The present study was a randomized clinical trial and open label investigating the effects of C. aurantium on labor pain. The study was conducted with the permission of vice president for registrar affairs of Shahid Beheshti Medical University and approval of the University Ethics Committee. Written consent was acquired from the participants and the clinical trial was registered on the website of the Ministry of Health. The study was registered in the Iranian Center for Clinical Trials under registration No. N6 201301306807 IRCT. After consulting with statistical professor the minimum number of sample size calculated through the below formula:
A total of 126 pregnant women admitted to Valie-asr Hospital in Toyserkan (Hamadan Province, West of Iran) who were eligible to participate in the study were chosen through simple method of randomization. Sampling was carried out between June and September, 2013. The inclusion criteria were: Iranian ethnicity, being primiparous, aged between 18–35 years, full-term pregnancy, singleton pregnancy, cephalic presentation of the fetus, having automatic contractions, examining the dilatations (3–4 cm) at the moment of enrolling in the study, suitable pelvis status, having intact amniotic sac, not having consumed painkillers within 8 hours before enrolling in the study, absence of any identified liver, pancreas or respiratory diseases, not suffering from pregnancy and obstetric symptoms (e.g., preeclampsia, chorioamnionitis, placenta abruption, abnormal fetal heart rate at the moment of enrolling in the study), absence of olfactory disorders or sensitivity to herbal medicine according to the participant.
Participants were excluded from the study if urgent cesarean section was required before completion of the study, unbearable sensitivity to
C. aurantium experienced, and the presence of signs indicating delivery, such as vaginal bleeding. The researchers chose the eligible participants from patients in the obstetrics ward of Valie-asr Hospital and provided them with necessary information. A written consent was obtained from all participants. The eligible primiparous women were then assigned on random days to either the
C. aurantium or control groups. Randomization of the days was carried out using randomized table of numbers and on each day only aromatherapy or normal saline was used. The
C. aurantium distillated water used in this study was produced by the Garreban Company, Iran. Each 100 mL of the product contained 8 mg
C. aurantium oil, the density of which was measured and approved by the School of Pharmacy, Shahid Beheshti Medical University. In the aromatherapy group, gauze squares were soaked in 4 mL
C. aurantium distillated water and in the control group gauzes were soaked in 4 mL of normal saline and were attached to the participants’ collars, with the intervention repeated every 30 min. The women’s pain severity was measured before and after intervention at dilatation stages of 3–4, 5–7, and 8–10 cm. Data analysis was carried out using the demographic and obstetrics questionnaire, observation and exam checklist, and the numerical scale of pain measurement. In order to examine the validity of the demographic and obstetrics questionnaire content validity method was implemented. In this way after reviewing related articles and reference books and according to the objectives of the research the demographic and obstetrics questionnaire perpetrated and approved by 10 members of Midwifery Faculty of Shahid Beheshti Medical University. In order to investigate the stability of the observation and examination checklist, parallel reliability was implemented. The observation and examination checklist completed by researcher and a colleague with experience matched with researcher for 10 Participants and the correlation coefficient was 0.85. The numerical pain scale has consistent correlation with other pain measurement scales (
22) and has been used in other studies (
14,
23-
25). In a controlled randomized clinical trial in admitted patients in the first and second days after Cardiac surgery, the stability of the two pain rulers (
i.e., visual and numerical) were measured using a 15-minute retest where the stability for the visual scale was between 0.73–0.82 and the numerical 10-digit score was 0.72–0.78 (
26). Farrar
et al. (
27) carried out a retest in a 7–14-day interval to evaluate the reliability of the numerical pain scale and determined a correlation coefficient of 0.83. The pain measuring instrument is scaled from 0 to 10 with 0–3 indicating ‘mild pain’, 4–7 ‘moderate pain’ and 8–10 ‘severe pain’. The gathered data were analyzed using SPSS v22, independent T test, Chi-squared and Mann-Whitney U test. Parametric tests were performed where the data were normally distributed.