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Study aim
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Determine the effect of intracutaneous and subcutaneous injection of distilled sterilized water on the severity of pain and the duration of the active phase of the first stage of labor in primipara women
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Design
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The clinical trial included two intervention groups and two control groups، with parallel groups,triple blind, randomized trials, randomized using cards with numbers from 1 to 4, design of 164 sample, sampling from 05/05/2013 to 23/09/2014
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Settings and conduct
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Based on the inclusion criteria and obtaining a written consent of the samples about how to do the study, information about pain intensity at 5 minutes before injection and 30, 60, 90, 120, 150, 180 minutes after injection, duration of the active phase of the first stage of labor, duration of the second stage of labor, delivery type, delivery satisfaction, perineum status, type and degree of rupture through the examination and interviews were collected. The severity of pain was measured by McGill's visual analogue scale pain.
In order to randomize, the cards are prepared and four numbers 1, 2, 3, and 4 are written and placed inside the packets in an unspecified manner and research unit remove one of the envelopes, if there is a number 1 in the group of intracutaneous of injection distilled sterilized water, number 2 subcutaneous injection of distilled sterilized water, number 3 in the group intracutaneous of injection normal saline and number 4 in the subcutaneous group of injection normal saline are placed.In groups 1 and 3, at each point Michael 's rhomboid 0.15 cc and in groups 2 and 4, at each point a 0.5 ml distilled sterilized water or normal saline was injected. Injection is performed in each of the four groups at intervals between contractions in the sitting position by insulin syringe.
In order to blind the study the assessor from the group assigned to the samples is not aware.The researcher does not know from the group assigned to the specimens.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Pregnant women aged between 18 and 35 years old, prmiparous women, Gestational age between full 37-41 weeks, singleton pregnancy; non-compliance criterion: All high risk pregnant women (preeclampsia, diabetes, oligo-hydramonious, polyhydramnious, etc.), using any pharmacological or non-pharmacological method to reduce pain in the course of labor
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Intervention groups
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Intracutaneous injection of distilled sterilized water, subcutaneous injection of distilled sterilized water, intracutaneous injection of normal saline, subcutaneous injection of normal saline
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Main outcome variables
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The main consequences include the severity of labor pain; duration of the active phase of the first stage of labor; duration of the second stage of labor; type of delivery; satisfaction of delivery