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IRCT20230717058818N1 IRCT 2023-08-21 Ilam University of Medical Sciences Comparison of the effect of Entonex gas with Bl32 and sp6 pressure points on labor pain, labor stages and labor outcomes IEPS Comparison of the effect of Entonex gas with Bl32 and sp6 pressure points on labor pain, labor stages and labor outcomes in primiparous women 2023-08-11 anticipated 90 Complete https://irct.ir/trial/71445 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After receiving written consent, 90 patients will be randomly divided into three groups: Entonex, acupressure, and control, so that there will be 30 people in each group. Balance block randomization method will be used for random and the stata software allocation of people and the ralloc package will be used to create a random sequence. .In this way, 6 blocks with 1 permutation will be created in the following order: 1=ABC 2=ACB 3=CAB 4=CBA 5=BCA 6=BAC Where A represents the Entonex group, B represents the acupressure group and C represents the control group. Then, based on the numbers in the random table, a number will be chosen randomly, and based on the last digit on the right, one of the groups will be used to determine the sequence of randomization. It should be noted that if the number on the right is zero or 7 to 9 when choosing a random number, that number will not be considered and a random number will be selected again. This will continue until all 90 people are assigned to three groups. It should be noted that this method will prevent two groups from being unbalanced, as well as identifying the randomization sequence. N/A Labor duration, labor pain and maternal and fetal complications after delivery. Intervention 1: Intervention group: entonex.Until the client learns how to use the Entonx mask and capsule and identify uterine contractions, the training will continue, and Entonx gas with a mask will be used as self-prescription from the beginning to the end of each uterine contraction. Intervention 2: Intervention group: point pressures.Acupressure will be performed at BL32 and SP6 points, and pressure will be applied during uterine contractions by two hands of the researcher on both sides. After 30 seconds of pressure, a 30-second rest will be given. In this way, it will continue for 20 minutes, and each time One of these two points is pressed bilaterally, and the instructor will stay with the researcher until the complete training on how to perform acupressure. Intervention 3: Control group: control.The control group received only routine measures. Yes - There is a plan to make this available What will be shared: Clinical study report, results are shared When: Access starts one year after the results are published To whom: Researchers working in academic institutions Conditions: Analytical studies Where to obtain: gheitasi-s@medilam.ac.ir Shaghayegh Gheitasiilami How to obtain: Information will be sent after the request is reviewed and if the ethical points of the research and the consent of the participants are met. Comments:
public Shaghayegh Gheitasiilami
No.5,Resalat Ave,Rasalat Street,Ilam Town
Ilam Iran (Islamic Republic of) 6831956599 +98 84 3333 3333 gheitasi-s@medilam.ac.ir Ilam University of Medical Sciences scientific Shaghayegh Gheitasiilami
No.5,Resalat Ave,Resalat Street,Ilam Town
Ilam Iran (Islamic Republic of) 6931956599 +98 84 3333 3333 gheitasi-s@medilam.ac.ir Ilam University of Medical Sciences Iran (Islamic Republic of) Consent to participate in the study Having literacy Singleton pregnancy Gestational age 37 to 41 weeks Fetal cephalic status Women being in the active phase Not suffering from mental disorders No Anatomical disorders Not using other methods of anesthesia Not using oxytocin to induce and strengthen labor 18 years 35 years Female Multiple pregnancy Mother's chronic illness Skin diseases such as eczema high risk pregnancy Rehabilitation Rehabilitation Rehabilitation Intervention group: entonex.Until the client learns how to use the Entonx mask and capsule and identify uterine contractions, the training will continue, and Entonx gas with a mask will be used as self-prescription from the beginning to the end of each uterine contraction. Intervention group: point pressures.Acupressure will be performed at BL32 and SP6 points, and pressure will be applied during uterine contractions by two hands of the researcher on both sides. After 30 seconds of pressure, a 30-second rest will be given. In this way, it will continue for 20 minutes, and each time One of these two points is pressed bilaterally, and the instructor will stay with the researcher until the complete training on how to perform acupressure. Control group: control.The control group received only routine measures. Labor progress. Timepoint: 4 cm dilatation, every one hour during intervention and after delivery. Method of measurement: Checklist of Duration of Labor Stages. Labor pain. Timepoint: one hour during labor. Method of measurement: Ten Degree Visual Analogue scale. Maternal and Neonatal Outcomes. Timepoint: After giving birth and the day after giving birth. Method of measurement: Checklist of Maternal and Neonatal Outcomes. Maternal and neonatal complications after delivery. Timepoint: Before birth and one day after delivery. Method of measurement: Checklist of maternal and newborn outcomes designed by the researcher. Ilam University of Medical Sciences Approved 2023-06-14 Ethics committee of Ilam University of Medical Sciences No.5.Resalat Ave,resalat street,Ilam Town Ilam Ilam Iran (Islamic Republic of)