Anxiety
Conditions
Interventions
This is a controlled, triple-blind, randomized clinical trial with mothers of full-term newborns, which will be carried out at the Amparo Maternal Hospital and through home visits. The sample will con
Sponsors
Escola Paulista de Enfermagem
Universidade Federal de São Paulo
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Puerperal women over the age of 18 will be included; residents in the city of São Paulo/SP; who have a cell phone to contact, with a single fetus pregnancy; habitual risk, whose children were born alive, with a gestational age equal to or greater than 37 weeks and a newborn weighing equal to and/or greater than 2,500 grams, without complications, with criteria to maintain rooming-in and exclusive breastfeeding after delivery, who present any level of stress, anxiety or symptoms of depression, and who are in the period between 12 and 48 hours after delivery
Exclusion criteria
Exclusion criteria: The exclusion criteria were foreign puerperae; who declared themselves to be illiterate and/or cognitively impaired, regardless of their schooling; unable to read and understand the Informed Consent Form (ICF); with hearing and/or visual impairments; disoriented as to time, space and people; using galactagogues and/or anxiolytics and antidepressants; users of alcohol or illicit drugs; smokers using more than 10 cigarettes/day; with breast malformation or mammoplasty; diagnosed with gestational diabetes, hypothyroidism and/or hyperthyroidism, or any other endocrine disease; body mass index (BMI) equal to or greater than 30kg/m2 in the period prior to pregnancy or up to the first 8 weeks of pregnancy; NB requiring Neonatal Intensive Care Unit support for a period of more than 12 hours; diagnosed with short frenulum; with orofacial alterations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stress: This refers to the stress level of the puerperal women, assessed using the Perceived Stress Scale (PSS10). The scale has a maximum score of 40 points, and the higher the score, the greater the perceived stress ;Anxiety: This refers to the level of anxiety of the puerperal women, assessed using the Beck Anxiety Inventory (BAI). The scale has a maximum score of 63 points, with the following being considered: 0-7 points: minimal; 8-15 points: mild; 16-25 points: moderate and 26-63: severe;Depression: This refers to symptoms of postnatal depression assessed using the Edinburgh Postnatal Depression Scale (EPDS). The scale has a maximum score of 30 points and a score above 10 is considered a risk of depression | — |
Secondary
| Measure | Time frame |
|---|---|
| Milk production: refers to the signs and symptoms related to milk production identified in the puerperal woman. It will be assessed by means of Lactogenesis II or apojadura; Breast consistency: ; Breast volume; Women's perception of milk production; Alternation of breasts in the same feed; Approximate frequency of feeds over 24 hours; Behavior of the NB after feeds; Weight of the NB. | — |
Countries
Brazil
Contacts
Public ContactAna Cristina Abrão
Universidade Federal de São Paulo
Outcome results
None listed