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Lullaby in reducing pain in newborns

Lullaby in reducing pain associated with heel puncture in neonatal biological screening: randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3h38cww
Enrollment
Unknown
Registered
2023-11-21
Start date
2022-09-01
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

Screening

Interventions

Newborns allocated to Intervention Group 1 (GI1) will hear a lullaby sung by their mother: mothers will be instructed on the appropriate songs to calm the baby, which should be simple, with soft rhyth
E02.190.888.500

Sponsors

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

Eligibility

Age
3 Days to 28 Days

Inclusion criteria

Inclusion criteria: Newborns with gestational age (GA) = 37 weeks; age from three to 28 days; birth weight = 2,500 g, considering that full-term babies have a different perception of pain than preterm newborns

Exclusion criteria

Exclusion criteria: Newborns who are receiving antibiotics, steroids or analgesics (up to 3 hours before the interventions); sick from any cause; neonates with medical instability; and NB accompanied by caregivers other than the mother. Finally, discontinuity criteria will be: NB who receive heel puncture twice due to an unsuccessful first procedure

Design outcomes

Primary

MeasureTime frame
It is expected to find a reduction in pain associated with heel puncture, performed during the Neonatal Biological Screening, verified by the use of music therapy (lullaby sung by the mother) from the verification of a variation of at least 2.0 points in the measurements of pain between the intervention and control groups, assessed by the NIPS Scale

Secondary

MeasureTime frame
No secondary outcomes are expected

Countries

Brazil

Contacts

Public ContactMaria Bezerra

Universidade Federal do Piauí

mariaaugusta@ufpi.edu.br+55-89-35222716

Outcome results

None listed

Source: REBEC (via WHO ICTRP)