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The Effect of Breast Milk Odor and Swaddling on Physiological Parameters and Stress Levels in Premature Infants Receiving Ventilator Support

1 de julio de 2026 actualizado por: Hediye Karakoç, KTO Karatay University

The Effect of the Safe Swaddling Method and the Scent of Breast Milk on Physiological Parameters, Stress, and Comfort Levels in Premature Newborns Receiving Mechanical Ventilator Support: A Randomized Controlled Study

It will be done to shorten the hospital stay of the newborn and increase the quality of care by proving the positive effect of the safe wrapping method and the smell of breast milk on the physiological parameters and stress level of the newborn in premature newborns receiving mechanical ventilator support.

  1. Safe wrapping method positively affects physiological parameters in premature newborns receiving mechanical ventilation support.
  2. Safe wrapping method reduces stress in premature newborns receiving mechanical ventilation support.
  3. Safe wrapping method increases comfort in premature newborns receiving mechanical ventilation support.
  4. The smell of breast milk positively affects physiological parameters in premature newborns receiving mechanical ventilation support.
  5. The smell of breast milk reduces stress in premature newborns receiving mechanical ventilation support.
  6. The smell of breast milk increases comfort in premature newborns receiving mechanical ventilation support.

This study aims to answer the hypotheses

Descripción general del estudio

Estado

Activo, no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

The universe of the study will consist of premature newborns receiving ventilator support in the neonatal intensive care clinic of Selçuk University Medical Faculty Hospital. Three groups will be included in the study: the wrapping group (24), the breastfeeding group (24), and a control group (24). The study data will be collected using the Introductory Information Form, Preterm Infant Physiological Measurement Form, Premature Infant Comfort Scale, and the Neonatal Stress Scale. Before randomization, general information about the study will be given to the parents of newborns who meet the inclusion criteria, the mothers' consent will be obtained, and pre-test data will be collected. Premature newborns receiving ventilator support, whose pre-test data have been collected, will be assigned to the intervention and control groups using the simple randomization method. The intervention will be applied one hour after the 18:00 care, 10 minutes before the procedure, considering the calmest and most stable hours of the research unit, and will be evaluated at the fifth and twentieth minutes after the procedure.

Tipo de estudio

Intervencionista

Inscripción (Actual)

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.

Ubicaciones de estudio

  • Turquía (Türkiye)
    • Karatay
      • Konya, Karatay, Turquía (Türkiye), 42040
        • KTO Karatay University

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

No

Descripción

Inclusion Criteria:

  • Newborns with gestational weeks between 340/7-366/7,
  • In the first 28 days of life,
  • High-flow nasal cannula applied,
  • Birth weight 1500 gr and above,
  • Breastfeeding mothers,
  • No health problems that would prevent positioning,

Exclusion Criteria:

  • Those who have had a painful procedure within the last hour,
  • Those who have taken analgesic/sedative drugs within the last 6 hours,
  • Those who have undergone any surgical intervention,
  • Those with other diagnoses (hyperbilirubinemia, hypoglycemia, etc.),
  • Those with cerebral hypoxia/ischemia,
  • Those with intraventricular hemorrhage,
  • Newborns with congenital anomalies

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: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Breast Milk Smell Group
The premature newborn's own mother's milk will be dripped 10 drops onto a sterile gauze in a container one millimeter away from the newborn's nose, and the breast milk in the container will be placed in the incubator where the new baby is to be milked.
Otro: Breast Milk Smell
During the application, pre-test data and physiological measurement values, stress scale, and comfort scale levels are recorded three times, at the 5th and 20th minutes.
Experimental: Arson Group
A 90 cm² square muslin blanket will be used for wrapping. During the application, care will be taken to leave a certain space between the blanket and the newborn in order not to restrict the newborn's movements and to leave a suitable area where the newborn's feet can be comfortable when folding the bottom of the blanket.
Otro: Arson
In order to prevent the possibility of the wrapping increasing the body temperature, the incubator temperature, which is kept at a standard level, will be reduced by 1oC during the intervention. Pre-test data and physiological measurement values, stress scale and comfort scale levels will be recorded three times during the application, at the 5th and 20th minutes.
Experimental: Control Group
The control group of the study will not receive any intervention other than routine care.
Otro: Control
No intervention other than routine care will be applied to the control group of the study.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Premature Baby Comfort Scale
Periodo de tiempo: 9 Months
The scale was first developed by Ambuel et al. (1992) to assess the pain and stress levels of children aged 0-18 years hospitalized in a pediatric intensive care unit to determine the comfort levels of premature infants. It was later adapted by Caljouw et al. (2007) for premature infants aged 28-37 weeks. The scale is a 5-point Likert-type scale with seven subscales and 35 items. The subscales are defined as alertness, calmness/agitation, respiratory status or crying, physical movement, muscle tone, facial movements, and mean heart rate. The scale is a multidimensional measure that holistically assesses behavioral and physiological indicators of comfort in premature infants. As the total score on the scale increases, the infant's comfort level decreases; a score of 7 indicates the highest level of comfort, and a score of 35 indicates the lowest.
9 Months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Newborn Stress Scale
Periodo de tiempo: 9 Months
Developed by Ceylan and Bolışık (2017) to assess stress levels in premature infants, the scale consists of 24 items and 8 subscales: facial expression, body color, respiration, activity level, comfortability, muscle tone, extremities, and posture. Each item is scored on a 3-point Likert-type scale from 0 to 2. The total score ranges from 0 to 16, with higher scores indicating higher stress levels.
9 Months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

KTO Karatay University

Investigadores

  • Investigador principal: Hediye Karakoç, KTO Karatay Üniversitesi

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)

28 de junio de 2024

Finalización primaria (Actual)

30 de agosto de 2025

Finalización del estudio (Estimado)

30 de agosto de 2026

Fechas de registro del estudio

Enviado por primera vez

19 de agosto de 2025

Primero enviado que cumplió con los criterios de control de calidad

1 de julio de 2026

Publicado por primera vez (Actual)

2 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

1 de julio de 2026

Última verificación

1 de agosto de 2025

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • KARATAYU-SBF-ES-01

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Security

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. .

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