Clinical trial NCT02092493: The Effect of ScopeGuide on the Mental Workload of Endoscopist
Official title: The Effect of Magnetic Endoscopic Imaging (ScopeGuide) on the Mental Workload of Endoscopists During Colonoscopy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Any Symptoms Requiring Colonoscopy
Keywords: ScopeGuide
Colonoscopy
Mental workload
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
First posted: 2014-03-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: ScopeGuide (Magnetic endoscopic imaging) is a device used during some colonoscopies which provides real-time 3D image of the shape and configuration of the colonoscope as it travels through the colon. Whilst it is being used in clinical practice in most units in the UK, it is not a device which is routinely used on all lists, and most departments do not own enough ScopeGuides to have on all lists. Studies have shown it can potentially aid colonoscopy by improving completion rates and times as well as patient comfort in selected endoscopists (persons who perform the colonoscopy). However data on its benefit have been conflicting.

Subjective mental workload (the individuals mental resources required as a result of the multiple demands placed on him/her from a task)in healthcare employees is known to be important for the performance and safety of healthcare delivery. Increased workload during task performance may increase fatigue, facilitate errors and lead to overall inferior performance.

In colonoscopy high mental workload could potentially be responsible for longer procedural time, lack of trainee learning, inadvertent missing of lesions in the bowel as well as poor technique leading to patient discomfort. The effect of the endoscopist mental workload on their performance and potential facilitators to reduce mental workload is an area that has been neglected in this field.

This study aims to look at the mental workload of endoscopist during colonoscopy and the effect ScopeGuide may have on this workload.

Hypothesis: The use of ScopeGuide during colonoscopy will reduce the mental workload of the endoscopist performing the procedure


Eligibility criteria: Inclusion Criteria:

* All endoscopist performing colonoscopy at University hospital Southampton endoscopy unit
* All adult patients attending diagnostic colonoscopy

Exclusion Criteria:

* Endoscopist preference
* Patients unable to give informed consent
* Patient preference
* Patients with new diagnosis of colonic cancer

Primary outcomes:
measure: mental workload scores for endoscopist performing colonoscopy (represented by the NASA-task load index scores on a visual analogue scale (VAS) ranging from 0-600)
timeFrame: within 1 hour of beginning procedure
measure: Caecal intubation times, recorded in minutes and seconds
timeFrame: within 1 hour of beginning procedure
Secondary outcomes:
measure: Withdrawal time measured in minutes and second
timeFrame: within 1 hour of beginning procedure
measure: Overall procedure times in minutes and seconds
timeFrame: within 1 hour of beginning procedure
measure: -'Timing' of procedures (day & am/pm & order on list)
timeFrame: upto 1 hour before beginning procedure
measure: Polyp detection
timeFrame: within 1 hour of beginning procedure
measure: Patient comfort scores on a visual analogue scale
timeFrame: within 1 hour of completing procedure
measure: Sedation dose measured in milligrams and micrograms
timeFrame: within 1 hour of completing procedure
measure: Patient pre-endoscopy anxiety levels measured on visual analogue scale
timeFrame: upto 1 hour before beginning procedure
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: University Hospital Southampton
state: Hamshire
Study officials:
affiliation: University Hospital Southampton NHS Foundation Trust
name: Imdadur Rahman, MBChB MRCP
role: PRINCIPAL_INVESTIGATOR
References: