Virtual Reality Alternative to Pharmacological Sedation During Colonoscopy

NCT04349150 | Completed Results

• 1 other identifier: 2018P001618
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Colonoscopy patients will be fitted with a virtual reality head-mounted display, and virtual experiences will be initiated prior to colonoscope insertion. Colonoscopy will be initiated without standard sedatives and narcotics. The colonoscopy will proceed with the subject using virtual reality distraction instead of pharmacological sedation for as long as s/he would like. Standard sedatives and narcotics will be administered upon participant request at any time during the procedure. Questionnaires will be administered to the subject and the endoscopist after each procedure to assess the acceptability of use of virtual reality in the colonoscopy setting.

Conditions

Colonoscopy

Keywords

Virtual reality

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Who Complete Colonoscopy Using Virtual Reality and no Pharmacological Rescue

  Measured as (x/n) \* 100, where x = number of participants who completed colonoscopy using virtual reality and no pharmacological rescue, and n = total number of participants who initiated colonoscopy using virtual reality.

  This data will be collected within 60 minutes of completion of the colonoscopy

• Number of Participants With Cecal Intubation

  Number of Participants with Cecal Intubation using virtual reality and no pharmacological sedation. Measured as x/n, where x = number of participants in whom cecal intubation is achieved when participant is using virtual reality and no pharmacological sedation, and n = total number of participants who initiated colonoscopy using virtual reality.

  This data will be collected within 60 minutes of completion of the colonoscopy

Secondary Outcomes (5)

• Participant-reported Pain and Discomfort Levels

  This data will be collected within 60 minutes of completion of the colonoscopy

• Participant Satisfaction

  This data will be collected within 60 minutes of completion of the colonoscopy

• Number of Participants Who Would Undergo Future Colonoscopies Using Virtual Reality and no Pharmacological Sedation

  This data will be collected within 60 minutes of completion of the colonoscopy

• Endoscopist Satisfaction

  This data will be collected within 60 minutes of completion of the colonoscopy

• Number of Endoscopies Following Which Endoscopists Indicated Willingness to Incorporate Virtual Reality Into Regular Colonoscopy Practice

  This data will be collected within 60 minutes of completion of the colonoscopy

Study Arms (1)

Virtual reality

EXPERIMENTAL

Participants on this arm will have their colonoscopy initiated under virtual reality instead of standard sedatives and narcotics

Device: Virtual reality

Interventions

Virtual reality DEVICE

Intervention consists of providing virtual reality in place of standard sedatives and narcotics for a portion or the duration of the colonoscopy

Virtual reality

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (18 years or older)
• Scheduled for screening or surveillance colonoscopy
• Has undergone at least 1 prior colonoscopy under conscious sedation

You may not qualify if:

• Children (\<18 years)
• Scheduled to undergo colonoscopy under general anesthesia
• Scheduled to undergo colonoscopy with no sedation
• First-time colonoscopy patients
• Scheduled for colonoscopy to assess symptoms or pre-existing disease

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Results Point of Contact

• Title: Daniel C. Chung, MD
• Organization: Massachusetts General Hospital

chung.daniel@mgh.harvard.edu

6177263544

Study Officials

• Daniel C Chung, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Daniel C Chung, MD, Director of High-Risk GI Cancer Clinic

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: April 16, 2020
• Study Start: May 10, 2019
• Primary Completion: January 13, 2020
• Study Completion: January 13, 2020
• Last Updated: December 20, 2021
• Results First Posted: December 20, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)