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Clinical Trials/NCT05203978
NCT05203978
Unknown
Not Applicable

Virtual Reality Colonoscopy : a Study From Nancy

Central Hospital, Nancy, France0 sites120 target enrollmentMarch 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Neoplasms
Sponsor
Central Hospital, Nancy, France
Enrollment
120
Primary Endpoint
Complete colonoscopy defined by caecum intubation (binary criterion : yes or no)
Last Updated
4 years ago

Overview

Brief Summary

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.

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
March 2022
End Date
June 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Central Hospital, Nancy, France
Responsible Party
Principal Investigator
Principal Investigator

Jean-Baptiste CHEVAUX

Hospital practitioner

Central Hospital, Nancy, France

Eligibility Criteria

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

Outcomes

Primary Outcomes

Complete colonoscopy defined by caecum intubation (binary criterion : yes or no)

Time Frame: baseline

found of the report

Secondary Outcomes

  • Satisfaction evaluated on scale of willingness to return (0 no willing at all to 10 definitively willing)(baseline)
  • Pain evaluated by Numeric Rating Scale during the procedure (0 no pain and 10 highest imaginable pain)(baseline)
  • Anxiety evaluated by the validated score State Trait Anxiety Inventory ranging from 20 (absence of anxiety) to 80 (highest anxiety)(baseline)
  • Polyp removal (binary criterion : yes or no)(baseline)
  • Comfort evaluated by Gloucester Comfort Scale between 1 comfortable and 5 severe discomfort(baseline)

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