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Mothers of newborn infants before the time or in the right time hospitalized in neonatal ICU, under the use of natural intervention based on flowers: clinical research where neither the researcher nor the participant nor the statistician knows which group they belong to and the groups are made by lot

Mothers of premature and premature newborns hospitalized in a neonatal ICU, under intervention of Bach florals: clinical trial, triple blind, randomized

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7jtmpc
Enrollment
Unknown
Registered
2019-10-10
Start date
2019-06-17
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

Psychological stress

Interventions

The data collection will be done by the researcher and previously trained employees and will contemplate the following steps: In the first stage, 48-72 hours after delivery with 51 women for the inte
Other
E02.190

Sponsors

Universidade Federal de São Paulo
Lead Sponsor
Universidade Federal de São Paulo
Collaborator

Eligibility

Sex/Gender
Female
Age
0 Years to 0 Years

Inclusion criteria

Inclusion criteria: Puerperas older or younger than 18 years old with free and informed consent, for adults and or parents and guardians, and Term of Assent, for minors, with no age limit, single-gestation, whose premature born less than 37 weeks old, who are hospitalized at the Neonatal or Semi-Intensive Care Unit for at least 48 hours, who have visited the child at least once, do not present a contraindication to breastfeeding, and have started the expression of the milk in the first 24 hours of hospitalization, which exhibit some level of stress measured from the Parental Stress Scale: Neonatal Intensive Care Unit

Exclusion criteria

Exclusion criteria: Mothers of newborns who are breastfeeding directly in the mother, puerperal women using galactagogues and or anxiolytics and antidepressants, with mammary malformation or reduction or mammoplasty; foreigners, due to the difficulty of communication and cultural difference, drug users, who do not have a mobile phone.

Design outcomes

Primary

MeasureTime frame
Primary outcome variable Stress: It refers to the level of stress of the puerperas that will be evaluated in two ways: by the Parental Stress Scale: Neonatal Intensive Care Unit and by the hormonal dosage of cortisol There is no cut-off point (score) and the analysis will be done in terms of average because the objective will be to evaluate the reduction or not of the level of stress with the use of the Florals.

Secondary

MeasureTime frame
Secondary outcome variable Milk production: it will be analyzed by means of the volume of milk collected, obtained means of consulting the donor's file. The average volume obtained in the interval of 5 days, between the 7th. and 8th. day and between the 12th. and 13th day after delivery, after the second and third intervention. It is expected an increase of at least 10% increase in dairy production from the beginning to the end of the research for each woman.

Countries

Brazil

Contacts

Public ContactTatiana de Resende

Universidade Federal de São Paulo

tatibrazao@hotmail.com5534991979797

Outcome results

None listed

Source: REBEC (via WHO ICTRP)