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IRCT20110606006709N23 IRCT 2021-09-13 Tabriz University of Medical Sciences The effect of Saccharomyces Cerevisiae enriched with selenium and mineral selenium on postpartum depression and sexual satisfaction مقایسه تاثیر مخمر ساکارومایسس سروزیه غنی شده با سلنیوم و سلنیوم معدنی بر افسردگی بعد از زایمان و میزان رضایت جنسی Comparison of the effect of Saccharomyces Cerevisiae enriched with selenium and mineral selenium on postpartum depression and sexual satisfaction:A triple-blind randomized controlled trial 2021-08-02 anticipated 108 Complete https://irct.ir/trial/56771 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Breastfeeding women with mild to moderate depression scores using a randomized blocking method with a size of three or six blocks using RAS (Random Allocation Software) with a 1: 1: 1 allocation ratio in The three groups receiving Saccharomyces cerevisiae enriched with selenium, mineral selenium and placebo will be included. To hide the allocation, the group name will be placed inside a numbered consecutive matte envelope. Envelope preparation and random allocation sequencing will be performed by the non-research person, Blinding description: The drugs and their placebo will be prepared by the pharmaceutical company in a completely similar way in terms of shape, color and smell. The researcher, participants, data analyst, and outcome reviewer are unaware of the type of intervention received. 3 Postpartum Depression. Intervention 1: Intervention group 1: Capsules containing Saccharomyces Cerevisiae enriched with selenium 200 micrograms, one for 8 weeks. Drugs will be made in the Faculty of Nutrition of Tabriz University of Medical Sciences by the Department of Pharmacy Dr. Ostad Rahimi. Intervention 2: Intervention group 2: Capsules containing mineral selenium 200 micrograms, one for 8 weeks. Drugs will be made in the Faculty of Nutrition of Tabriz University of Medical Sciences by the Department of Pharmacy Dr. Ostad Rahimi. Intervention 3: Control group: Capsules containing placebo, one for 8 weeks. Placebo will be made in the Faculty of Nutrition of Tabriz University of Medical Sciences by the Department of Pharmacy Dr. Ostad Rahimi. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is After the completion of the project the decision will be made
public Parnian Rahimi
Faculty of Nursing and Midwifery, South Shariati Street
Tabriz Iran (Islamic Republic of) 5415933739 +98 41 3475 3906 parnian9797.md@gmail.com Tabriz University of Medical Sciences scientific Mahnaz Shahnazi
Faculty of Nursing and Midwifery, South Shariati Street.
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3477 2699 mshahnazi@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Women over 18 years who are in the first 15 to 90 days after giving birth. Willingness to participate in research Having a record of care in health centers 18 years 45 years Female A score above 23 on the Edinburgh Questionnaire History of depression or any other mental disorder Death or hospitalization of the baby in the intensive care unit Stillbirth Hospitalization of the mother due to postpartum complications Having chronic diseases such as liver and kidney disease Allergy to fungi and yeast Loss of loved ones between two months before delivery and two months after delivery Having frequent miscarriages and having a history of infertility Having a history of a child with a mental or physical disability Divorce over the past three months O90.6 Postpartum mood disturbance Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: Capsules containing Saccharomyces Cerevisiae enriched with selenium 200 micrograms, one for 8 weeks. Drugs will be made in the Faculty of Nutrition of Tabriz University of Medical Sciences by the Department of Pharmacy Dr. Ostad Rahimi Intervention group 2: Capsules containing mineral selenium 200 micrograms, one for 8 weeks. Drugs will be made in the Faculty of Nutrition of Tabriz University of Medical Sciences by the Department of Pharmacy Dr. Ostad Rahimi. Control group: Capsules containing placebo, one for 8 weeks. Placebo will be made in the Faculty of Nutrition of Tabriz University of Medical Sciences by the Department of Pharmacy Dr. Ostad Rahimi. Depression score. Timepoint: Before and after the intervention at intervals of 8 weeks. Method of measurement: Edinburgh Depression Inventory. Sexual satisfaction. Timepoint: Before and after the intervention at intervals of 8 weeks. Method of measurement: Sexual Satisfaction Questionnaire. Side events. Timepoint: During 8 weeks of intervention. Method of measurement: Side accident assessment form. Tabriz University of Medical Sciences Approved 2021-07-05 Ethics Committee of Tabriz University of Medical Sciences Research department, third floor, central construction number 2,Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)