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Effect of Work Load and Sleep Deprivation on Medical Staff's Driving Skills

23 de febrero de 2009 actualizado por: Hadassah Medical Organization
Long and unorthodox working hours (e.g. 24 hours or 23pm-07am shifts for doctors and nurses respectively) combined with sleep deprivation, may affect cognitive functions such as response time and concentration. These parameters may be tested using a driving simulator. Apart from the obvious consequences of driving skills impairment for the medical personal, it may serve as a quality assessment tool in evaluating the impact of workload and sleep deprivation on medical staff's function. This study aims to assess the effect of work load and sleep deprivation on medical staff's driving skills.

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

Descripción detallada

Medical staff in Israel has long and unorthodox working hours. During residency, doctors stay overnight for shifts after working the normal working hours for a total of 24h, without regular set breaks or certainty of even one hour of sleep. Nurses, has three 8 hours shifts, changing at 7am, 3pm and 11pm, meaning the night shift staff works between 11pm and 7am the following morning. These conditions, especially when in a routine when one shifts follow another, may contribute to an accumulated workload, associated with sleep deprivation. Such conditions may have considerable impact on cognitive functions such as response time and concentration, which are fundamental for medical personal's function.

The driving simulator is based on software (STIS Drive Simulation software, System Technology INC, Hawthorne CA) and a hardware consisting of a computer, screen, and two consoles, one includes a stirring wheel and press buttons, the second includes acceleration and break paddles. Each test drive has several stages, in which the following are measured - the ability to maintain constant speed, the ability to maintain driving lain, to follow another vehicle and to break abruptly. Additionally, during the test drive, several arrows appear on the screen, and the subject is requested to push curtain buttons as they appear according to their direction. This simulator has been used in several prior reports for driving skills evaluation.

In this study, medical staff will be asked to be tested with the driving simulator after night shift, allowing assessment of cognitive functions and response time.

  • Study design:

    • The study will include doctors and nurses from the internal medicine, surgical, orthopedic and pediatric wards which work night shifts.
    • The study will include both genders, ages 25-50.
    • The study is planned to include 100 volunteers.
  • Trial entry and enrollment

    • The medical staff at the participating departments will be approached orally (staff meetings etc') and signs will be posted at staff rooms.
    • Willing volunteers will be enrolled according to order of consent.

      **Visits 1 and 2

    • Visit 1 will include a training session in which the volunteer is introduced to the driving simulator's different functions and will perform a test ride to get experience. At this session, the subject will be asked to fill a form stating his age, residency and main occupation (e.g. extent of familiarity with laparoscopic/ endoscopic procedures).
    • Visit 2 will include a test ride performed during morning (07:00- 14:00pm) and after a regular night sleep and not after a night shift. Data collected during this session will be considered as baseline values. The following three test visits will be compared to these values.

      ** Visits 3-5

    • These visits will be performed after night shifts. Subjects will be tested at the morning (7-10am) following a night shift. Apart form a test drive each subject will be asked to state work and sleep hour during the previous day.

      ** Visit 6

    • Subjects which have completed 3 test drives will undergo a repeat baseline assessment (similar to visit 2) to which the following visits will be compared in order to minimize the learning curve component.

      ** Visits 7-9

    • Similar to visits 3-5.
  • Statistical considerations

    • Subjects will be grouped according to sleep hours prior to test drives, and driving simulator results will be compared.
    • Furthermore, additional analysis will be performed for individual subjects comparing achievements with sleep hours.
  • Informed consent

    • Each subject will be enrolled and enter the study only after giving an informed consent.
  • Adherence to study eligibility

    • The study will be conducted in accordance with good clinical practice (GCP) guidelines, and the study protocol.
  • Safeguarding of documents

    • The privacy of the subjects and all confidentiality issues will be handled in accordance with applicable law and guidelines of the institution and the Helsinki Committee, the Israeli ministry of health, or the other appropriate regulatory authorities.

Tipo de estudio

De observación

Inscripción (Anticipado)

100

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

Ubicaciones de estudio

    • Ein-Kerem
      • Jerusalem, Ein-Kerem, Israel, POB 12000
        • Hadassah Medical Organization, Jerusalem, Israel

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

25 años a 50 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Medical staff (doctors and nurses) working night shifts.

Descripción

Inclusion Criteria:

  • Given informed consent
  • Medical staff (doctor / nurse) working night shifts.
  • Having a driver's license.

Exclusion Criteria:

  • Pregnancy.
  • Any systemic / neurological condition which may affect results.

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

  • Modelos observacionales: Grupo
  • Perspectivas temporales: Futuro

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Study group
Medical staff personal, doctors and nurses, working night shifts.
Night shifts in our medical center are working 8 hours from 23:00 to 7:00 the following day for nurses, and working overnight (24h) for doctors.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Change in driving simulator test results after night shifts compared with control.
Periodo de tiempo: 2 months
2 months

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

1 de marzo de 2009

Finalización primaria (Anticipado)

1 de marzo de 2010

Fechas de registro del estudio

Enviado por primera vez

19 de febrero de 2009

Primero enviado que cumplió con los criterios de control de calidad

23 de febrero de 2009

Publicado por primera vez (Estimar)

24 de febrero de 2009

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

24 de febrero de 2009

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

23 de febrero de 2009

Última verificación

1 de febrero de 2009

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 481131-HMO-CTIL

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. .