In this randomized clinical trial, 80 volunteer nulliparous women were eligible for inclusion (aged between 38 - 42 pregnancy weeks, cephalic presentation, the physical and mental health, no history of infertility, having a normal delivery conditions, opening of the cervix at a rate of 7.4 cm, having no history of allergy to date palm syrup) at the active phase of labor with cervical dilatation of 4 - 7cm were randomly divided into control and intervention with palm syrup group. Data collection in this study was divided into four main sections including demographic characteristics (age, education, employment status, willingness to current pregnancy, gestational age, abortion), recoding the controls in labor (during contractions, length contractions and fetal heart rate) and vaginal examinations (dilation, effacement, positions, stations, and the water bags), record fluid intake (date syrup or water) and recording the pain intensity using a ruler of 0 - 10 cm.
In this study, samples were randomly assigned to the palm syrup group (card No. 1) or placebo group (card No. 2). The first person who chose a card was randomly selected, and then placed in each of the two groups and the next person was placed in the other group. For example, if the first person chose the number two, he would be placed in the control group, and as a result, the next person would be in the palm syrup group, and again for the third one, both cards were submitted for selection. Also, none of the samples were aware of the nature of the numbers 1 and 2 cards, and after the selection of the card, the process of doing research was explained to them. The random allocation of samples was done by the researcher, but in order to prevent bias in the research, the researcher’s colleague (who was not aware of the nature of each person in each of the two groups) was used to record the severity of pain.
Throughout the research process, the researcher conducted the control and registration of all examinations personally in the intervention group and the control group, so that the length and intervals of uterine contractions and fetal heart rate at baseline and also every 30 min and dilatation, effacement, station, the membrane at baseline and then every 2 hours, through vaginal examination were examined in accordance with the protocols, and rebound support was continued by the researcher, despite the completion of the research where dilatation was 8 cm and until the end of the labor stage, because it was not morally correct to curtail the support. In order to prevent bias during the study, pain intensity was recorded by a researcher using a pain ruler, such that at the beginning of the study, and then for every 30 minutes, a research fellow with the 0 - 10 cm ruler recorded pain intensity and after the training of samples, they were asked questions regarding pain intensity.
In order to prepare the palm syrup, 6 palm crop products were mixed after extracting the core in a blender, mix thoroughly to ensure complete smoothness and it was prepared as a pulp free syrup mixed in 150 mL of water. Regarding the possibility of glucose effect on pain intensity, in this study, in the control group, only non-sweet liquids, including water or sugar-free tea, were presented as requested by the study samples.
Liquid preparation was recorded at baseline and then for every 30 minutes to 60 minutes and the volume of fluid intake was also recorded.
Regarding blindness in the present study, it should be noted that taking care of one to one care can affect the severity of pain, so all the care and controls performed during the labor cycle include vaginal examinations, examination of contractions, check fetal heart rate were taken by the researcher himself. Incidentally, this is strength point of the present research. Also, in order to blindness and preventing bias, the research team was used the fellow researchers to record the pain intensity. In fact, the fellow researchers, without any knowledge of the nature of the subjects studied in which of the two groups, recorded the severity of pain, on the other hand, the Statistician was also blinded until the analysis was completed.
For data analysis, SPSS V. 16 software was used. In order to identify demographic characteristics, analysis of variance, chi-square and Fisher’s exact test, and for determination of vaginal examinations, Kruskal-Wallis and chi-square tests, and also to compare the pain intensity, analysis of variance, Kruskal-Wallis test, and also due to the special nature of labor pain for more assessment, the Scheffe test, Mann-Whitney test, and repeated measures ANOVA and Bonferroni and Greenhouse-Geisser corrections were used.
This study was approved by the Ethics Committee of Tehran University of Medical Sciences (TUMS) with code: 132686-9111373029.