- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04426227
Gaze Training on Task Performance Regional Anaesthesia
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 3
Kontakter och platser
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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
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Aktiv komparator: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Composite Error Score
Tidsram: 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.
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Objective error scoring of performance at needling task
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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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Global Rating Scale
Tidsram: 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.
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Task completion time
Tidsram: 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.
|
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Change in Fixation durations
Tidsram: 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.
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: David W Hewson, MBBS, University of Nottingham
Studieavstämningsdatum
Studera stora datum
Studiestart (Förväntat)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 434-1912
Plan för individuella deltagardata (IPD)
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