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IRCT20201020049086N1 IRCT 2021-06-19 Shahid Beheshti University of Medical Sciences The effect of Ear acupressure on lactation of women who underwent caesarean sections The effect of Auriculotherapy on Lactation of Women who underwent Caesarean sections 2021-06-24 anticipated 86 Complete https://irct.ir/trial/51755 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Block randomization method, using an Excel spreadsheet. In the Excel spreadsheet the leftmost column shows the total number of participants, which in the current study will be 86. First we arrange the random numbers then in ascending order. The next column indicates the group to which participants belong, with the top half in Group A and the bottom half in Group B. For the next column is filled using the" Rand "function; this function generates random numbers for all individuals, so the individuals will be randomly ordered within each of the two groups. At the end they enter the study according to the order of referral and allocate a code to them. Random unit: individual Randomization Tool: Software, Blinding description: In this study, sham control group will be matched with ear acupressure group in terms of all confounding variables but the type of label used in sham control group will be without Vakaria seeds and the mother will not stimulate the points. In this way, the participant and data Analyzer will not know how the groups are assigned. For this purpose, a complete explanation of the interventions will be given to the participant before random allocation. N/A Breastfeeding. Intervention 1: The intervention group receives acupressure of Ear by Vakaria seed on the dominant auricular points that include Prolactin, Endocrine, Small intestine1, Shen men and Liver for three times a day and one minute each time during ten days and recessive ear points that include Mammary gland, Kidney and Sympathetic autonomic points receives acupressure with same method in dominant ear. The above points will be identified by the researcher and using the Pointer Excel 2 device. Intervention 2: The sham control group receives the intervention by application of label without Vakaria seeds and any stimulation in the same areas of the acupressure intervention group.The above points will be identified by the researcher and using the Pointer Excel 2 device. Yes - There is a plan to make this available What will be shared: Protocol and data files When: After publishing the article To whom: For Journal reviewers and the readers of the article if they need Conditions: If they asked Where to obtain: Midwifery and Reproductive Health Rese4arch Center Shahid Beheshti University of Medical Sciences How to obtain: email to researchers Comments:
public Fatemeh Khorasanian
First House on the left, 9th Alley, South Meraj Street
Rafsanjan Iran (Islamic Republic of) 7719656799 +98 34 3421 5205 Khorasanian.fatemeh7727@gmail.com Shahid Beheshti University of Medical Sciences scientific Masoumeh Simbar
Midwifery and Reproductive Health Research Center, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences , Vali-Asr Avenue, Cross of Vali-Asr and Neiaiesh Highway, Opposite to Rajaee Heart Hospital
Tehran Iran (Islamic Republic of) 1996835119 0098 21 888202512 msimbar@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Gestational age of 37-42 weeks Has objective and perceived criteria for breastfeeding inadequacy according to the checklist The mother has a normal body mass index (19.8-26 kg / m 2) Having the ability to write and read Live single fetus Baby weighing between 2.5 and 4 kg The infant has no low Apgar score, jaundice and congenital malformations The infants should have sucking and routing reflexes and complete neural development The mother should not have chorioamnionitis, preeclampsia and diabetes in the current pregnancy Mothers should not be addicted to drugs, psychotropic drugs or alcohol Mothers should not have Untreated Active Tuberculosis or Immunodeficiency Virus No known medical conditions such as Chronic systemic diseases and advanced cancer The woman should not have breast problems such as abscesses, nipple dislocations, and low or non-glandular tissue of the breast Mothers should not have ear piercings in the areas intended for acupressure 18 years 38 years Female Lack of desire of mothers to continue to participate in research Failure to perform acupressure as taught in three consecutive times The mother stops breastfeeding for any reason Signs of infection, bleeding, shock and convulsions after delivery Infant hospitalization in neonatal intensive care unit Use other methods to increase breastfeeding Any physical and mental illness that disrupts breastfeeding, such as liver disease, cancer, mammalian problems and Postpartum depression Treatment - Devices Placebo The intervention group receives acupressure of Ear by Vakaria seed on the dominant auricular points that include Prolactin, Endocrine, Small intestine1, Shen men and Liver for three times a day and one minute each time during ten days and recessive ear points that include Mammary gland, Kidney and Sympathetic autonomic points receives acupressure with same method in dominant ear. The above points will be identified by the researcher and using the Pointer Excel 2 device. The sham control group receives the intervention by application of label without Vakaria seeds and any stimulation in the same areas of the acupressure intervention group.The above points will be identified by the researcher and using the Pointer Excel 2 device. Maternal serum Prolactin. Timepoint: At the beginning of the study (before the intervention) and Tenth day after cesarean delivery (end of the study). Method of measurement: Prolactin Laboratory Kit. Baby weight gain. Timepoint: At the beginning of the study (before the intervention) and Tenth day after cesarean delivery (end of the study). Method of measurement: Digital scales for children. Breast volume. Timepoint: At the beginning of the study (before the intervention) and Tenth day after cesarean delivery (end of the intervention). Method of measurement: Height and radius of the breast will be measured by Caliper and placed in the volume formula. Sufficient breastfeeding. Timepoint: Tenth day after cesarean delivery(end of the intervention). Method of measurement: Sufficient breastfeeding questionnaire. Uterine recovery. Timepoint: Tenth day after cesarean delivery(end of the intervention). Method of measurement: Touch Uterine fundus from the abdomen. Shahid Beheshti University of Medical Sciences Approved 2021-04-27 Institutional Ethics Committee of the Faculty of Pharmacy and Nursing Midwifery of Shahid Beheshti U Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)