Research setting and design
The present randomized controlled trial with parallel control group will be conducted on all the pregnant women referring to Kowsar Hospital in Qazvin for labor that tended to participate in the study and met the inclusion criteria. Qazvin is the largest city and capital of the province of Qazvin in Iran and located in 150 km (93 mi) northwest of Tehran, in the Qazvin Province, it is at an altitude of about 1,800 m (5,900 ft) above sea level.
Intervention and comparator
The participants are divided into three groups, namely body acupressure (Intervention-1), auricular acupressure (Intervention-2), and routine care (Comparison) groups (Fig.1).
Inclusion and exclusion criteria
Inclusion criteria
The inclusion criteria in the present study included primigravida women, aging 19-35 years old, gestational age of 37-42 weeks, singleton pregnancy, cephalic presentation, no history of chronic diseases such as diabetes, cardiovascular diseases, hypertension, hepatic and renal disorders, etc., lack of pregnancy complications such as preeclampsia, gestational diabetes, bleeding, etc., height of above 150 cm, and admission at the beginning of the active phase (3-4cm dilation).
Exclusion criteria
Refusal to continue participation in the study, receiving pain relief drugs 3 h before or during the study, labor induction or enhancement by medications, and emergency CS birth constituted the exclusion criteria of this study.
Informed consent process
First author will explain the research objectives and method for those pregnant women having the inclusion criteria at the time of their admission to the labor and birth ward then, first author will obtain written consent from patients willing to participate in the trial.
Sample size estimation
To calculate the Minimal Clinically Important Difference (MCID) for the duration of the first stage of labor and the pain score, we used previous study data which examined the effect of auricular (24) and body (25) acupressure on labor pain intensity and labor duration. Using the method of Wyrwich et al, (26) MCID obtained 1 score for the score of pain. Using the G*Power software 3.1.9.2, α = 0.05 and power = 0.80, considering SD = 1.4 and M0 = 7.2 for the labor pain score and 10% drop in subjects, the sample size was calculated 30 patients for each group
Randomization and blinding
In order to determine the allocation sequence with 1:1:1 ratio, the person who isn't involved in the study will use the computer-generated 6-block randomization techniques. In order to allocation concealment, this person will write the type of intervention based on the predetermined sequence and put in opaque enveloped pockets; then, the pockets will be encoded. The questionnaires are encoded respectively as well. Accordingly, for a participant receiving the intervention in the pocket encoded with "1", a questionnaire with the same code will be completed. To observe blinding during data collection, one of the coworkers perform the intervention plan and another coworker who know nothing about the intervention, would collect the data. Finally, once the questionnaires are gathered and their data are imported into SPSS-16 software, it will be determined which codes should be assigned to Group-A and which codes to Group-B or C. Afterwards, analysis of the data will be performed. The person performing the data analysis would be also blind to the type of intervention of each group (Fig.1).
Follow-up
Assessments
Duration of the first stage of labor is determined in minutes and written in the questionnaire. To assess the pain score, a visual pain measurement VAS (visual analogue scale) ruler will be used at 4 and 10cm dilations. Furthermore, the midwifery and demographic characteristics questionnaires are completed after finishing the birth.
Administration of intervention
Selection of Acupoints is based on ear and body microsystems and meridians. There are some treatment plans that include a combination of some acupoints for every problem. These selections of points are originally derived from treatment plans developed in China, but modified by auriculotherapy discoveries in Europe and the United States. Theoretically every acupoints can exert some identified effect for the selected condition. (27-30). For the present research, a set of primary and master acupoints was selected. Using combination sets of points is proposed to be more effective than single points. As there was scant evidence on efficacy of applying multiple acupoints, researchers aimed to investigate efficacy of multiple acupoints on labor pain and duration.
In the body acupressure group, the pressure is applied to the GB30, GB21, BL32, LI4, and SP6 points (13, 29) by a researcher who had been well trained for this purpose. GB 21 point has an action of release and descent, which is purported to facilitate fetal descent in active phase and second stage of labor.(31) Stimulating LI 4 point is effective for reduction of labor pain and promoting stronger and/or more coordinated contractions.(9, 32-34) Stimulating BL 32 is effective for reduction of labor pain40 and induction of labor.(35, 36) One of the most important and frequently used points for obstetric and gynecologic concerns is SP 6. Indications of this point include labor augmentation, for irregular contractions to encourage efficient labor and reducing a persistent cervical lip (37-39) reduction of labor pain (34, 38-41) and reduction of the length of labor.(34, 38) To perform the acupressure on the specified points on the body, each point would be pressed by the thumb for 2 min, so that one-third of the nail bed became white. Pressure to these points would be applied at 4, 6, and 8cm dilations.
