slides and educational images of the technique of sensory concentration in the presence of the spouse will be done.
Main outcome variables
Sensate focus technique; Pelvic floor muscle exercises; Sexual quality of life; Sexual function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181218042041N1
Registration date:2019-02-22, 1397/12/03
Registration timing:registered_while_recruiting
Last update:2019-02-22, 1397/12/03
Update count:0
Registration date
2019-02-22, 1397/12/03
Registrant information
Name
Elham Hamdollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5632 5542
Email address
mehrasa168@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
: The Co-effect of sensate focus technique and pelvic floor muscle exercises education on sexual quality of life and sexual function in primiparous women after vaginal delivery
Public title
sensate focus technique and pelvic floor muscle exercises education on sexual quality of life and sexual function
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Primiparous women with normal delivery at reproductive age
Starting sexual intercourse after delivery
Not having a known disease
The absence of complications (diseases, bleeding, abortion) during pregnancy and delivery
Not having mental illness
monogamous husband and living with his wife now and during the study
ability to Read and Write Persian Language
in the 8-10 weeks after vaginal delivery
Being Iranian and living in Tehran
Having a healthy infant
Having exclusive Breastfeeding
couples without addiction to drugs and alcohol
infants who had not been hospitalized at the time of the study
Non-use of drugs that affect sexual function
Non-stressed during the past month
The absence of uterine prolapse and cystocell and rectus grade 3 and 4
Not having urinary tract infection
Not having history of pelvic surgery (coloporphy, restoration)
The absence of active lesions or lesion in the genital area that interferes with sex (penetration).
Not having a history of infertility
Not having a hard labor (vacuum, lengthy stretch)
Exclusion criteria:
Unwillingness to stay in the study
Getting pregnant while studying
Failure to do regular exercise training
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
41
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done simply.
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 Tarbiat Modares University of Medical Sciences
Street address
NO.4Milane 4 West Arghavan Ave.golestan Baharestan City Saveh Road
City
Tehran
Province
Tehran
Postal code
3759118378
Approval date
2019-01-01, 1397/10/11
Ethics committee reference number
IR.MODARES.REC.1397.166
Health conditions studied
1
Description of health condition studied
sexual dysfunction
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction not due to a substance or known physiological condition
Primary outcomes
1
Description
Improving sexual function
Timepoint
One month and then two months later
Method of measurement
questionnaire of female sexual function index (FSFI)
Secondary outcomes
1
Description
Improving sexual quality of life(SQOL-F)
Timepoint
One month and then two months later
Method of measurement
The questionnaire sexual quality of life -female( SQOL-F)
Intervention groups
1
Description
Intervention group: A face-to-face teaching session is provided by the researcher in the form of lectures and practical training of pelvic floor exercises and speech training, along with presentation of slides and Educational pictures educational for sensate focus technique in the presence of the spouse. This two-hour training will be held in classes with 3-5 couples
Category
Behavior
2
Description
Control group: There will be no intervention in the control group and at the end of the intervention period, the training will be provided to the control group