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The effect of saffron syrup on the labor pain intensity, anxiety and duration of labor

Phase 3
Conditions
ormal labor and delivery.
Spontaneous vertex delivery
Registration Number
IRCT201507073706N26
Lead Sponsor
Vice chancellor for research, Tabriz University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Female
Target Recruitment
96
Inclusion Criteria

aged 18 to 35 years; nulliparous; gestational age of 38 to 41 weeks; spontaneous onset of labor; singleton pregnancy with estimated fetal weight of 2500 to 4000 grams and cephalic presentation; no use of any herbal and anti anxiety drugs in the past 12 hours; reactive non stress test; body mass index of 19.8 to 30 kg/m²; having 8 years education or higher.
Exclusion criteria: history of surgery on the uterus, cervix or vagina; allergy to saffron; known chronic diseases including hypertension, diabetes, diseases of the respiratory, cardiovascular, endocrine, etc.; history of mental illnesses; speech, hearing, visual or mental problems; known indications for caesarean section; premature rupture of membranes for more than 12 hours; any known fetal abnormalities; known fetal growth retardation

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Severity of labor pain. Timepoint: every one hour from about 3 cm cervical dilation to the end of the second stage of labor; one and 18 to 24 hours after delivery. Method of measurement: visual analogue scale (VAS) for pain.;Intensity of anxiety. Timepoint: at baseline, 3 to 4 hours after starting intervention, and 18 to 24 postpartum. Method of measurement: Spielberger state questionnaire and visual analogue scale for anexity.
Secondary Outcome Measures
NameTimeMethod
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