Virtual Reality Colonoscopy : a Study From Nancy

• Conditions: Colorectal Neoplasms; Colorectal Polyp
• Interventions: Procedure: colonoscopy

• Registration Number: NCT05203978
• Lead Sponsor: Central Hospital, Nancy, France

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.

Study Timeline

• Study First Submitted: 2021-11-29
• Study First Submitted QC: 2022-01-10
• Study First Posted: 2022-01-24
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-20
• Study Start: 2022-03
• Primary Completion: 2022-03
• Last Update Posted: 2022-03-08
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Virtual reality colonoscopy	colonoscopy	using virtual reality with glasses and sound no anaesthesia
General anaesthesia colonoscopy	colonoscopy	gold standard

Primary Outcome Measures

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

Secondary Outcome Measures

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