DOI: https://doi.org/10.21203/rs.1.20/v1
Labor pain is one of the most intense pains experienced by women during their lifetime.(1, 2) Labor pain is caused by the interaction of physiological factors, such as uterine contractions and cervical dilation, and psychological factors, such as fear and anxiety.(3) Labor pain engenders an experience, from which most women tend to avoid and is always a source of anxiety and distress for pregnant women.(4) A considerable portion of C-section (CS) deliveries has been performed merely due to mothers' fear from labor pains.(5)
Labor pain relief methods are divided into two major groups, namely pharmacological and non-pharmacological techniques.(6) The most common technique for relieving pain of labor is the use of medications, known as pharmacological methods. However, the potential side-effects of pharmacological methods for fetus and mother have resulted in a growing interest in the use of non-pharmacological labor pain relief techniques.(7)
Acupressure is a non-pharmacological pain relief method, which is based on the principles of TCM (traditional Chinese medicine). There are several acupressure points on the body for the progression of birth and reduction of its pain, the stimulation of which is believed to induce stimulation of uterine contractions and, consequently, progression of birth, on the one hand, and balance of energy as well as reduction of labor pain, on the other hand.(8) Among the numerous points used in acupuncture and acupressure for labor induction and management, the Sanyinjiao (SP6), Taichong (LV3), Ciliao (BL32), Weishu (BL21), Shangliao (BL31), and Hogu (LI4) can be mentioned.(8) Various studies have reported reduced labor pain achieved by single stimulation or a combination of two points.(9-12) Besides, the GB21, BL32, LI4, and SP6 are the major points commonly proposed for enhancing uterine contractions, hard and prolonged labor, and dropping improvement. Results of an observational study of women receiving acupuncture as part of their antenatal care showed 35% reduction in the use of labor induction, 31% reduction in epidural analgesia, 9% increase in the natural birth success rate, as well as shorter duration of labor among the women in the group undergoing acupuncture compared to the local population rates.(13) Moreover, in a systematic review conducted to investigate the effect of acupressure on the onset and duration of labor, Mollart et al. (2015) reported acupressure could significantly reduce labor duration in the intervention group compared to the standard care and control groups.(14) Theoretically, when labor has a slow procedure and contractions are not intense enough, the cervical dilation will be slow as well. Stimulating the acupoints (acupuncture and acupressure points) can yield a balanced labor by adjusting the contractions and improved contractions can thereby lead to reduced labor duration.(15)
Auriculotherapy (AT) (also known as auricular therapy) is a branch of acupressure spreading throughout the world. Auricular therapy is based on long-standing tradition and was modified and updated by Dr. Paul Nogier, the , the ified and updated by Dr. Paul Nogier, the . Pa Health Organization considers auricular therapy a form of microacupuncture that can affect the whole body.(16) AT subsumes several types including auricular acupuncture, electro stimulation, and acupressure. Various studies have reported promising results in terms of the effects of using AT on the control of pain caused by backache,(17) pelvic fractures,(18) dysmenorrhea,(19-21) and polycystic ovarian syndrome.(22) However, there are only a limited number of studies on the effect of auriculotherapy on labor pain, which have yielded inconsistent results. Accordingly, in Rastegarzadeh's work, auriculotherapy led to a significant reduction in the labor pain among nulliparous women, whereas Maftoni's study indicated that use of auriculotherapy caused no significant reduction in the studied women's labor pain.(23, 24)
As can be inferred from investigations, most of the studies on body acupressure have more frequently applied pressure on one or two points; only a few studies have been focused on a combination of the points affecting the pain and progress of labor. Furthermore, some studies have been conducted on the effect of auricular acupressure on the reduction of different pain throughout the body, the results of which have confirmed the effectiveness of this technique. However, only a few studies have addressed the effect of auricular acupressure on labor pain, which have yielded inconsistent results.(3, 4) As few number of studies on the effect of body acupressure at multiple points and auricular acupressure on the pain and duration of labor, the present study were designed. In the present clinical trial, the primary objective is to compare the effects of auricular acupressure, body acupressure, and routine treatment on the pain score in the 4cm and 10cm cervical dilations. Besides, the secondary objective is to investigate the effects of the described interventions on the duration of the first stage of labor, which is defined as the time interval between the 4cm and 10cm cervical dilations. This is a single-center, parallel, double blinded randomized controlled trial to investigate the superiority of auricular acupressure, body acupressure compared with routine care during first stage of labor. Allocation ratio of each group is 1:1:1.
