Virtual Reality Alternative to Pharmacological Sedation During Colonoscopy

Not Applicable

Completed

Conditions: Colonoscopy

Interventions: Device: Virtual reality

Registration Number: NCT04349150

Lead Sponsor: Massachusetts General Hospital

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.

Detailed 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 & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 31

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Complete Colonoscopy Using Virtual Reality and no Pharmacological Rescue	This data will be collected within 60 minutes of completion of the colonoscopy	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.
Number of Participants With Cecal Intubation	This data will be collected within 60 minutes of completion of the colonoscopy	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.

Secondary Outcome Measures

Name	Time	Method
Participant Satisfaction	This data will be collected within 60 minutes of completion of the colonoscopy	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).
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	Participants will rate their willingness to undergo future colonoscopies using virtual reality and no pharmacological sedation as "Yes," "Maybe," or "No."
Endoscopist Satisfaction	This data will be collected within 60 minutes of completion of the colonoscopy	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).
Participant-reported Pain and Discomfort Levels	This data will be collected within 60 minutes of completion of the colonoscopy	participants will rate their pain and discomfort on a numeric rating scale of 1-10 (1 = no pain/discomfort, 10 = extreme pain/discomfort)
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	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