Virtual Reality Alternative to Pharmacological Sedation During Colonoscopy

Colonoscopy Clinical Trial

Official title:

A Pilot Study of Virtual Reality Technology as an Alternative to Pharmacological Sedation During Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04349150
• Other study ID #: 2018P001618
• Status: Completed
• Phase: N/A
• Start date: May 10, 2019
• Est. completion date: January 13, 2020

Study information

• Verified date: November 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study aims to assess whether virtual reality is an acceptable alternative to pharmacological sedation during colonoscopy. Past research has shown that in order to fully experience pain, one must pay attention to it. Virtual reality has been shown to help mitigate pain by providing distraction from the painful stimulus.

In this study, participants undergo screening or surveillance colonoscopy under virtual reality distraction.

Individuals who are scheduled for a routine screening or surveillance colonoscopy and have had at least one prior colonoscopy under conscious sedation are eligible to participate. Those who give written, informed consent are fitted with and oriented to a virtual reality head-mounted display. The subject is then prepped for the colonoscopy by a registered nurse per institution protocol. This includes placement of an intravenous line.

Written consent is obtained for colonoscopy with medication by the performing endoscopist. The patient is again fitted with the virtual reality head-mounted display and virtual experiences are initiated. The endoscopist performs the colonoscopy with the subject using virtual reality distraction instead of pharmacological sedation for as long as the subject likes. Standard sedatives and narcotics will be administered by a registered nurse upon participant request at any time during the procedure.

Following the procedure, participants and endoscopists complete a questionnaire about their subjective experience with virtual reality during colonoscopy. The research coordinator fills out a case report form for each subject with information about the procedure including length, colonoscopy findings, and complications as noted by the endoscopist.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: January 13, 2020
• Est. primary completion date: January 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult (18 years or older)

• Scheduled for screening or surveillance colonoscopy

• Has undergone at least 1 prior colonoscopy under conscious sedation

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Colonoscopy

Intervention

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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Participant-reported Pain and Discomfort Levels	participants will rate their pain and discomfort on a numeric rating scale of 1-10 (1 = no pain/discomfort, 10 = extreme pain/discomfort)	This data will be collected within 60 minutes of completion of the colonoscopy
Secondary	Participant Satisfaction	Participants will rate their satisfaction with their experience using virtual reality during colonoscopy on a numeric rating scale of 1-10 (1 = not satisfied, 10 = extremely satisfied).	This data will be collected within 60 minutes of completion of the colonoscopy
Secondary	Number of Participants Who Would Undergo Future Colonoscopies Using Virtual Reality and no Pharmacological Sedation	Participants will rate their willingness to undergo future colonoscopies using virtual reality and no pharmacological sedation as "Yes," "Maybe," or "No."	This data will be collected within 60 minutes of completion of the colonoscopy
Secondary	Endoscopist Satisfaction	Endoscopists will rate their satisfaction performing colonoscopy on participants using virtual reality instead of pharmacological sedation on a numeric rating scale of 1-10 (1 = not satisfied, 10 = extremely satisfied).	This data will be collected within 60 minutes of completion of the colonoscopy
Secondary	Number of Endoscopies Following Which Endoscopists Indicated Willingness to Incorporate Virtual Reality Into Regular Colonoscopy Practice	Endoscopists will indicate whether they would incorporate virtual reality into their regular colonoscopy practice by selecting one of the following: yes; no; yes, but I would use virtual reality as an adjunct therapy rather than a standalone therapy	This data will be collected within 60 minutes of completion of the colonoscopy