Effect of Multisensory Stimulation on Pain During Heel Lance in Newborns
31 de julio de 2026 actualizado por: Ilcim Ercan Koyuncu, Baskent University
The Effect of Multisensory Stimulation Applied During Heel Blood Sampling on Pain and Physiological Parameters in Newborns: A Randomized Controlled Trial
This randomized controlled study will evaluate whether multisensory stimulation can reduce pain in healthy newborns during heel blood sampling.
Newborns will be assigned to either a multisensory stimulation group, which includes breastfeeding, gentle stroking, maternal singing, and eye contact, or a control group in which the procedure will be performed while the newborn is held in the mother's arms.
Pain scores, crying duration, heart rate, oxygen saturation, and procedure duration will be compared between the groups.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
Heel blood sampling is a routine procedure used in newborn screening; however, it can produce pain, crying, and short-term changes in physiological parameters such as heart rate and oxygen saturation. Non-pharmacological approaches are commonly used to reduce procedural pain in newborns, but the effects of individual methods may be inconsistent. Multisensory stimulation combines several familiar and comforting sensory inputs and may reduce pain by directing attention away from the procedure, supporting autonomic regulation, and decreasing the stress response.
In this study, multisensory stimulation will consist of breastfeeding, gentle stroking of the leg, maternal singing or lullaby, and continuous eye contact between the mother and newborn. Breastfeeding and gentle stroking will begin 10 minutes before heel blood sampling and continue until 5 minutes after the procedure. Maternal singing and eye contact will be maintained throughout the procedure. The control condition will reflect supportive routine care, with the newborn held in the mother's arms during heel blood sampling.
The study will examine whether this structured multisensory approach reduces procedural pain and crying and supports physiological stability in healthy newborns. Pain, heart rate, and oxygen saturation will be assessed before, during, and after heel blood sampling. Crying duration and total procedure duration will also be recorded. The findings may contribute to the development of a safe, practical, and standardized non-pharmacological approach to pain management during routine newborn procedures.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
72
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: İlçim Ercan-Koyuncu, PhD
- Número de teléfono: +905534700629
- Correo electrónico: ilcimercan@hotmail.com
Ubicaciones de estudio
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Beşevler
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Ankara, Beşevler, Turquía (Türkiye), 60300
- Reclutamiento
- Tatvan State Hospital
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Contacto:
- İlçim Ercan-Koyuncu
- Número de teléfono: 05534700629
- Correo electrónico: ilcimercan@hotmail.com
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Bitlis
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Bitlis, Bitlis, Turquía (Türkiye), 60300
- Reclutamiento
- Bitlis State Hospita
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Contacto:
- İlçim Ercan-Koyuncu
- Número de teléfono: 05534700629
- Correo electrónico: ilcimercan@hotmail.com
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Healthy newborns aged 0-28 days
- Newborns receiving routine monitoring and care with their mothers in the hospital's newborn care unit
- Written informed consent provided by the newborn's parent or legal representative
Exclusion Criteria:
- Presence of any lower-extremity anomaly
- Ongoing monitoring or treatment in the neonatal intensive care unit
- Presence of a congenital disease
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Multisensory Stimulation Group
Newborns assigned to this arm will receive a structured multisensory stimulation intervention during heel blood sampling.
The intervention will include breastfeeding, gentle stroking of the leg, maternal singing or lullaby, and continuous eye contact between the mother and newborn.
Breastfeeding and gentle stroking will begin 10 minutes before the procedure and continue until 5 minutes after the procedure.
Maternal singing and eye contact will be maintained throughout heel blood sampling.
|
The multisensory stimulation intervention consists of four components: breastfeeding, gentle stroking, maternal singing or lullaby, and eye contact.
Breastfeeding will begin 10 minutes before heel blood sampling and continue until 5 minutes after the procedure.
During the same 15-minute period, the mother will gently stroke the newborn's leg from which the heel blood sample will be obtained.
Throughout the heel blood sampling procedure, the mother will sing a lullaby or song in a soft and calm voice and maintain continuous eye contact with the newborn.
No standardized song or lullaby will be prescribed, and the sound level will remain within the range of natural mother-newborn communication.
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Sin intervención: Mother's Arms Control Group
Newborns assigned to this arm will receive routine heel blood sampling while being held in their mother's arms.
No additional structured non-pharmacological pain-reduction intervention will be administered.
When necessary, the mother may gently hold and support the newborn in a comfortable position during the procedure.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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N-PASS Pain Score
Periodo de tiempo: Immediately before, during, and immediately after heel blood sampling.
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Newborn pain will be assessed using the Neonatal Pain, Agitation and Sedation Scale (N-PASS).
The scale evaluates crying or irritability, behavioral state, facial expression, extremity tone or body tension, and changes in vital signs.
Higher pain scores indicate greater pain or agitation.
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Immediately before, during, and immediately after heel blood sampling.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Crying Duration
Periodo de tiempo: During the heel blood sampling session.
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The total duration of crying associated with heel blood sampling will be measured using a stopwatch and recorded in seconds.
A shorter crying duration indicates a more favorable outcome.
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During the heel blood sampling session.
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Heart Rate
Periodo de tiempo: Immediately before, during, and immediately after heel blood sampling.
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Heart rate will be measured non-invasively using a bedside pulse oximeter and recorded as beats per minute.
Heart rate values will be assessed to determine physiological responses to heel blood sampling and the multisensory stimulation intervention.
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Immediately before, during, and immediately after heel blood sampling.
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Oxygen Saturation
Periodo de tiempo: Immediately before, during, and immediately after heel blood sampling.
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Peripheral oxygen saturation will be measured non-invasively using a bedside pulse oximeter and recorded as a percentage.
Higher and more stable oxygen saturation values indicate a more favorable physiological response.
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Immediately before, during, and immediately after heel blood sampling.
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Procedure Duration
Periodo de tiempo: During a single heel blood sampling procedure
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The total duration of the heel blood sampling procedure will be measured using a stopwatch and recorded in seconds.
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During a single heel blood sampling procedure
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Garcia-Valdivieso I, Yanez-Araque B, Moncunill-Martinez E, Bocos-Reglero MJ, Gomez-Cantarino S. Effect of Non-Pharmacological Methods in the Reduction of Neonatal Pain: Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2023 Feb 12;20(4):3226. doi: 10.3390/ijerph20043226.
- Jin L, Zhang J, Yang X, Rong H. Maternal voice reduces procedural pain in neonates: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2023 Mar 24;102(12):e33060. doi: 10.1097/MD.0000000000033060.
- Sahin K, Yildiz S, Gur E. The effect of multi-sensory stimuli used during vaccination on pain and physiological parameters in infants: A randomized controlled trial. J Pediatr Nurs. 2026 Mar-Apr;87:20-30. doi: 10.1016/j.pedn.2025.11.051. Epub 2026 Jan 6.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de abril de 2026
Finalización primaria (Estimado)
15 de agosto de 2026
Finalización del estudio (Estimado)
15 de agosto de 2026
Fechas de registro del estudio
Enviado por primera vez
31 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
31 de julio de 2026
Publicado por primera vez (Actual)
5 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
31 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MSS-HEEL-RCT-2026-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .