RBR-7jt6zny Impact of Music in childhood

Date of registration: 06/05/2023 ^(mm/dd/yyyy)
Last approval date : 06/05/2023 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1288-5357

• Public title:

  en

  Impact of Music in childhood

  pt-br

  O impacto da Música no desenvolvimento infantil

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 64574322.3.0000.5417
    Issuing authority: Plataforma Brasil
  • 5.780.706
    Issuing authority: Comitê de Ética em Pesquisa da Faculdade de Odontologia de Bauru da Universidade de São Paulo

Sponsors

• Primary sponsor: Faculdade de Odontologia de Bauru da Universidade de São Paulo
• Secondary sponsor:
  • Institution: Bravo Academia de Música
• Supporting source:
  • Institution: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior

Health conditions

• Health conditions:

  en

  Child Development; Electrophysiology; Hearing; Music

  pt-br

  Desenvolvimento infantil; Eletrofisiologia; Audição; Música

• General descriptors for health conditions:

  en

  F03.625.164 Child Development Disorders, Pervasive

  pt-br

  F03.625.164 Transtornos globais do desenvolvimento infantil

• Specific descriptors:

  en

  F01.525.200 Child Development

  pt-br

  F01.525.200 Desenvolvimento infantil

  en

  H01.158.344.528 Electrophysiology

  pt-br

  H01.158.344.528 Eletrofisiologia

  en

  F02.830.816.263 Hearing

  pt-br

  F02.830.816.263 Audição

  en

  K01.602 Music

  pt-br

  K01.602 Música

Interventions

• Interventions:

  en

  This is a randomized controlled clinical trial, three-arm, blind,. Experimental group (G1): 20 full-term children with a minimum age of 180 days and a maximum of 209 days of life, with normal hearing will participate in a musical intervention based on the Music Learning Theory (MLT), for five months, once a week, totaling 20 classes of 45 minutes each. Positive control group (G2): 20 born at term children with a minimum age of 180 days and a maximum of 209 days of life, with normal hearing, will participate in a musical intervention without a defined methodology, but which will provide musical experience, also for five months, once a week, totaling 20 classes of 45 minutes each. Negative control group (G3): 20 full-term children with a minimum age of 180 days and a maximum of 209 days of life, with normal hearing who will have social exposure to music, which is a common condition for all groups, within a period of five months. The presentation of the project and clarification of any doubts to the mother or guardian will be carried out by one of the study researchers (P1), who will not participate in the intervention and data collection process. After accepting to participate in the research, with express agreement to carry out the evaluation and intervention procedures, by signing the Free and Informed Consent Term (ICF), the sample will be randomly allocated. For the randomization of the sample, the software Microsoft Office Excel, version 16.60 will be used. The numbering from 1 to 60 will be inserted in the worksheet, and the random distribution of numbers in groups G1, G2 and G3 will be performed using the "random between" function. The numbers belonging to each group will be placed in equal, opaque, sealed and mixed envelopes. The mother or guardian will be invited to choose an envelope that will define the group in which the child will be allocated. For the masking of the children's allocation sequence, the delivery of sealed envelopes, with the randomized numbers, will be made by Researcher 1, without the presence of the other researchers.

  pt-br

  Trata-se de um estudo clínico randomizado controlado de três braços, cego. Grupo experimental (G1): 20 crianças com idade mínima de 180 dias e máxima de 209 dias de vida, nascidas à termo, normo-ouvintes participarão de intervenção musical baseada na Music Learning Theory (MLT), durante cinco meses, uma vez por semana, totalizando 20 aulas de 45 minutos cada. Grupo controle positivo (G2): 20 crianças com idade mínima de 180 dias e máxima de 209 dias de vida, nascidas à termo, normo-ouvintes participarão de intervenção musical sem metodologia definida, mas que propiciará a vivência musical, também durante cinco meses, uma vez por semana, totalizando 20 aulas de 45 minutos cada. Grupo controle negativo (G3): 20 crianças com idade mínima de 180 dias e máxima de 209 dias de vida, nascidas à termo, normo-ouvintes que terão exposição social à música, que é uma condição comum para todos os grupos, no período de cinco meses. A apresentação do projeto e esclarecimentos de quaisquer dúvidas à mãe ou responsável será realizada por um dos pesquisadores do estudo, que não participará do processo de intervenção e coleta de dados. Após o aceite em participar da pesquisa, com concordância expressa para a realização dos procedimentos de avaliação e intervenção, mediante assinatura do Termo de Consentimento Livre e Esclarecido (TCLE), será efetuada a alocação randomizada da casuística. Para a randomização da casuística será utilizado o programa Microsoft Office Excel, versão 16.60. Na planilha será inserida a numeração de 1 a 60, e a distribuição randomizada dos números nos grupos G1, G2 e G3 será realizada por meio da função "aleatórioentre". Os números pertencentes a cada grupo serão colocados em envelopes iguais, opacos, lacrados e misturados. A mãe ou o responsável será convidado a escolher um envelope que definirá o grupo em que a criança será alocada. Para o mascaramento da sequência de alocação das crianças, a entrega dos envelopes lacrados, com os números randomizados, será feita pelo pesquisador responsável, sem a presença dos demais pesquisadores.

• Descriptors:

  en

  E02.190.888.500 Music Therapy

  pt-br

  E02.190.888.500 Musicoterapia

Recruitment

• Study status: Not yet recruiting
• Countries
  • Brazil
• Date first enrollment: 06/19/2023 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  60	-	180 D	209 D

• Inclusion criteria:

  en

  Children with a minimum age of 180 days and maximum age of 209 days of life at the pre-intervention time; of both genders; Term born with no history of risk factor for developmental delays; parents and first-degree relatives who are not music professionals; result passes neonatal hearing screening; brainstem auditory evoked potential with presence of wave V at 30 dBnHL at the pre-intervention moment; parents or guardians have not been exposed to the formal musical approach during the gestation period

  pt-br

  Crianças com idade mínima de 180 dias e máxima de 209 dias de vida no momento pré-intervenção; de ambos os sexos; nascidas a termo sem histórico de fator de risco para atrasos no desenvolvimento; pais e familiares de primeiro grau que não sejam profissionais da área da música; resultado passa na triagem auditiva neonatal; potencial evocado auditivo de tronco encefálico com presença de onda V em 30 dBnNA no momento pré-intervenção; mães que não tenham sido expostas à abordagem musical formal durante o período de gestação

• Exclusion criteria:

  en

  Children who present failure in neonatal hearing screening; history of disease in the first six months of life; neurological alterations; motor impairment and syndromes; external, middle and/or inner ear malformations

  pt-br

  Serão excluídas as crianças que apresentarem resultado falha na triagem auditiva neonatal; histórico de doenças nos primeiros seis meses de vida; alterações neurológicas; comprometimento motor; síndromes; malformações de orelha externa, média e/ou interna

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Prevention	Parallel	3	Single-blind	Randomized-controlled	N/A

Outcomes

• Primary outcomes:

  en

  The raw scores of the child development scale that will be converted into scaled scores and analyzed according to percentiles and confidence intervals (90% and 95%).

  pt-br

  Os escores brutos da escala de desenvolvimento infantil que serão convertidos em escores escalonados e analisados de acordo com os percentis e intervalos de confiança (90% e 95%).

• Secondary outcomes:

  en

  The absolute latencies (milliseconds) and amplitudes (microvolts) of components P1, N1, P2 and N2 found in the evaluation of Cortical Auditory Evoked Potentials (CAEP).

  pt-br

  As latências absolutas (milissegundos) e amplitudes (microvolts) dos componentes P1, N1, P2 e N2 encontradas na avaliação dos Potenciais Evocados Auditivos Corticais (PEAC).

Data Sharing Plan

• Data Sharing Plan:

  en

  Yes

• Data Sharing Description:

  en

  As the research involves human beings, it is necessary to sign the free and informed consent form by those responsible. It should be noted that the consent form will contain authorization for sharing data in a repository and reuse in other research, with anonymization. The storage will be carried out during the research in the Data Repository of the University of São Paulo https://uspdigital.usp.br/repositorio/, with sufficient storage of 2GB of space. Two backups will be made weekly. One stored in Institutional Cloud Services of the University of São Paulo and the other in institutional external storage devices (external HD). Access to data during research will be restricted to research members, with sharing restricted to "reading", and data will be entered only by the responsible researcher. To this end, the recommendations of ISO 27001 for Information Security Management will be complied with. When considering the reuse potential and the economic viability foreseen in the plan, all data will be kept and shared for a period of 5 years. We anticipate the reuse of data to validate the results of this research and conduct new studies with similar methodology. There is a forecast period of embargo until the publication of the first article that includes the main data of the research, with a forecast of 12 months after the end of the research. The CC-BY-NC - Creative Commons Attribution-NonCommercial license will apply for data reuse. Considering that there is no sensitive data and there will be anonymization of the data, no additional restriction is foreseen on the sharing of data, only those in line with the license. The research foresees the sharing of data in a reliable repository of the University of São Paulo, within one year after the conclusion of the research, with the generation of a persistent identifier. The data will be shared in open access, as long as the foreseen use license is respected. Potential users can discover research data by searching directly in the data repository, using the controlled language agreed in health sciences descriptors. The time and effort to prepare the data for sharing/preservation was factored into the lead researcher's work plan. Numeric type data will be collected. For Cortical Auditory Evoked Potentials (CAEP), the raw files generated by Curry 7 will be exported in .dap extensions; .dat; .rs3 and with the .html file generated by Stim 2. In addition, the .csv data will be extracted for analysis in statistical software. Regarding the Bayley III Scale, video files will be generated for each child, in .mp4 format, with a record of the application of the scale in the pre- and post-intervention moments. Researcher P4 who will apply the scale will edit the beginning and end of the recording. Thus, the file will start exactly with the testing of the first item of the scale and will be closed upon completion of the last item applied by the researcher. The duration of each video will vary, considering that it will depend on the execution of the items by the children, however, the duration is estimated at around 60 minutes. In the video analysis stage by three independent evaluators, based on the Scale registration form, each evaluator will separately score the child's performance in the Microsoft Office Excel program, version 16.60, in a spreadsheet created for the present study, and also saved in Comma-separated values(.csv) format. The approximate volume of collected data will be less than 1GB. Data will be accompanied by generic Metadata, including authors and title; Project-specific Metadata: General Data Spreadsheet (.csv): date of birth; age; sex; group identification (G1, G2, G3); Assessment data sheet (.csv): Bayley III scale in the pre-intervention moment: motor scale score, cognitive scale score, language scale score - receptive communication subtest and expressive communication subtest; Bayley III scale in post-intervention moment: motor scale score, cognitive scale score, language scale score - receptive communication subtest and expressive communication subtest; PEAC pre-intervention: latency (milliseconds) and amplitude (microvolts) values of components P1, N1, P2 and N2; CAEP post-intervention: latency (milliseconds) and amplitude (microvolts) values of P1, N1, P2 and N2; As additional documents will be included: data dictionary (dictionary.txt) and glossary (glossary.txt).

Contacts

• Public contact
  • Full name: Katia de Freitas Alvarenga
  • • Address: Departamento de Fonoaudiologia, Faculdade de Odontologia de Bauru – FOB, Universidade de São Paulo, Campus Bauru. Alameda Dr. Octávio Pinheiro Brisolla, Quadra 9-75 – Vila Universitária
    • City: Bauru / Brazil
    • Zip code: 17012-901
  • Phone: +55 (014) 997085671
  • Email: katialv@fob.usp.br
  • Affiliation: Faculdade de Odontologia de Bauru
   
• Scientific contact
  • Full name: Katia de Freitas Alvarenga
  • • Address: Departamento de Fonoaudiologia, Faculdade de Odontologia de Bauru – FOB, Universidade de São Paulo, Campus Bauru. Alameda Dr. Octávio Pinheiro Brisolla, Quadra 9-75 – Vila Universitária
    • City: Bauru / Brazil
    • Zip code: 17012-901
  • Phone: +55 (014) 997085671
  • Email: katialv@fob.usp.br
  • Affiliation: Faculdade de Odontologia de Bauru
   
• Site contact
  • Full name: Katia de Freitas Alvarenga
  • • Address: Departamento de Fonoaudiologia, Faculdade de Odontologia de Bauru – FOB, Universidade de São Paulo, Campus Bauru. Alameda Dr. Octávio Pinheiro Brisolla, Quadra 9-75 – Vila Universitária
    • City: Bauru / Brazil
    • Zip code: 17012-901
  • Phone: +55 (014) 997085671
  • Email: katialv@fob.usp.br
  • Affiliation: Faculdade de Odontologia de Bauru
   

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