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Music in the pain of the term newborn undergoing venipuncture: Randomized Clinical Trial

Music in the pain of the term newborn undergoing venipuncture

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8x8v2r
Enrollment
Unknown
Registered
2020-03-27
Start date
2017-02-09
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

Crying

Interventions

The final sample consisted of 52 term newborns distributed as follows: music 10 minutes (Music Group 1, n = 13), music 15 minutes (Music Group 2, n = 13), without music, for 10 minutes (Control Group
Other

Sponsors

Universidade Federal do Ceará - UFC
Lead Sponsor
Hospital São Camilo Cura d'Ars
Collaborator

Eligibility

Age
0 Days to 2 Days

Inclusion criteria

Inclusion criteria: Newborns with clinical indication of venipuncture for blood test collection; newborn with birth gestational age equal or greater than 37 and smaller 42 weeks, considering the time of amenorrhea or ultrasound performed in the first trimester of pregnancy.When the data was not available, the New Ballard evaluation methods were considered;Newborn with score on the APGAR index bulletin equal or greater than 7 in the 5th minute of life; newborn who underwent Neonatal Hearing Screening.

Exclusion criteria

Exclusion criteria: Newborn using drugs that interfere with pain perception (nociception), such as opioid analgesics and other types of sedatives;newborn whose mother may be breastfeeding using medications that interfere with pain perception (nociception), such as opioid analgesics; newborns undergoing surgical procedures.

Design outcomes

Primary

MeasureTime frame
To assess whether there is difference in the behavioral and physiological pain response of term newborns, submitted to music intervention, in two extensions of time of 10 and 15 minutes, before, during and after, when compared to those term newborns without use of music.;The outcome actually observed at the end of the study was that term newborns who underwent the music group intervention 2, before, during and after venipuncture for blood collection, demonstrated a greater absence of facial pain reactions.

Secondary

MeasureTime frame
Decreased behavioral response (facial mimicry, crying) and physiological response (heart rate) in the newborn submitted to music intervention, in two time extensions of 10 and 15 minutes, before, during and after, when compared to those term newborn without using music. ;Music Group 2 showed a greater absence of facial mimicry (protruding forehead, narrowed eyes, deep nasolabial fold, open mouth horizontally, tense tongue), when compared to the other groups, at all times analyzed (p smaller 0.05). This evidence shows that the expression of pain was lower in Music Group 2. Crying was more present in antisepsis, puncture and pressuring / aspirating blood in the Music Group 1, Control Group 1 and Control Group 2, as well as in compression, in the Control Group 1 and Control Group 2. At the moment Pre-procedure 1 (initial) , in the Control Group 1, and at other times, in the Control Group 2, the newborns showed greater absence of crying (Pearson's Chi-Square Test), with p smaller 0.05. Music Group 2 showed average heart rate lower than the newborns of the other groups at the baseline moment until the time of Recovery, with statistical significance (p smaller 0.0001) at the baseline moment, Pre-procedure 1, Pre-procedure moment 2, Procedure moment (antisepsis, pressuring / aspirating blood) and Recovery moment (ANOVA).

Countries

Brazil

Contacts

Public ContactMaria ;Maria Vera Lúcia Cardoso;Cardoso

Universidade Federal do Ceará;Universidade Federal do Ceará - UFC

cardoso@ufc.br;cardoso@ufc.br+55 085 33668464;+55 085 33668464

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 18, 2026