In the auricular acupressure group, the pressure would be applied to the Master auricular Points on the external ear (point Zero, Shen Men point, and thalamic point) and Primary auricular points (Uterus points 1 and 2, external genitalia point, oxytocin and/or prostaglandin points) (27) by a well-trained researcher. Ear acupoints are shown in figure 2. The master points are so identified because they are typically active in most patients and they are useful for the treatment of a variety of health disorders. Point Zero brings the whole body toward homeostasis, producing a balance of energy, a balance of hormones, and a balance of brain activity and is frequently combined with the Shen Men point for treatment of most health disorders. The purpose of Shen Men is to tranquilize the mind and to facilitate a state of harmony, serenity, and a deeper connection to one’s essential spirit. This master point alleviates stress, pain, tension, anxiety, depression, insomnia, restlessness, and excessive sensitivity. Thalamic point affects the relay of sensory information to the cerebral cortex and modulates hypothalamic regulation of autonomic nerves and endocrine glands. It is also used for alleviating most pain disorders, both acute and chronic. Primary auricular points are the most effective set of auricular points for the treatment of a health disorder in a particular body organ or for a physiological dysfunction.(27) The given pressure would be applied using an adhesive containing auriculotherapy-specific Vakharia seeds. Furthermore, auricular stimulation at the specified points would be performed every 30 min. It should be noted that the comparator group received the routine care (fig. 3).
Intervention fidelity
One of the researchers (MG) who is responsible for intervention is trained to perform auriculotherapy. Training and monitoring of her performance on implementing the intervention will be carried out by MV, who is expert in this field.
Primary outcome measurements
Pain score in first stage of labor: In the present study, the pain score (pain intensity) at 4 and 10 cm dilations is measured in all three groups using VAS scale and, then, compared.
Additional outcomes
Duration of first stage of labor: The present study is aimed to determine whether the auricular acupressure and body acupressure would reduce the duration of the first stage of labor in nulliparous women compared to the routine care.
Data collection and storage
Based on the predetermined allocation sequence, the studied women are divided into three groups, including auricular acupressure, body acupressure, and routine care groups. The pain score of all the participants would be measured at the peak uterine contraction at the 4cm cervical dilation and, then, recorded in the questionnaire. Subsequently, at 10 cm dilation, the pain score of all the participants in the three groups would be re-measured and recorded. Furthermore, in order to investigate the duration of the active phase of labor in these groups, the onset and termination times of the active phase of the first stage of labor are recorded in the questionnaire. The difference of these two recorded times indicated the duration of this stage. The remaining parts of the questionnaire are completed after the birth. Because it is not applicable Follow-up to this study we will not form the Data Monitoring Committee.
Data analysis
Once being collected, the data are imported into SPSS-16 software. Firstly, normality of the data distribution will be investigated (via three methods, including Kolmogorov-Smirnov, Histogram, and dispersion and central indices) and if the distribution of variables is not normal, then it will be used appropriate transformation. To compare the labor duration and pain score among the research groups, one way ANOVA test would be used, which will be followed, in case of significance, by Scheffe post-hoc test. If there is a potential confounding variables, the multiple linear regression test will be used. We will check for the assumptions and concerns of the regression model. Furthermore, Chi-squared test would be used to compare the categorized demographic variables in the studied groups. On the other hand, in order to compare the quantitative variables, in case of normal and abnormal distribution of the variables, ANOVA and Kruskal-Wallis tests are used, respectively. The post-hoc of these tests will be reported if needed. The study will be analyzed using an intention-to-treat (ITT) approach and using multiple imputation strategy to account for missing outcomes in ITT. Also, apropos of the significance level, 0.05 is considered significant.
Reporting of adverse events
Any kind of unwanted outcome in the participants will be reported.
Patient and public involvement
Patients and public were not directly involved in the development of this study protocol. However, the development of the research question and outcome measures is according the previous published studies on patients’ priorities, experience, and preferences. We will disseminate results to the study participants through the journal publication, as well as from research conferences.