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IRCT20190427043398N1 IRCT 2019-06-02 Shahid Beheshti University of Medical Sciences To Determine the Effect of Education of Sexual Health Promotion Package in Woman During Pregnancy The Study of Effect of Education of Sexual Health Promotion Package on Sexual Health Dimensions of Pregnant Women 2018-09-01 anticipated 225 Complete https://irct.ir/trial/39810 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The sampling method was done by cluster random sampling in areas of Rasht. In the beginning, Rasht was divided into five regions (East, West, North, South, and Center). The name of the five regions was written separately on paper. Simple randomly was drawn and three regions (East, West, Center) were selected. Then again, in each cluster (region), the name of comprehensive health care centers was written separately on a paper and was simple randomly drawn. In the lottery, the first name of the center was in the intervention group; the second name of the center was in the self-education group and the third in the control group (Three centers in each area). N/A Sexual Health. Intervention 1: First Intervention group: Face-to-Face training is provided to pregnant women in three sessions -90 minute- during pregnancy (first session in the first trimester, second session in the second trimester, third session in the third trimester); through lecture, Question and Answer training provided by the researcher. The Sexual Health Package was designed based on the clinical guidelines of NICE. According to this pattern, the package was designed after searching in the guidelines, books, sexual health packages of various countries, as well as articles. Then, the sexual health package was validated by the Delphi method, using the opinions of specialists and experts in various cities of Iran. This package (In two parts for health care providers and pregnant women) was designed to provide educational content that include the most important aspects of sexual health during pregnancy (for each trimester of pregnancy, an educational session). Intervention 2: Second intervention group: Self-educated group: Sexual health package (package of pregnant women) was given to them at the beginning of pregnancy. Intervention 3: Control group: Just Routine care was taken in the control group and they did not receive any training packages and intervention. Routine care is prenatal care, which is done based on Iran's Ministry of Health's Pregnancy Care Guidelines and WHO guidelines, such as vaccination, blood pressure control, weight measurement, nutrition counseling for pregnant women. Yes - There is a plan to make this available What will be shared: A report including An Introduction, Methodology, Results and Discussion When: The data will be accessible 6-12 month after publishing the results. To whom: researchers in academic institutes were allowed to access data Conditions: with stating the reference Where to obtain: sending email to corresponding author through: g.ozgoli@gmail.com How to obtain: A application letter must include the name of the applicant, used item, scientific title of the research project or article. Comments:
public Shiva Alizadeh
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Niayesh intersection., Vali-e-Asr street.,
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8820 2512 shiva.alizadeh@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Giti Ozgoli
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Niayesh intersection., Vali-e-Asr street.,
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8820 2512 g.ozgoli@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: gestational age less than 14 weeks; women’s age between 15- 45 years; Having informed consent to participate in the study; Lack of history of medical diseases; lack of consumption of the medication that affect sexual function; lack of drug addiction; lack of high risk pregnancy criteria; lack of experience of an acute stress during recent years such as child’s death, acute illness, etc. 15 years 45 years Female Unwillingness of pregnant women to participate in the study Z70.9 Sex counseling, unspecified Behavior Behavior Behavior First Intervention group: Face-to-Face training is provided to pregnant women in three sessions -90 minute- during pregnancy (first session in the first trimester, second session in the second trimester, third session in the third trimester); through lecture, Question and Answer training provided by the researcher. The Sexual Health Package was designed based on the clinical guidelines of NICE. According to this pattern, the package was designed after searching in the guidelines, books, sexual health packages of various countries, as well as articles. Then, the sexual health package was validated by the Delphi method, using the opinions of specialists and experts in various cities of Iran. This package (In two parts for health care providers and pregnant women) was designed to provide educational content that include the most important aspects of sexual health during pregnancy (for each trimester of pregnancy, an educational session). Second intervention group: Self-educated group: Sexual health package (package of pregnant women) was given to them at the beginning of pregnancy. Control group: Just Routine care was taken in the control group and they did not receive any training packages and intervention. Routine care is prenatal care, which is done based on Iran's Ministry of Health's Pregnancy Care Guidelines and WHO guidelines, such as vaccination, blood pressure control, weight measurement, nutrition counseling for pregnant women. Sexual Response in pregnancy. Timepoint: Before intervention; At the beginning of each subsequent intervention; Four weeks after the last intervention. Method of measurement: Pregnancy Sexual Response Inventory (PSRI). Sexual function. Timepoint: Before intervention; At the beginning of each subsequent intervention; Four weeks after the last intervention. Method of measurement: Female Sexual Function Index (FSFI). Sexual Quality of life. Timepoint: Before intervention; At the beginning of each subsequent intervention; Four weeks after the last intervention. Method of measurement: Sexual Quality of life Questionnaire. Sexual Violence. Timepoint: Before intervention; At the beginning of each subsequent intervention; Four weeks after the last intervention. Method of measurement: Sexual Violence Questionnaire. Shahid Beheshti University of Medical Sciences Approved 2016-07-18 Ethics committtee of Shahid Beheshti University of Medical Sciencesty Shahid Beheshti University of Medical Sciences., Arabi Ave., Daneshjoo Blvd., Velenjak. Tehran Tehran Iran (Islamic Republic of)