Virtual Reality Colonoscopy : a Study From Nancy

Overview

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 Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 2022

Detailed Description

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

Interventions

  • Procedure: colonoscopy
    • Colonoscopy

Arms, Groups and Cohorts

  • Virtual reality colonoscopy
    • using virtual reality with glasses and sound no anaesthesia
  • General anaesthesia colonoscopy
    • gold standard

Clinical Trial Outcome Measures

Primary Measures

  • Complete colonoscopy defined by caecum intubation (binary criterion : yes or no)
    • Time Frame: baseline
    • found of the report

Secondary Measures

  • Pain evaluated by Numeric Rating Scale during the procedure (0 no pain and 10 highest imaginable pain)
    • Time Frame: baseline
    • asked on the questionnaire
  • 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
  • Comfort evaluated by Gloucester Comfort Scale between 1 comfortable and 5 severe discomfort
    • Time Frame: baseline
    • asked on the questionnaire
  • Satisfaction evaluated on scale of willingness to return (0 no willing at all to 10 definitively willing)
    • Time Frame: baseline
    • asked on the questionnaire
  • Polyp removal (binary criterion : yes or no)
    • Time Frame: baseline
    • found on the report

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Central Hospital, Nancy, France
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jean-Baptiste CHEVAUX, Hospital practitioner – Central Hospital, Nancy, France

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