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IRCT20190226042845N1 IRCT 2020-04-21 Tehran University of Medical Sciences The effect of acupressure on the onset of labor pain and its outcome The effect of Auriculotherapy on cervical ripening, initition and outcome of labor in term primiparous women 2019-06-22 anticipated 90 Complete https://irct.ir/trial/38691 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Researchers referred to counseling centers, midwifery and health centers Society of Medical Sciences Qom after introducing his plan, sufficient information on the research, such as research, study objectives, criteria for inclusion and exclusion criteria, how to how to conduct the study in pregnant women explained. Individuals willing to participate in the research and have criteria for entering the study are referred to the researcher and are informed by the informed consent and informed by a continuous and available sampling method.The samples were then randomly assigned (Permuted-Block Randomization) to two intervention and placebo groups as follows. That all possibilities for placement of the letters A and B will be considered in four blocks that make up a total of 6 modes. The 6 modes are numbered 1 to 6 and the number of 4 blocks required will be determined based on the number of sample cases. Then the required number of blocks, random number based on random numbers table will burst row, the top 6 numbers will not be considered. Finally, based on the order of the numbers extracted from the table, the blocks for each number will be listed, respectively, and when each instance is entered into the study, each person will take a specific word in order. For example, in the order of (AABB / AABB), the 5th person will be in Group B.Randomly, half the people of each block are placed in one group and the other half in the other group. In this study, we want to place 90 people in two groups of 45 patients in the field of auriculotherapy and placebo, Blinding description: A placebo group has been identified to achieve the goal of blindness. In the placebo group, the procedure will be performed in such a way that the outer ear is cleansed ,Then several points from the same points in the intervention group that are effective for induction of childbirth are artificially Massage with a pointer machine, so that no stimulation is performed.Then on the 3rd point of the left ear and on the 3rd point of the right ear, there is a seed placed without vakaria.The pregnant mother is told not to press the points.The placebo group 72 hours after vaginal examination done to determine the Bishop score, also uterine contractions and fetal heart rate also examined. The placebo group is also evaluated from the time of admission to the completion of the delivery stages. N/A cervical ripening and labor initiation. Intervention 1: Intervention group: We randomly place 70 regnant women in the intervention and placebo groups. For each individual intervention group explained that auriculotherapy from 39 weeks to 40 weeks of pregnancy once done. If the cervix is unprepared and the labor pains do not begin 72 hours after the intervention, auriculotherapy is performed again. In the intervention group, before auriculotherapy to determine the Bishop score, vaginal exam as well as uterine contractions and fetal heart checked. For the preparation of cervix and the onset of labour, 11 points are stimulated: Shen Men, master shoulder , thalamic, Hypothalamus, prostaglandin, anterior pituitary, posterior pituitary, endocrine, (2) uterine, lumbar and lung. After disinfection of the ear with 75% alcohol and one minute of general massage for relaxation, electrical stimulation was performed with a Pointer Excel 2 (Made in China) device with a frequency of 2–4 Hz and a current intensity of 2–4 mA, each point is stimulated by the researcher for 15 seconds. . Finally, 5 points of left ear including endocrine, posterior pituitary, prostaglandin and uterus (2 points) and 5 points of right ear including Shen Men ,thalamic, master shoulder ,lung, lumbar are placed one vacaria seed. The mother is instructed to push each point up to 72 hours every hour for 1 minute. Seed pressure should be enough power to cause pain and irritation of the outer ear.They may also experience different sensations when seed pressure, such as numbness, swelling, mild pain or heat. It should be noted that during sleep and rest for 8 hours do not need to squeeze. To prevent forgetfulness, the researcher remembers pressing the points by phone, asking for possible problems and complications. Intervention 2: Placebo group: The placebo group will consist of 35 pregnant women who are eligible for the study. In this group, the outer ear is cleaned with 75% alcohol and then several points from the same points in the intervention group are massaged with the silent machine so that the stimulation is not triggered. It is then placed on the 3 points of the left ear including the thalamic, Shen Men, lung and the 3 points of the right ear including the posterior pituitary, prostaglandin and the uterus of a seed without vakaria. The pregnant mother is told not to push the points at all. Yes - There is a plan to make this available What will be shared: Only part of the data, such as information about the original outcome or the like, can be shared When: Start of access period 6 months after printing results To whom: Data can be obtained by researchers and people who are in treatment. Conditions: Data can be obtained by researchers and people who are in treatment. Where to obtain: z.mozafarirad.midwif@gmail.com How to obtain: z.mozafarirad.midwif@gmail.com Comments:
public Zeynab Mozafari Rad
College of Nursing and Midwifery, Tehran University of Medical Sciences, Tohid Square, Tehran, Iran
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6692 7171 z.mozafarirad.midwif@gmail.com Tehran University of Medical Sciences scientific Zohreh Khakbazan
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Tohid Square, Tehran, Iran
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6692 7171 khakbaza@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: All pregnant women with gestational age of 39 weeks to 40 weeks Primiparous Age 18-35 Years Pregnancy is low risk (Lack of any known internal and surgical disease and complications associated with pregnancy) Fetus with cephalic presentation Bishop Cervical Score Less than 4 before the study Single pregnancy Index Body mass 19.8 to 30 Estimated fetal weight less than 4000 grams Healthy amniotic sac (Also lack of oligo and poly hydramnios) Lack of stenosis of the pelvis Lack of sex 72 hours before the study No use of any complementary or traditional method for induction of labor Lack of uterine contractions External ear on both sides with no lumps, swelling, infection or wound for auriculotherapy 18 years 35 years Female Breech presentation High risk pregnancy such as gestational diabetes, high blood pressure in pregnancy, Previa Estimated fetal weight over 4000 grams Bleeding before and during the study Stripping before starting the study Decrease fetal movement Use of any complementary or traditional method for induction of labor Nipple stimulation during study Rupture of the amniotic sac before the start of the study No pressure points in 1full day Cancellation and dissatisfaction with the mother of auriculotherapy Request termination of pregnancy by elective cesarean section or pharmaceutical methods 080.0 Spontaneous vertex delivery Treatment - Other Treatment - Other Intervention group: We randomly place 70 regnant women in the intervention and placebo groups. For each individual intervention group explained that auriculotherapy from 39 weeks to 40 weeks of pregnancy once done. If the cervix is unprepared and the labor pains do not begin 72 hours after the intervention, auriculotherapy is performed again. In the intervention group, before auriculotherapy to determine the Bishop score, vaginal exam as well as uterine contractions and fetal heart checked. For the preparation of cervix and the onset of labour, 11 points are stimulated: Shen Men, master shoulder , thalamic, Hypothalamus, prostaglandin, anterior pituitary, posterior pituitary, endocrine, (2) uterine, lumbar and lung. After disinfection of the ear with 75% alcohol and one minute of general massage for relaxation, electrical stimulation was performed with a Pointer Excel 2 (Made in China) device with a frequency of 2–4 Hz and a current intensity of 2–4 mA, each point is stimulated by the researcher for 15 seconds. . Finally, 5 points of left ear including endocrine, posterior pituitary, prostaglandin and uterus (2 points) and 5 points of right ear including Shen Men ,thalamic, master shoulder ,lung, lumbar are placed one vacaria seed. The mother is instructed to push each point up to 72 hours every hour for 1 minute. Seed pressure should be enough power to cause pain and irritation of the outer ear.They may also experience different sensations when seed pressure, such as numbness, swelling, mild pain or heat. It should be noted that during sleep and rest for 8 hours do not need to squeeze. To prevent forgetfulness, the researcher remembers pressing the points by phone, asking for possible problems and complications. Placebo group: The placebo group will consist of 35 pregnant women who are eligible for the study. In this group, the outer ear is cleaned with 75% alcohol and then several points from the same points in the intervention group are massaged with the silent machine so that the stimulation is not triggered. It is then placed on the 3 points of the left ear including the thalamic, Shen Men, lung and the 3 points of the right ear including the posterior pituitary, prostaglandin and the uterus of a seed without vakaria. The pregnant mother is told not to push the points at all. Cervical ripening. Timepoint: Before intervention, 72 and 144 hours after intervention and hospitalization time. Method of measurement: Vaginal examination. Initiation labour. Timepoint: Before intervention, 72 and 144 hours after intervention and hospitalization time. Method of measurement: examination. The length of the first stage of labor. Timepoint: The end of the study. Method of measurement: Researcher-made questionnaire. The length of the second stage of labor. Timepoint: The end of the study. Method of measurement: Researcher-made questionnaire. Baby Apgar. Timepoint: The end of the study. Method of measurement: Researcher-made questionnaire. Type of delivery. Timepoint: The end of the study. Method of measurement: Researcher-made questionnaire. Use of Oxytocin. Timepoint: The end of the study. Method of measurement: Researcher-made questionnaire. Tehran University of Medical Sciences Approved 2019-02-02 Organizational Ethics Committee for Research in School of Nursing and Midwifery and School of Rehabi Tehran University of Medical Sciences, Tehran, Tohid Square, Dr. Mirkhani St. (East Nursing) Tehran Tehran Iran (Islamic Republic of)