Authors
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University of São Paulo at Ribeirão Preto College of Nursing -More
Category
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Primary study
Registry of Trials»Brazilian Registry of Clinical Trials
Year
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2020
INTERVENTION: Acupuncture, Ear It is a controlled, randomized, with three parallel groups: intervention, placebo and control. Sociodemographic, obstetric and newborn data will be collected from an instrument organized for this purpose. The participant had received breastfeeding care and After the service,the group will be drawn and start follow‐up as randomized. The Three groups are : Auricular Acupuncture Group (true acupuncture group).The Auricular Acupuncture group will receive twice a week sessions of auricular acupuncture with a total of four sessions of intervention. The sessions will have an average duration of 10 minutes. Will be used a treatment protocol with the following auricular points:Shen Men; Sympathetic Autonomic; Kidney; Mammary gland, Endocrine, Prolactin, Tension point. The points were chosen based on scientific literature and clinical practice of the researchers. Placebo acupuncture "Sham acupuncture" ‐ Placebo Group. For this group we will use a simulation of the needles insertion by the touch of the tip of a toothpick, in the same points used for the real acupuncture group, followed by bonding with a hypoallergenic adhesive tape. Participants will be instructed to remain with the adhesive tapes for three‐four days, being taken off by the researcher at the next session. The application will be made unilaterally and each session ears will be alternated. Usual care:The control group will receive usual care, which consists of individualized care and guidance in breastfeeding. It will be held for the same period and frequency of the other interventions. Likewise, all groups will receive the usual care provided by the Human Milk Bank. During the follow‐up phase, data regarding breastfeeding will be collected through< Other CONDITION: Lactation disorders ; Lactation Disorders Lactation Disorders O00‐O99 PRIMARY OUTCOME: The duration of breastfeeding in days in women who received ear acupuncture is expected to be longer than the duration of breastfeeding for other women who are part of other groups. We will follow the recommendations based on CONSORT 2010 and will also be based on STRICTA. Will be calculated average values,standard deviation and median for quantitative variables. To test the null hypothesis, the ANOVA Analysis of Variance Test for repeated measures will be used. For the before and after within each group, the paired t‐student test will be performed. The effect size of the treatments will also be evaluated by the Cohen d index and the percentage of change, observing the average differences and the 95% Confidence Interval. The level of statistical significance to be used will be ? = 0.05. Statistical analyzes will be performed using the STATA software, 13.1.; ; ; ; INCLUSION CRITERIA: Lactating mothers between the fifth and 30th day postpartum; women who have insufficient milk production to the baby's demands, perception of the mother of low milk production; signs of dissatisfaction of the baby with breast milk; weight loss of the newborn; difficulties to gain weight; need to introduce milk formula as a form of supplement to breast milk. SECONDARY OUTCOME: It is expected that at least one of the breastfeeding averages is different in the three groups (acupuncture, placebo and usual care).We will follow the recommendations based on CONSORT 2010 and will also be based on STRICTA. Will be calculated average values,standard deviation and median for quantitative variables. To test the null hypothesis, the ANOVA Analysis of Variance Test for repeated measures will be used. For the before and after within each group, the paired t‐student test will be performed. The effect size of the treatments will also be evaluated by the Cohen d index and the percentage of change, observing the average differences and the 95% Confidence Interval. The level of statistical significance to be used will be ? = 0.05. Statistical analyzes will be performed using the STATA software, 13.1.
Epistemonikos ID: 4f58e1ba6dc8c214563eab7b18c719bbc7edb7d4
First added on: Aug 24, 2024