Virtual Reality Colonoscopy : a Study From Nancy

February 20, 2022 updated by: Jean-Baptiste CHEVAUX, Central Hospital, Nancy, France

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

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The study is based on a home made questionnaires completed by the operator and the patient before and after the colonoscopy.

Study Type

Observational

Enrollment (Anticipated)

120

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patient needed planned colonoscopy and able to fill in questionnaires in French

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Procedure: colonoscopy
Colonoscopy
General anaesthesia colonoscopy
gold standard
Procedure: colonoscopy
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

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2022

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

November 29, 2021

First Submitted That Met QC Criteria

January 10, 2022

First Posted (Actual)

January 24, 2022

Study Record Updates

Last Update Posted (Actual)

March 8, 2022

Last Update Submitted That Met QC Criteria

February 20, 2022

Last Verified

February 1, 2022

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

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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