Virtual Reality Colonoscopy : a Study From Nancy

Colorectal Neoplasms Clinical Trial

Official title:

Virtual Reality Colonoscopy : a Study From Nancy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05203978
• Other study ID #: 2021PI080
• Status: Not yet recruiting
• Start date: March 2022
• Est. completion date: June 2022

Study information

• Verified date: February 2022
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: June 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Colorectal Polyp

Intervention

Procedure:
• colonoscopy
Colonoscopy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete colonoscopy defined by caecum intubation (binary criterion : yes or no)	found of the report	baseline
Secondary	Pain evaluated by Numeric Rating Scale during the procedure (0 no pain and 10 highest imaginable pain)	asked on the questionnaire	baseline
Secondary	Anxiety evaluated by the validated score State Trait Anxiety Inventory ranging from 20 (absence of anxiety) to 80 (highest anxiety)	asked on the questionnaire	baseline
Secondary	Comfort evaluated by Gloucester Comfort Scale between 1 comfortable and 5 severe discomfort	asked on the questionnaire	baseline
Secondary	Satisfaction evaluated on scale of willingness to return (0 no willing at all to 10 definitively willing)	asked on the questionnaire	baseline
Secondary	Polyp removal (binary criterion : yes or no)	found on the report	baseline