This double-blind clinical trial aims to determine the effect of saffron oral capsule on labor anxiety in primiparous women. 60 pregnant women with a gestational age of 40 weeks or more who are referred to the hospital and Darul-Shafa Hospital of Zahraye Marzieh in Isfahan city were selected by simple sampling method and in the process of random appointment of individuals in groups will use Random allocation software for clinical trial. The drug packs were numbered in two codes, A and B, to 60, containing 3 capsules of saffron or placebo (code-packed). In order to remove the bias in the control group, placebo containing 250 mg of lactose powder and saffron capsules and placebo in terms of appearance, including odor and color were similar.Blinding was performed for two groups of subjects (patients) and researchers.
After obtaining the written consent of the eligible individuals, they receive the envelope in the code in which they receive. In each group, at the beginning of the 40th week of gestation, a capsule of saffron or placebo is given in a dose of 250 mg per night to 3 nights. After three days from the beginning of the 40th week, they are admitted based on the routine of the center. The degree of anxiety will be measured in two stages (at the time of entering the study, when admitted to the labor sector). The instruments of this study were demographic and midwifery questionnaires and Spielberger anxiety questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201707133860N30
Registration date:2017-08-08, 1396/05/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-08, 1396/05/17
Registrant information
Name
Gity Ozgoli
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 2512
Email address
gozgoli@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-03-16, 1396/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of saffron capsule on labor anxiety in primiparous women
Public title
Effect of saffron on labor anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
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.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Pharmacy and Nursing Schools, Midwifery
Street address
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Valleye Asr street, Tehran, Iran.
City
Tehran
Postal code
Approval date
2016-07-20, 1395/04/30
Ethics committee reference number
IR.SBMU.PHNM.1395.438
Health conditions studied
1
Description of health condition studied
anxiety
ICD-10 code
F41.1
ICD-10 code description
Anxiety that is generalized and persistent but not restricted to, or even strongly predominating in, any particular environmental circumstances (i.e. it is
Primary outcomes
1
Description
anxiety
Timepoint
at the time of entering the study-- when admitted to the labor sector
Method of measurement
Spielberger anxiety questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
Placebo Capsule In order to remove the bias in the control group, the placebo containing 250 mg of lactose powder was prepared
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
the hospital and Darul-Shafa Hospital of Zahraye Marzieh in Isfahan city
Full name of responsible person
Street address
Hospital and Dar ul-Shafa Hazrat Zahraye Marzieh (SA)- Sahib Ibn Abbad Alley- Ghods Square- Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Giti Ozgoli
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Valleye Asr street, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 8820 2012
Fax
Email
gozgoli@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Shahid Beheshti Un
Full name of responsible person
Giti Ozgoli
Position
Phd in Reproductive Health
Other areas of specialty/work
Street address
Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Valleye Asr street, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8820 2012
Fax
Email
gozgoli@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Giti Ozgoli
Position
Phd in reproductive health
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
+98 21 8820 2012
Fax
Email
gozgoli@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)