Virtual Reality Alternative to Pharmacological Sedation During Colonoscopy

Study Overview
=================
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.

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

Conditions
-----------------
Colonoscopy

Intervention / Treatment
-----------------
* Device: Virtual reality


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality<br>Participants on this arm will have their colonoscopy initiated under virtual reality instead of standard sedatives and narcotics | Device: Virtual reality<br>* Intervention consists of providing virtual reality in place of standard sedatives and narcotics for a portion or the duration of the colonoscopy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Virtual reality