Effect of Saffron with or without Date Sugar on Intensity of Pain, Anxiety and duration of active phase during Labor in Primiparous Women: A Randomized double-blind Controlled

Abstract

Abstract: Background: Labor pain is one of the most severe pain which women experience during their lifetime. One of the duties of midwives is to reduce the severity of pain and anxiety during labor and reduce the length of delivery stages. Use of non-pharmacological and complementary medicine is now increasing to reduce pain and anxiety in labor. One of these methods is the use of saffron and dates by some physicians and midwives, but scientific evidence in this regard is very limited. Therefore, this study aimed to examin effect of saffron with or without date on intensity of pain and anxiety during transitional and active phase of labor in primiparous women. Methods: In this superiority trial with three parallel arms, 96 primiparous women at the onset of active phase of labor were recruited at a hospital affiliated with the social security organization in Tabriz-Iran. They were randomized equally using block randomization into three groups; receiving 80 mL oral syrup of saffron (250 mg) plus date sugar (65 g), saffron (250 mg) plus artificial sugar (165 mg sodium saccharin and 420 mg sodium Carboxymethyl cellulose), or placebo every two hours for maximum three doses (240 mL, in case of no occurrence of any problems and no infant delivery). Intensity of pain and anxiety were assessed using 0-10 visual analogue scale at baseline, every one hour during labour, then one and 18 to 24 hours after delivery. Comparison of between groups was done using Repeated Measures ANOVA, ANCOVA, one-way ANOVA or Kruskal-Wallis. Results: Participants were recruited from 21 Jan to 22 Nov 2016. One from saffron plus date sugar, three from saffron plus artificial sugar and four from the placebo group were excluded due to emergency cesarean section. Compared with the placebo, mean score of both pain and anxiety on VAS 0-10 were lower in the intervention groups. The differences were statistically significant at the saffron plus date sugar group [adjusted mean difference (MD) -0.8 (95% CI -1.5 to 0.0), p=0.022 and MD -1.3 (95% CI -2.4 to -0.2), p=0.012, respectively] but were not significant at the saffron plus artificial sugar group [MD -0.5 (95% CI -1.2 to 0.2), p=0.322 and MD -1.1 (95% CI -2.2 to 0.0), p=0.058, respectively]. The differences between the two intervention groups were not statistically significant [MD -0.3 (95% CI -1.0 to 0.4), p=0.557 and -MD 0.2 (95% CI -1.3 to 0.8), p=0.927, respectively]. The mean length of active phase of the first stage of labor in the saffron plus date group was significantly lower than the placebo group (MD -81 min; 95% CI -136 to -27, p = 0.002) and the sugar saffron plus artificial sugar group (MD -61; 95% CI -115 to -6, P= 0.024). There was no statistically significant difference between saffron plus artificial sugar group with placebo (MD -21; 95% CI -77 to 35; P= 0.746).No serious maternal and fetal complications were observed in none of the groups. Conclusion: The results show the oral syrup of saffron plus date sugar could be used for reducing intensity of pain and anxiety during labor, and length of active phase of labour in primiparous women. However, the results were inconclusive about effects of saffron plus artificial sugar.