Use of Virtual Reality Technology as a Sedation Replacement During Colonoscopy

Patient Satisfaction Clinical Trial

Official title:

Use of Virtual Reality Technology as a Sedation Replacement During Colonoscopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05701566
• Other study ID #: 8177-21-IV-CTIL
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2023
• Source: Sheba Medical Center
• Contact: Ido Veisman, Dr.
• Phone: +97235307072
• Email: Ido.Veisman[@]sheba.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A pilot non-randomized controlled study examined whether the use of VR technology can serve as an appropriate substitute for sedation in a colonoscopy examination.

Description:

VR is an attention-distracting technology via visual and auditory signals by a computer-generated virtual engulfing environment. This technology has already been used in a variety of medical conditions and previous studies have demonstrated the benefit of using it as an additional tool for pain relief and as a substitute to sedation in invasive procedure. In this study we examined the use of VR as a substitute for sedation in colonoscopy. In this randomized control study, 60 patients were sequentially enrolled in a 1:1 ratio to either standard sedated colonoscopy or VR-unsedated procedure. The primary outcome was the overall satisfaction of patients who underwent unsedated colonoscopy with VR headset compared with patients who underwent standard sedation colonoscopy. Pain during the procedure, PDR, colonoscopy duration, post colonoscopy adverse events, post colonoscopy recovery and time-to-return to daily functions and turnaround time at the endoscopy unit were secondary outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients (=18) with any elective indication for colonoscopy.

Exclusion Criteria:

• known seizures' disorders, cognitive, visual or auditory impairment.
• patients who were unable or unwilling to sign an informed consent.
• Pregnant women.

Related Conditions & MeSH terms

• Patient Satisfaction

Intervention

Device:
• virtual reality headset
use of virtual reality headset during colonoscopy as a substitute to sedation.

Other:
• colonoscopy with standard sedation.
use of standard sedation during colonoscopy.

Locations

Country	Name	City	State
Israel	Gastroenterology department, Sheba Medical Center	Tel HaShomer

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall satisfaction of patients who underwent un-sedated colonoscopy with virtual reality (VR) headset compared with patients who underwent standard sedation colonoscopy.	Questionnaire (1 - not satisfied at all, 5 - very satisfied)	1 day
Secondary	Pain during the procedure	Questionnaire (1- severe pain, 5 - no pain at all)	1 day
Secondary	polyp detection rate (PDR)	number of polyps detected during colonoscopy	during colonoscopy procedure
Secondary	Colonoscopy duration	in minutes starting at insertion of the colonoscope to the anus until final withdrawal	during colonoscopy procedure
Secondary	Post colonoscopy adverse events	Questionnaire: Did you suffer from a general bad feeling after the test, including dizziness, nausea, abdominal pain (1 - no complaints at all, 5 - serious complaints)	1 day
Secondary	Time-to-return to daily activities (work, driving)	hours	1 day
Secondary	Turn-around time at the endoscopy Unit (overall duration of stay at the Endoscopy unit)	overall time at the unit	1 day