Objective: Determining the effect of training package on mental image of reproductive system appearance and sexual function. Design: The controlled randomized clinical trial. Method: It will be conducted in health centers of Qazvin. The qualified individuals will randomly be allocated to two groups of 62 persons with blocks of 4 and 6. One of the members of research team who is not involved in sample selection, will determine random allocation sequence using the computer program. The closed opaque envelopes will be scored respectively and used to hide the allocation. Inclusion criteria: The women who have not given birth (nullipara women) and the women with parity 1 and 2 with normal (natural) and cesarean childbirth, living with permanent husband (during recent four weeks). The exclusion criteria consists of the women with multiple sex partners and divorce record. Interventions: In the intervention group, three training sessions will be held every day for an hour. The contents of training sessions in the intervention group are as follows: the first session is about the anatomy and physiology of reproductive system along with the images of natural external organ of reproductive (genital) system, the second session about the familiarity with female sex hormones and sensitive sexual organs (clitoris, labia major and minor and vaginal entrance), the third session is about the causes of negative mental image of doing unnecessary surgery and the implications of unnecessary surgeries of genital system. In the control group, the training package will be given them after completing the questionnaire. The variables of main outcome: mental image and sexual function will be measured before intervention and four weeks after intervention
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201506148170N8
Registration date:2015-09-24, 1394/07/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-09-24, 1394/07/02
Registrant information
Name
Jamileh Malakouti
Name of organization / entity
Nursing Faculty
Country
Iran (Islamic Republic of)
Phone
+98 41 1477 2699
Email address
malakoutij@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
women's Reproductive Health Research Center
Expected recruitment start date
2015-09-06, 1394/06/15
Expected recruitment end date
2015-12-06, 1394/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of an educational package on genital self-image and sexual function in women: a randomized controlled trial
Public title
The impact of an educational package on genital self-image and sexual function in women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Having tendency to participate in the research, Iranian nationality, literacy level at the extent of elementary and above, the women who have not given birth (nullipara women) and the women with parity 1 and 2 with normal (natural) and cesarean childbirth, the age of 18-40 years, not having mental disease and mental obsession according to the patient’s statement and not using the psychotropic drugs, lack of reproductive system diseases (vaginitis, herpes, genital warts, scarring caused by surgery or trauma, burn) according to the individual’s statement, the first marriage and being monogamous couples, living with permanent husband (during recent four weeks), lack of pregnancy and breastfeeding , being sexually active ( having sex during recent four weeks based on sexual function questionnaire). Exclusion criteria: Not having tendency to continue the participation in the study, the women with multiple sex partners (prostitutes), divorce record, pelvic surgeries and the other genital organs surgeries, radiotherapy and chemotherapy
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
124
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 Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences Research & Technology, Golgasht Street
City
Tabriz
Postal code
Approval date
2015-06-13, 1394/03/23
Ethics committee reference number
tbzmed.rec.1394.253
Health conditions studied
1
Description of health condition studied
33: Management, directors and family health programs
ICD-10 code
Z41,Z41.1,
ICD-10 code description
Procedures for purposes other than remedying health state, Other plastic surgery for unacceptable cosmetic appearance, Counselling related to sexual attitude, behaviour and orientation, Sex counselling, unspecified
Primary outcomes
1
Description
Genital self-image
Timepoint
Before and four weeks after training
Method of measurement
Inventory image of genitalia
2
Description
Sexual Function
Timepoint
Before and four weeks after training
Method of measurement
Female Sexual Function Index questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the control group, after completing the mental image self-made questionnaire and the female sexual function questionnaire, they were asked to refer again in the fourth week. In the fourth week, the control group will also be given the training package, after completing the female sexual function index questionnaires and the questionnaire of women’s mental image of their reproductive (genital) system
Category
Prevention
2
Description
In the intervention group, three training sessions will be held every day for an hour. If the training time does not agree with the participants, the time and date of holding the class will be coordinated with them. Considering the sample size of 62 persons, the number of participants in each group will be between 10 persons in each training session for intervention group during three weeks. At the beginning of session, the participants will be given the training package. The contents of training sessions in the intervention group are as follows: the first session is about the anatomy and physiology of reproductive system along with the images of natural external organ of reproductive(genital) system, the second session about the familiarity with female sex hormones and sensitive sexual organs(clitoris, labia major and minor and vaginal entrance), the third session about the causes of negative mental image of doing unnecessary surgery and the implications of unnecessary surgeries of genital system and after training, the individuals are participated in the group discussion and their questions are answered. They will refer for re completing the female sexual function index and the questionnaire of women’s mental image of their reproductive (genital) system four weeks after finishing the training sessions
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Centers in Qazvin
Full name of responsible person
Mina Sabbaghan
Street address
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Tabriz University of Medical Sciences
Full name of responsible person
Doctor Mohammad Reza Rashidi
Street address
Research department, Third floor, Central Construction Number 2, Tabriz Medical Science University, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
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, Tabriz 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
School of Nursing and Midwifery, Tabriz
Full name of responsible person
Mina Sabbaghan
Position
MSC Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, South Shariat St
City
Tabriz
Postal code
Phone
+98 912 781 9007
Fax
Email
sabbaghan.mina@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Tabriz
Full name of responsible person
Jamileh Malakouti
Position
Faculty of Nursing and Midwifery, Tabriz
Other areas of specialty/work
Street address
School of Nursing and Midwifery, South Shariati St