Use of Virtual Reality Technology as a Sedation Replacement During Colonoscopy

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.

Study Overview

• Status: Recruiting
• Conditions: Patient Satisfaction
• Intervention / Treatment: Device: virtual reality headset; Other: colonoscopy with standard sedation.

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ido Veisman, Dr.; Phone Number: 7072 +97235307072; Email: Ido.Veisman@sheba.health.gov.il
• Study Contact Backup: Name: Revital Dvir, Mrs.; Phone Number: +97235307072; Email: revital.dvir@sheba.health.gov.il

Study Locations

• Israel
  • Tel HaShomer, Israel
    • Recruiting
    • Gastroenterology department, Sheba Medical Center
    • Contact: Ido Veisman, Dr.; Phone Number: +97235307072; Email: ido.veisman@sheba.health.gov.il
    • Contact: Revital Dvir; Phone Number: +97235307072; Email: revital.dvir@sheba.health.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: virtual reality group; unsedated colonoscopy using virtual reality headset.	Device: virtual reality headset; use of virtual reality headset during colonoscopy as a substitute to sedation.
Active Comparator: colonoscopy with standard sedation; standard sedated colonoscopy.	Other: colonoscopy with standard sedation.; use of standard sedation during colonoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain during the procedure	Questionnaire (1- severe pain, 5 - no pain at all)	1 day
polyp detection rate (PDR)	number of polyps detected during colonoscopy	during colonoscopy procedure
Colonoscopy duration	in minutes starting at insertion of the colonoscope to the anus until final withdrawal	during colonoscopy procedure
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
Time-to-return to daily activities (work, driving)	hours	1 day
Turn-around time at the endoscopy Unit (overall duration of stay at the Endoscopy unit)	overall time at the unit	1 day

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Investigators: Principal Investigator: Ido Veisman, Dr., Sheba Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): February 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: January 18, 2023
• First Submitted That Met QC Criteria: January 26, 2023
• First Posted (Actual): January 27, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 8177-21-IV-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No