Clinical trial NCT04349150: Virtual Reality Alternative to Pharmacological Sedation During Colonoscopy
Official title: A Pilot Study of Virtual Reality Technology as an Alternative to Pharmacological Sedation During Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy
Keywords: Virtual reality
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2020-04-16
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Participants Who Complete Colonoscopy Using Virtual Reality and no Pharmacological Rescue
timeFrame: This data will be collected within 60 minutes of completion of the colonoscopy
measure: Number of Participants With Cecal Intubation
timeFrame: This data will be collected within 60 minutes of completion of the colonoscopy
Secondary outcomes:
measure: Participant-reported Pain and Discomfort Levels
timeFrame: This data will be collected within 60 minutes of completion of the colonoscopy
measure: Participant Satisfaction
timeFrame: This data will be collected within 60 minutes of completion of the colonoscopy
measure: Number of Participants Who Would Undergo Future Colonoscopies Using Virtual Reality and no Pharmacological Sedation
timeFrame: This data will be collected within 60 minutes of completion of the colonoscopy
measure: Endoscopist Satisfaction
timeFrame: This data will be collected within 60 minutes of completion of the colonoscopy
measure: Number of Endoscopies Following Which Endoscopists Indicated Willingness to Incorporate Virtual Reality Into Regular Colonoscopy Practice
timeFrame: This data will be collected within 60 minutes of completion of the colonoscopy
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Daniel C Chung, MD
role: PRINCIPAL_INVESTIGATOR
References: