Effect of Maternal Voice on Pain, Sedation, and Physiological Parameters in Mechanically Ventilated Children
The Effect of Maternal Voice Played to Children on Mechanical Ventilators on Pain, Sedation, and Physiological Parameters: A Randomized Controlled Trial
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This randomized controlled trial will be conducted in the Pediatric Intensive Care Unit (PICU) of Kayseri City Hospital. Eligible children (aged 1-3 years, intubated, mechanically ventilated, and sedated, with no change in sedation dose in the prior 24 hours) will be assigned to an intervention or control group using stratified block randomization (stratified by age, sex, diagnosis duration, and COMFORT scale score), with simple randomization within blocks performed by an independent researcher.
In the intervention group, each child's mother will be asked to read a children's storybook aloud in a quiet room, and this reading will be recorded (approximately 10 minutes). The recording will then be played to the child once, through wireless over-ear headphones at a safe volume (50-55 dB), during a single morning session. The COMFORT Scale and physiological parameters (heart rate, oxygen saturation, blood pressure, respiratory rate) will be assessed before, during, and after the recording is played. All sessions will be video recorded so that COMFORT Scale scores can also be scored by independent, blinded observers.
Children in the control group will receive standard unit care with no additional intervention, and will be assessed on the same schedule and with the same tools as the intervention group.
Data will be analyzed using IBM SPSS 27.0. Group comparisons will use Chi-square, Independent/Paired Samples t-tests, or Mann-Whitney U/Wilcoxon tests as appropriate, with statistical significance set at p < 0.05.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: GAMZE NUR GÜZEL, RN
- Número de telefone: +905535664246
- E-mail: gmznrgzl446@gmail.com
Locais de estudo
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Kayseri
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Kayseri, Kayseri, Turquia (Türkiye)
- Kayseri City Hospital
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Contato:
- GAMZE NUR GÜZEL, RN
- Número de telefone: +905535664246
- E-mail: gmznrgzl446@gmail.com
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Contato:
- MERAL BAYAT, PhD
- Número de telefone: +905336504292
- E-mail: mbayat@erciyes.edu.tr
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Children aged 1-3 years, intubated and mechanically ventilated under sedation
- No change in sedation dose within the last 24 hours
- No hearing impairment in the child
- Parent has no visual, hearing, or speech impairment
- Parent is a Turkish speaker/reader with at least a primary school education
- Parent provides written and verbal informed consent
Exclusion Criteria:
- Children receiving care/treatment due to surgical operation or trauma
- Children who experience cardiac arrest during the study
- Children whose parent withdraws consent during the study
- Children who are extubated during the study
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Maternal Voice Intervention Group
Children received a single ~10-minute recording of their mother's voice reading a children's storybook, played once through wireless over-ear headphones at 50-55 dB during a single morning session, with no other interventions during playback.
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A single ~10-minute audio recording of the child's own mother reading a children's storybook ("The Invisible String," Turkish edition) will be played once through wireless over-ear headphones at a safe listening level (50-55 dB), during a single morning session (10:00-12:00), with no other procedural interventions during playback. The recording will be made in a quiet room by an independent researcher using a digital audio recorder. Want to be notified when Claude responds? |
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Sem intervenção: Control Group
Children received standard PICU care with no additional intervention.
Assessments (COMFORT Scale, physiological parameters, video recording) were performed on the same schedule as the intervention group.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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COMFORT Scale
Prazo: Assessed before (~5 min), during (~10 min), and immediately after (~5 min) the intervention, within a single ~20-minute session on the day of enrollment
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The COMFORT Scale (full behavioral and physiological scale for assessing pain and sedation level in critically ill children) assesses eight items - alertness, calmness, respiratory response, physical movement, blood pressure, heart rate, muscle tone, and facial tension - each scored 1 to 5, yielding a total score ranging from 8 (minimum) to 40 (maximum).
Higher scores indicate greater distress/pain and inadequate sedation, while lower scores indicate deeper sedation and better comfort.
Scores will be compared between the maternal voice intervention group and the control group.
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Assessed before (~5 min), during (~10 min), and immediately after (~5 min) the intervention, within a single ~20-minute session on the day of enrollment
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: MERAL BAYAT, PhD, TC Erciyes University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2025/607
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