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The Effect of Replacement Frequency of Electrodes on Skin in Infant

21 de octubre de 2021 actualizado por: Zehra Kan Onturk, Acibadem University

The Effect of Replacement Frequency of Electrodes on Skin Moisture and Condition in Infants Hospitalized in the Pediatric Intensive Care Unit

In the Pediatric Intensive Care Unit (PICU), each child and infant is monitored to determine the status of the underlying disease by constantly monitoring the main variables, to help diagnosis and to guide treatment. During the monitoring application, electrodes of appropriate size for the patient's age and body surface are attached to the appropriate areas of the patient where skin integrity is intact, clean, and dry. It is recommended that these electrodes be replaced within 24 hours at most, but there is no evidence of the effect of electrode replacement frequency on skin moisture and integrity.

Based on this reason, this study was conducted experimentally in a randomized controlled manner to determine the effect of frequency of monitoring electrode replacement on skin moisture and condition of infants hospitalized in the PICU.

Descripción general del estudio

Descripción detallada

The study was conducted with 66 participants, with the number of participants being 33 in both two groups (Experimental and Control Group).The randomization of the sample was determined by entering the total number of cases in line with the Research Randomizer program.

The control group of the study involved infants whose monitoring electrodes were replaced at the 24th hour after being monitored and the experimental group involved infants whose monitoring electrodes were replaced at the 12th and 24th hour after being monitored.

Before all participants are monitored, skin cleansing was performed on the right second intercostal space (Right 2nd ICA), left second intercostal space (Left 2nd ICA) and the left lower side of the sternum at the left midclavicular level in the fifth intercostal space (Midclavicular 5th ICA). After that, skin moisture was measured where monitoring will be performed and skin condition evaluation of these areas. Then the participants were monitored.

After these applications, skin moisture and skin condition score evaluations were repeated in both groups.

Skin Condition Score The skin condition score, developed by the Association of Women's Health, Obstetric and Neonatal Nurses (AWHONN) and validated by Calisir et al. in 2016, was used to determine the skin condition. The scale consists of three items and each item includes an evaluation criterion. These are dryness, erythema, and skin integrity breakdown/peeling, respectively. Each item of the 3-point Likert scale gets 1 to 3 points. The lowest score that can be obtained from the scale is 3, the highest score is 9. A high total score indicates that the skin condition of the newborn is poor. Permission was obtained for the use of the skin condition score from the Association of Women's Health, Obstetric and Neonatal Nurses (AWHONN) and the authors who performed the Turkish validity and reliability.

Skin Moisture Digital Moisture Monitor For Skin was used to measure skin moisture. This moisture measuring device measures with "%". This device developed for precise measurement has been preferred because of its ability to show the amount of moisture by the contact without damaging the skin, being portable, working with a battery, having a wide measurement range (it can measure the amount of skin moisture from 0% to 99.9%), because of its fast, easy and reliable use, low cost, and its ability to measure in many anatomical regions.

Materials provided in accordance with the procurement procedure of the institution where the research was conducted and used in patient care during the data collection phase were preferred as consumable materials.

Researchers do not have any conflict of interest with companies regarding the preference of these materials. The consumables that are still used in the institution.

Tipo de estudio

Intervencionista

Inscripción (Actual)

33

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

      • Istanbul, Pavo
        • Acıbadem University Atakent Hospital

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

1 mes a 1 año (Niño)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Patients whose parents agreed to participate in the study and signed the informed consent form
  • No history of surgical procedures
  • Recently admitted to the unit and monitored for the first time
  • Infants aged ≥ 1 to 12 ≤ months

Exclusion Criteria:

  • Infants with a skin disease, with other diseases that can affect skin moisture and condition, with immune system 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
Otro: Control group (replacement every 24 hours)
The monitoring electrodes were not replaced for 24 hours, the electrodes were removed at the end of 24 hours (the protocol currently used in the institution) in control group.

Processing Steps:

  1. The monitoring electrodes were not replaced for 24 hours, the electrodes were removed at the end of 24 hours. During the 24-hour follow-up, patients whose electrodes were removed for any reason were excluded from the sample.
  2. Immediately after the drying, skin moisture measurement was made in the right 2nd intercostal space (ICA), left 2nd ICA, and midclavicular 5th ICA regions.
  3. The skin condition was evaluated from the areas monitored using the skin condition score by the researcher and another independent observer.
  4. The data were recorded.
Experimental: Experimental Group (replacement every 12 hours)
In the experimental group, the monitoring electrodes were replacement every 12 hours within 24 hours.

Processing Steps:

  1. Monitoring electrodes were removed at the end of the 12th hour. When removing the monitoring electrodes, the area was first wetted using a disinfectant and dried using a sponge after removing the electrodes.
  2. Immediately after the drying, skin moisture measurement was made in the right 2nd ICA, left 2nd ICA and midclavicular 5th ICA regions.
  3. The skin condition was evaluated from these areas monitored using the skin condition score by the researcher and another independent observer.
  4. Monitored again.
  5. Monitoring electrodes were removed at the end of the 24th hour. Cleaning and drying were done immediately after removal.
  6. Immediately after drying, skin moisture was measured from the monitored areas.
  7. The skin condition was evaluated from the areas monitored using the skin condition score by the researcher and another independent observer.
  8. The data were recorded.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in skin moisture
Periodo de tiempo: Data collected immediately before monitoring, after monitoring 12th hour (only for experimental group) and after 24 th hours. The change in these time intervals assessed.

Digital Moisture Monitor For Skin was used to measure skin moisture. This moisture measuring device measures with "%". This device developed for precise measurement has been preferred because of its ability to show the amount of moisture by the contact without damaging the skin, being portable, working with a battery, having a wide measurement range (it can measure the amount of skin moisture from 0% to 99.9%). As the moisture in the skin increases, the % increases.

Skin moisture measurement was made in the right 2nd ICA, left 2nd ICA, and midclavicular 5th ICA regions.

Data collected immediately before monitoring, after monitoring 12th hour (only for experimental group) and after 24 th hours. The change in these time intervals assessed.
Change in skin condition
Periodo de tiempo: Data collected immediately before monitoring, after monitoring 12th hour (only for experimental group) and after 24 th hours. The change in these time intervals assessed.
Skin condition were evaluated with the Skin Condition Assessment Scale. The scale consists of three items and each item includes an evaluation criterion. These are dryness, erythema, and skin integrity breakdown/peeling, respectively. Each item of the 3-point Likert scale gets 1 to 3 points. The lowest score that can be obtained from the scale is 3, the highest score is 9. A high total score indicates that the skin condition of the newborn is poor.
Data collected immediately before monitoring, after monitoring 12th hour (only for experimental group) and after 24 th hours. The change in these time intervals assessed.

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.

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)

31 de agosto de 2018

Finalización primaria (Actual)

17 de junio de 2019

Finalización del estudio (Actual)

17 de junio de 2019

Fechas de registro del estudio

Enviado por primera vez

16 de agosto de 2021

Primero enviado que cumplió con los criterios de control de calidad

16 de agosto de 2021

Publicado por primera vez (Actual)

23 de agosto de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

26 de octubre de 2021

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

21 de octubre de 2021

Última verificación

1 de octubre de 2021

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • ATADEK-2018/11

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. .

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