Vaccines
Conditions
Interventions
Infants allocated to Intervention Group 1 (IG1) will undergo the breastfeeding process before vaccination. Mothers will be asked, still in the private room and in a comfortable chair, to breastfeed th
2. Mouth wide open
3. Lower lip turned out
4. Chin touching breast. Swallowing (visible and/or audible) will also be identified (BRASIL, 2015). Then, mothers will be instructed to stop breastfeeding during the entire vaccination procedure.
Inf
Sponsors
Universidade Federal do Piauí - Campus Amílcar Ferreira Sobral
Universidade Federal do Piauí - Campus Amílcar Ferreira Sobral
Eligibility
Age
60 Days to 89 Days
Inclusion criteria
Inclusion criteria: Infants aged between 60 and 89 days; who are breastfed; who were born with a gestational age of 37-42 weeks; no visible and/or reported congenital malformations by the mother; in need of Pentavalent vaccination.
Exclusion criteria
Exclusion criteria: Infants who are not breastfed directly from the breast; who have used analgesics in the last 48 hours before vaccination; who are agitated before vaccination; who have a history of hypersensitivity to any component of the immunobiological and/or other contraindications established by the Ministry of Health (BRASIL, 2016); or develop an allergic reaction such as a rash to the vaccine given.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected Outcome 1: A reduction in pain associated with the administration of the Pentavalent vaccine in 2-month-old infants is expected, achieved through breastfeeding before and during the vaccination procedure. This effect will be evidenced by a difference of at least 2.3 points in pain scores between the intervention and control groups, as measured by the Face, Legs, Activity, Cry, and Consolability (FLACC) Scale.;Observed Outcome 1: A reduction in pain during the administration of the Pentavalent vaccine in infants was observed, as assessed by the Face, Legs, Activity, Cry, and Consolability (FLACC) Scale, with lower mean pain scores in the intervention groups: 6.06±1.25 in the group breastfed only before vaccination and 3.83±1.23 in the group breastfed before and during vaccination, compared to the control group (7.43±1.30). A statistically significant difference was found for the group breastfed before and during vaccination (p < 0.001), indicating greater effectiveness of this strategy in reducing pain. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected Outcome 2: No secondary outcomes are expected.;Observed Outcome 2: The most effective breastfeeding interval for promoting an antinociceptive effect in infants was identified as breastfeeding performed five minutes before and during vaccination. This was demonstrated by comparisons between groups, showing a lower mean pain score on the Face, Legs, Activity, Cry, and Consolability (FLACC) Scale (3.83±1.23) compared to breastfeeding only before vaccination (6.06±1.25) and the control group (7.43±1.30), with a statistically significant difference (p < 0.001), indicating greater effectiveness of the intervention with longer exposure time. | — |
Countries
BR
Contacts
Public ContactMaria Bezerra
Universidade Federal do Piauí
Outcome results
None listed