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IRCT201707133860N30 IRCT 2017-08-08 Vice Chancellor for research of Shahid Beheshti University of Medical Sciences Effect of saffron on labor anxiety Effect of saffron capsule on labor anxiety in primiparous women 2017-09-23 anticipated 60 Complete https://irct.ir/trial/3994 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Single, Purpose: Treatment. N/A anxiety. Intervention 1: Saffron capsule In this research, Goldaro Company produced 50 g of weighed saffron powder with powdered electric pulp and percolated with 70% alcohol percolation for 72 hours extraction. Then, it was mixed with 105 grams of excipient and 0.52 grams of magnesium stearate to smooth the granule in an electric mixer. The resulting granules were then injected into a laboratory filling machine and 250 mg capsules of the above granules were prepared. Intervention 2: Placebo Capsule In order to remove the bias in the control group, the placebo containing 250 mg of lactose powder was prepared.
public Giti Ozgoli
Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Valleye Asr street, Tehran, Iran.
Tehran Iran (Islamic Republic of) +98 21 8820 2012 gozgoli@gmail.com Shahid Beheshti University of Medical Sciences scientific Giti Ozgoli
Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Valleye Asr street, Tehran, Iran
Tehran Iran (Islamic Republic of) +98 21 8820 2012 gozgoli@gmail.com Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Shahid Beheshti Un Iran (Islamic Republic of) Inclusion criteria: age between 18 to 35, first pregnancy; single pregnancy pregnancy; embryonic cephalic presentation; gestational age 40 to 41 weeks or more based on the first day of the last menstruation and ultrasonography of the first trimester; no uterine contraction; bishop score lower or equal to 4; healthy gestational sac; regular fetal heart rate; normal non-stress test; estimated embryo weighing 2500-4000; a low risk pregnancy (no known signs of internal and surgical diseases, or complications such as preeclampsia and Placental abruption and absence of known embryonic problems); pelvic stenosis; don’t receive any herbal remedy or medication such as misoprostol, prostaglandin, Oxytocin 36 hours before treatment; no sexual intercourse from 24 hours before and up to the end of the study. Exclusion criteria: oral consumption of saffron; uterine contraction; fetal heart rate abnormalities and absence of fetal movement, use of stimulants for uterine contractions during the study; such as castor oil; midwifery requiring emergency procedures, such as intense hemorrhage. 18 years 35 years Female F41.1 Anxiety that is generalized and persistent but not restricted to, or even strongly predominating in, any particular environmental circumstances (i.e. it is Treatment - Drugs Placebo Saffron capsule In this research, Goldaro Company produced 50 g of weighed saffron powder with powdered electric pulp and percolated with 70% alcohol percolation for 72 hours extraction. Then, it was mixed with 105 grams of excipient and 0.52 grams of magnesium stearate to smooth the granule in an electric mixer. The resulting granules were then injected into a laboratory filling machine and 250 mg capsules of the above granules were prepared. Placebo Capsule In order to remove the bias in the control group, the placebo containing 250 mg of lactose powder was prepared Anxiety. Timepoint: at the time of entering the study-- when admitted to the labor sector. Method of measurement: Spielberger anxiety questionnaire. Vice Chancellor for research of Shahid Beheshti University of Medical Sciences Approved 2016-07-20 Ethics Committee of Pharmacy and Nursing Schools, Midwifery School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Valleye Asr street, Tehran, Iran. Tehran Iran (Islamic Republic of)