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Use of ear acupuncture to help maintain breastfeeding until 6 months of age.

The effectiveness of auricular acupuncture in the duration of exclusive and complementary breastfeeding: a randomized clinical trial”.

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
REBEC
Registry ID
RBR-8z2z82
Enrollment
Unknown
Registered
2020-05-12
Start date
2017-02-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lactation disorders

Interventions

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 pur
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 Gr
Other
E02.190.044.133

Sponsors

University of São Paulo at Ribeirão Preto College of Nursing
Lead Sponsor
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: To make use of galactogogues drugs during the research period;Being a smoker; history of breast surgery (breast reduction surgery or breast implant); never had made the auricular acupuncture before;pregnancy and delivery with any complications; baby who have an weight smaller than 2.500g and larger than 4.000g; twin pregnancy;preterm birth;be allergic to any materials used in auricular acupuncture; make use of other energy therapies (herbal treatments, Reiki, Flower therapy, homeopathy, etc);the patient has no time available to do the treatment;do not have a telephone.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Brazil

Contacts

Public ContactJuliana;Juliana Cafer;Cafer

Escola de Enfermagem de Ribeirão Preto USP;Escola de Enfermagem de Ribeirão Preto USP

juliana.cafer@usp.br;juliana.cafer@usp.br+55 16 3315-3381;+55 16 3315-3381

Outcome results

None listed

Source: REBEC (via WHO ICTRP)