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Gaze Training on Task Performance Regional Anaesthesia

9 de junio de 2020 actualizado por: David Hewson, University of Nottingham

The Effect of Gaze Training on Task Performance and Skill Acquisition in Ultrasound-guided Regional Anaesthesia: a Partially Blinded Randomised Controlled Trial.

Regional anaesthesia is the performance of spinal, epidural or peripheral nerve blocks to allow patients to undergo surgery awake and to provide post-operative pain relief. Anaesthetists inject local anaesthetic using specialist needles close to nerves to prevent transmission of pain. Hand-held ultrasound is often used by anaesthetists to direct these needles to the correct position i.e. close to, but not in the nerve itself. If the needle is not adequately seen using the hand-held ultrasound it may pierce the nerve causing permanent nerve damage and significant patient harm.

Within the time and resource constraints of postgraduate medical training, it would be advantageous to optimise expertise acquisition of practical skills with a cheap, self-directed educational intervention. Therefore, the aim of this study is to determine whether gaze training is associated with improved performance of an ultrasound-guided needle task. The investigators hypothesise that improved gaze control will translate to better technical performance of an ultrasound-guided regional anaesthesia task.

Descripción general del estudio

Estado

Desconocido

Condiciones

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

43

Fase

  • Fase 3

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.

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
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Undergraduate Science, Technology, Engineering or Maths (STEM) students who are capable of giving informed consent

Exclusion Criteria:

  • Previous experience of gaze training or eye tracking software
  • Previous experience of regional anaesthesia needling tasks

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: Otro
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Group Gaze
The gaze-trained group will be shown a video, derived from the eye tracker, of an expert's visual control whilst performing the ultrasound task. Participants will be made aware of the target-focused gaze strategy (lengthy and stable fixations on the needling target), and the manner in which the gaze shifted from target to tools (hands, needle and transducer) in a fast, smooth fashion. They will then be advised to try to mimic the gaze strategy of the expert while undertaking the needling task as their first training task. After completion of this training task, participants will be shown their own video data, as captured by the eye tracker. Participants will be asked to comment on differences between their own video and the expert video they had previously seen. This feedback process will be replicated a further four training task attempts. Participants in this group will therefore undergo a total of five training attempts of the needling task.
A training module in gaze training for peripheral nerve blockade
Comparador activo: Group Discovery
The discovery learning group will be given no video feedback and will be instructed to perform five training attempts at the needling task without further training or feedback.
A phase of discovery learning guided by novice operators themselves

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Composite Error Score
Periodo de tiempo: Undertaken during ultrasound assessment 1 (before training intervention) and during ultrasound assessment 2 (which will occur 10 minutes after the training intervention was undertaken). Each assessment will be 15 minutes in duration.
Objective error scoring of performance at needling task
Undertaken during ultrasound assessment 1 (before training intervention) and during ultrasound assessment 2 (which will occur 10 minutes after the training intervention was undertaken). Each assessment will be 15 minutes in duration.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Global Rating Scale
Periodo de tiempo: Undertaken during ultrasound assessment 1 (before training intervention) and during ultrasound assessment 2 (which will occur 10 minutes after the training intervention). Each assessment will be 15 minutes in duration.
Objective performance scoring of needling task, scored from 0-35, higher scores indicating better task performance.
Undertaken during ultrasound assessment 1 (before training intervention) and during ultrasound assessment 2 (which will occur 10 minutes after the training intervention). Each assessment will be 15 minutes in duration.

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Task completion time
Periodo de tiempo: Undertaken during ultrasound assessment 1 (before training intervention) and during ultrasound assessment 2 (which will occur 10 minutes after the training intervention was undertaken). Each assessment will be 15 minutes in duration.
Time taken to finish needling task
Undertaken during ultrasound assessment 1 (before training intervention) and during ultrasound assessment 2 (which will occur 10 minutes after the training intervention was undertaken). Each assessment will be 15 minutes in duration.
Change in Fixation durations
Periodo de tiempo: Undertaken during ultrasound assessment 1 (before training intervention) and during ultrasound assessment 2 (which will occur 10 minutes after the training intervention was undertaken). Each assessment will be 15 minutes in duration.
The total duration in seconds during the task that the participant spends engaging fixation visual behaviour in pre-defined areas of interest during the needling task
Undertaken during ultrasound assessment 1 (before training intervention) and during ultrasound assessment 2 (which will occur 10 minutes after the training intervention was undertaken). Each assessment will be 15 minutes in duration.

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: David W Hewson, MBBS, University of Nottingham

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 (Anticipado)

1 de agosto de 2020

Finalización primaria (Anticipado)

1 de diciembre de 2020

Finalización del estudio (Anticipado)

1 de diciembre de 2020

Fechas de registro del estudio

Enviado por primera vez

2 de junio de 2020

Primero enviado que cumplió con los criterios de control de calidad

9 de junio de 2020

Publicado por primera vez (Actual)

11 de junio de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de junio de 2020

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

9 de junio de 2020

Última verificación

1 de junio de 2020

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 434-1912

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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