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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: GAMZE NUR GÜZEL, RN
- Número de teléfono: +905535664246
- Correo electrónico: gmznrgzl446@gmail.com
Ubicaciones de estudio
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Kayseri
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Kayseri, Kayseri, Turquía (Türkiye)
- Kayseri City Hospital
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Contacto:
- GAMZE NUR GÜZEL, RN
- Número de teléfono: +905535664246
- Correo electrónico: gmznrgzl446@gmail.com
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Contacto:
- MERAL BAYAT, PhD
- Número de teléfono: +905336504292
- Correo electrónico: mbayat@erciyes.edu.tr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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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Sin intervención: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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COMFORT Scale
Periodo de tiempo: 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
- Silla de estudio: MERAL BAYAT, PhD, TC Erciyes University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2025/607
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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