Authors
»
Universidade Federal do Ceará - UFC -More
Category
»
Primary study
Registry of Trials»Brazilian Registry of Clinical Trials
Year
»
2020
INTERVENTION: Music Other 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 1, n = 13) and without music, for 15 minutes (Control Group 2, n = 13), hospitalized in the Joint Accommodation. For this study, priority was given to the evaluation of facial mimicry (using the Neonatal Facial Coding System scale, crying), as well as physiological heart rate measurement. The assessment of facial and physiological mimicry were performed at the Baseline moments (when term newborns were kept at rest before venipuncture), Pre‐procedure 1 (when the MP3 with music was turned on), Pre‐procedure 2 (vein search), Procedure (submitted to antisepsis, puncture, pressuring/aspirating blood and compression) and Recovery (rest of term newborn after the end of compression). The Neonatal Facial Coding System was coded by presence or absence and the duration was recorded as “presentâ€? (score 1) and “absentâ€? (score 0), continuously, from second to second, in the interval of the first 20 seconds of the Baseline moment. In Pre‐procedure 1 and Recovery moments, coding was performed for initial and final 20 seconds. In the Pre‐procedure 2 and Procedure moments, the coding was performed second by second, while the procedures lasted. As for Crying, it was considered as any audible vocalization that lasts longer than five seconds, with pause intervals of up to 20 seconds. It was timed continuously, second by second, similar to the Neonatal Facial Coding System, throughout the period of data collection for the Basal and Recovery moments. At Pre‐procedure 1, it was analyzed, second by second, in blocks of 20 seconds, for a total time of 2 minutes (initial and final). In the m CONDITION: Crying Crying; Infant newborn ; Crying ; Infant, Newborn Infant, Newborn PRIMARY OUTCOME: 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. 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. SECONDARY OUTCOME: 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). 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.
Epistemonikos ID: 453b64cccea814bddc962b77fa8481b4c67e1c4e
First added on: Aug 24, 2024