Virtual Reality Colonoscopy : a Study From Nancy

NCT05203978 | Unknown

• 1 other identifier: 2021PI080
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colorectal Neoplasms; Colorectal Polyp

Outcome Measures

Primary Outcomes (1)

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

  found of the report

  baseline

Secondary Outcomes (5)

• 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

• Comfort evaluated by Gloucester Comfort Scale between 1 comfortable and 5 severe discomfort

  baseline

• Satisfaction evaluated on scale of willingness to return (0 no willing at all to 10 definitively willing)

  baseline

• Polyp removal (binary criterion : yes or no)

  baseline

Study Arms (2)

Virtual reality colonoscopy

using virtual reality with glasses and sound no anaesthesia

Procedure: colonoscopy

General anaesthesia colonoscopy

gold standard

Procedure: colonoscopy

Interventions

colonoscopy PROCEDURE

Colonoscopy

General anaesthesia colonoscopy; Virtual reality colonoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• patient needed planned colonoscopy
• able to fill in questionnaires in French

You may not qualify if:

• visual or auditor impairments
• dementia patient
• limited French language skills
• diagnosis of balance disorders or epilepsy

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hospital practitioner

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: January 24, 2022
• Study Start: March 1, 2022
• Primary Completion: March 1, 2022
• Study Completion: June 1, 2022
• Last Updated: March 8, 2022

Record last verified: 2022-02