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 had 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.(25) 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
In the body acupressure group, the pressure is applied to the GB30, GB21, BL32, LI4, and SP6 points (13, 27) 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.(28) Stimulating LI 4 point is effective for reduction of labor pain and promoting stronger and/or more coordinated contractions.(9, 29-31) Stimulating BL 32 is effective for reduction of labor pain40 and induction of labor.(32, 33) 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 (34-36) reduction of labor pain (31, 35-38) and reduction of the length of labor.(31, 35) 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) (39) by a well-trained researcher. 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.(39) 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. 2).
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.
Improving the health of mothers and babies is one of the international obligations of the country in line with the Millennium Developing Goals. Achieving these goals involves reducing the maternal and neonatal mortality rate due to complications of pregnancy and delivery, reducing the cesarean section without indication and promoting normal delivery (40). One way to promote natural childbirth, is a painless labor. The American College of Obstetricians and Gynecologists has confirmed that the request for pain relief from the patient is indicative of the need for pain relief (41). Labor pain relief methods are divided into non-pharmacological methods and pharmaceutical methods. Hypnosis, Acupuncture, Therapeutic Touch, Relaxation, Massage Therapy, Music Therapy and ... are non-pain relief methods (6). Systemic medications, inhalation anesthesia, local anesthesia and general anesthesia are drug methods of pain relief (41).
Based on available scientific resources, massage can reduce labor pain by gates control mechanism the of pain. In this way, massage activates large neural fibers and closes the gates of pain transfer. Another theory in this area is that massage may release endorphins and thereby reduce the pain (42). In this study will compare effect of auricular acupressure and body acupressure on labor pain. Also, the effect of two noted methods will study on duration of first stage of labor.
Trial status
Recruitment has begun since August 2018 and is still ongoing. Data collection will probably complete in December 2018.
Author Contributions
FK, ZA, and MV designed the study and prepared the protocol. MG performed the interventions and ZA carried out the data collection and completion of the questionnaires. All the authors scrutinized and confirmed the final protocol.
Funding
This work is supported by Vice Chancellor for Research and Technology, Qazvin University of Medical Sciences, Qazvin, Iran. But no financial support would be received to disseminating and publishing protocol and results of the study.
Ethical Approval and Consent to participate
After explaining the aim and procedure of study and their autonomy to involve or leave study, written informed consent will be acquired. Participation in the study would be voluntary and the participants would be reassured that their refusal to participate in the project would have no impact on their required care services. Personal contact information would be accessible only to the research team members. The questionnaires will be completed using codes assigned to patients (and without mentioning patients' names). The results of this study will be disseminated at several research conferences and as published articles in peer-reviewed journals. The present study protocol was prepared in accordance to the Standardized Protocol Items: Recommendations for Intervention Trials (SPIRIT) statement (43) (Table 1). The present study is established in Committee of Ethics, Qazvin University of Medical Sciences and coded IR-QUMS.REC.1396.416. In addition, it has been registered in Iranian Registry of Clinical Trials with the code of IRCT20180218038789N1 in 2018-03-04. If important modifications are made, the Ethics Committee of the Qazvin University of Medical Sciences would be informed, and new protocols would be uploaded to IRCT.
Consent for publication
Not applicable.
Availability of supporting data
Original research data could be requested from the corresponding author.
Competing interests
The authors declare that they have no competing interests.
Authors' information
1 Ph.D. Assistant Professor of Midwifery, Social Determinants of Health Research Center, Qazvin University of Medical Sciences, Qazvin, Iran. 2 Ph.D. Department of midwifery, school of nursing and midwifery, Hamadan University of Medical Sciences, Hamadan, Iran. 3 PhD. Nursing and Midwifery Care Research Center, Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran. 4 MSc. Kowsar clinical & educational center, Qazvin University of Medical Science, Qazvin, Iran.
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