Virtual Reality Colonoscopy : a Study From Nancy
Colonoscopy is an exam which can be responsible for pain and discomfort for the patient.
Therefore colonoscopy is performed most of the time under general anaesthesia. Moreover, drug-induced sedation comes with adverse effects especially among fragile patients.
Besides, monitoring patients during and after sedation is both logistically demanding and costly.
Virtual reality offers immersive and three dimensional experiences that distract the attention and might improve patients comfort.
The aim of the study is to investigate the use of virtual reality during colonoscopy versus general anaesthesia.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patient needed planned colonoscopy
- able to fill in questionnaires in French
Exclusion Criteria:
- visual or auditor impairments
- dementia patient
- limited French language skills
- diagnosis of balance disorders or epilepsy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Virtual reality colonoscopy
using virtual reality with glasses and sound no anaesthesia
|
Colonoscopy
|
|
General anaesthesia colonoscopy
gold standard
|
Colonoscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Complete colonoscopy defined by caecum intubation (binary criterion : yes or no)
Time Frame: baseline
|
found of the report
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain evaluated by Numeric Rating Scale during the procedure (0 no pain and 10 highest imaginable pain)
Time Frame: baseline
|
asked on the questionnaire
|
baseline
|
|
Anxiety evaluated by the validated score State Trait Anxiety Inventory ranging from 20 (absence of anxiety) to 80 (highest anxiety)
Time Frame: baseline
|
asked on the questionnaire
|
baseline
|
|
Comfort evaluated by Gloucester Comfort Scale between 1 comfortable and 5 severe discomfort
Time Frame: baseline
|
asked on the questionnaire
|
baseline
|
|
Satisfaction evaluated on scale of willingness to return (0 no willing at all to 10 definitively willing)
Time Frame: baseline
|
asked on the questionnaire
|
baseline
|
|
Polyp removal (binary criterion : yes or no)
Time Frame: baseline
|
found on the report
|
baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021PI080
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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