Feasibility and Ergonomic Impact of A Virtual Reality Headset in Endoscopic Procedures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorThe Cleveland Clinic
About this trial
The purpose of this study is to assess the feasibility of using a virtual reality headset (VRH) during endoscopy and its impact on the endoscopist ergonomics. We will use the Apple Vision Pro during approximately 140 endoscopic procedures during which ergonomics will be assessed.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Endoscopist: endoscopist at Cleveland Clinic Weston who consent to participate in the study and are performing either colonoscopy, EUS, or ERCP.
Patient: patient undergoing colonoscopy, EUS, or ERCP
Disqualifiers
Exclude the following procedures: Device-assisted colonoscopy (e.g.- double balloon, pathfinder, etc)
ERCP in native papilla
Cholangioscopy
Therapeutic EUS procedures (FNA/FNB, Stent Placement)
Trial design
Design model
Sequential
Treatments tested in this trial
Virtual reality headset
DeviceUse of the virtual reality headset during endoscopic procedures.
MYSELF checklist
Other interventionA preprocedural timeout to improve ergonomics.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: NonVRHActive comparator 1 intervention
Group B: VRHActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Risk Reduction of endoscopy related musculoskeletal injury by VRH as assessed by rapid entire body assessment (REBA) score.
The REBA score is an ergonomic assessment tool used to identify potential risks of musculoskeletal disorders in the workplace by evaluating posture and movements. The score ranges from 0-15 with 0 being the lowest risk and 15 being the highest risk. A two point decrease pre-intervention will be considered significant.
Time frame
From the start until the end of an endoscopic procedure.Secondary outcomes
1
Endoscopist experience with VRH assess via subjective survey scored on a 5-point Likert scale.
The survey includes six questions on ergonomics, technical feasibility, visual clarity, workflow, mental demands, and overall experience. Each question is scored 1-5 with the higher score being outcome.
Time frame
From the start until the end of an endoscopic procedure.2
Risk reduction of endoscopic related musculoskeletal injury in specific subgroups (colonoscopy, EUS, ERCP) by VRH as assessed by rapid entire body assessment (REBA) score.
The REBA score is an ergonomic assessment tool used to identify potential risks of musculoskeletal disorders in the workplace by evaluating posture and movements. The score ranges from 0-15 with 0 being the lowest risk and 15 being the highest risk. A two point decrease pre-intervention will be considered significant.
Time frame
From the start until the end of an endoscopic procedure.3
risk reduction of endoscopy related musculoskeletal injury due to pre-procedural checklist as assessed by rapid entire body assessment (REBA) score.
The REBA score is an ergonomic assessment tool used to identify potential risks of musculoskeletal disorders in the workplace by evaluating posture and movements. The score ranges from 0-15 with 0 being the lowest risk and 15 being the highest risk. A two point decrease pre-intervention will be considered significant.
Time frame
From the start until the end of an endoscopic procedure.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov