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Effectiveness of Breastfeeding in reducing Pain induced by the Pentavalent Vaccine in the second month: a randomized clinical trial

Effectiveness of Breastfeeding in reducing Pain induced by the Pentavalent Vaccine in the second month: a randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9vh37wr
Enrollment
Unknown
Registered
2022-11-04
Start date
2022-10-30
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

Vaccines

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
Lead Sponsor
Universidade Federal do Piauí - Campus Amílcar Ferreira Sobral
Collaborator

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

MeasureTime frame
It is expected to find a reduction in pain associated with the administration of the Pentavalent vaccine in 2-month-old infants, verified by the use of breastfeeding before and during the vaccination procedure, from the observation of a variation of at least 2.3 points in the measurements of pain between the intervention and control groups, assessed by the FLACC Scale.

Secondary

MeasureTime frame
Secondary outcomes are not expected.

Countries

Brazil

Contacts

Public ContactMaria Bezerra

Universidade Federal do Piauí

mariaaugusta@ufpi.edu.br+55 (89) 3522-2716

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 7, 2026