Trial Outcomes & Findings for Virtual Reality Alternative to Pharmacological Sedation During Colonoscopy (NCT NCT04349150)
NCT ID: NCT04349150
Last Updated: 2021-12-20
Results Overview
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.
COMPLETED
NA
31 participants
This data will be collected within 60 minutes of completion of the colonoscopy
2021-12-20
Participant Flow
All individuals scheduled for screening/surveillance colonoscopy who had previously undergone more than one colonoscopy under conscious sedation and were patients of any of four endoscopists at our institution were invited to participate.
Participant milestones
| Measure |
Virtual Reality
Participants on this arm will have their colonoscopy initiated under virtual reality instead of standard sedatives and narcotics
Virtual reality: Intervention consists of providing virtual reality in place of standard sedatives and narcotics for a portion or the duration of the colonoscopy
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Virtual Reality Alternative to Pharmacological Sedation During Colonoscopy
Baseline characteristics by cohort
| Measure |
Virtual Reality
n=27 Participants
Participants on this arm will have their colonoscopy initiated under virtual reality instead of standard sedatives and narcotics
Virtual reality: Intervention consists of providing virtual reality in place of standard sedatives and narcotics for a portion or the duration of the colonoscopy
|
|---|---|
|
Age, Continuous
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63.9 Years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Medical history potentially impacting exam difficulty
Abdominal/pelvic surgery
|
11 Participants
n=5 Participants
|
|
Medical history potentially impacting exam difficulty
Tortuous colon
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1 Participants
n=5 Participants
|
|
Medical history potentially impacting exam difficulty
None
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: This data will be collected within 60 minutes of completion of the colonoscopyMeasured 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.
Outcome measures
| Measure |
Virtual Reality
n=27 Participants
Participants on this arm will have their colonoscopy initiated under virtual reality instead of standard sedatives and narcotics
Virtual reality: Intervention consists of providing virtual reality in place of standard sedatives and narcotics for a portion or the duration of the colonoscopy
|
|---|---|
|
Percentage of Participants Who Complete Colonoscopy Using Virtual Reality and no Pharmacological Rescue
|
26 Participants
|
PRIMARY outcome
Timeframe: This data will be collected within 60 minutes of completion of the colonoscopyNumber 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.
Outcome measures
| Measure |
Virtual Reality
n=27 Participants
Participants on this arm will have their colonoscopy initiated under virtual reality instead of standard sedatives and narcotics
Virtual reality: Intervention consists of providing virtual reality in place of standard sedatives and narcotics for a portion or the duration of the colonoscopy
|
|---|---|
|
Number of Participants With Cecal Intubation
|
27 Participants
|
SECONDARY outcome
Timeframe: This data will be collected within 60 minutes of completion of the colonoscopyPopulation: The 26 participants who did not request medication during colonoscopy.
participants will rate their pain and discomfort on a numeric rating scale of 1-10 (1 = no pain/discomfort, 10 = extreme pain/discomfort)
Outcome measures
| Measure |
Virtual Reality
n=26 Participants
Participants on this arm will have their colonoscopy initiated under virtual reality instead of standard sedatives and narcotics
Virtual reality: Intervention consists of providing virtual reality in place of standard sedatives and narcotics for a portion or the duration of the colonoscopy
|
|---|---|
|
Participant-reported Pain and Discomfort Levels
Pain
|
3.6 units on a scale
Standard Deviation 1.6
|
|
Participant-reported Pain and Discomfort Levels
Discomfort
|
4.0 units on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: This data will be collected within 60 minutes of completion of the colonoscopyPopulation: The 26 participants who did not request medication during 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).
Outcome measures
| Measure |
Virtual Reality
n=26 Participants
Participants on this arm will have their colonoscopy initiated under virtual reality instead of standard sedatives and narcotics
Virtual reality: Intervention consists of providing virtual reality in place of standard sedatives and narcotics for a portion or the duration of the colonoscopy
|
|---|---|
|
Participant Satisfaction
|
7.3 units on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: This data will be collected within 60 minutes of completion of the colonoscopyPopulation: The 26 participants who did not request medication during colonoscopy.
Participants will rate their willingness to undergo future colonoscopies using virtual reality and no pharmacological sedation as "Yes," "Maybe," or "No."
Outcome measures
| Measure |
Virtual Reality
n=26 Participants
Participants on this arm will have their colonoscopy initiated under virtual reality instead of standard sedatives and narcotics
Virtual reality: Intervention consists of providing virtual reality in place of standard sedatives and narcotics for a portion or the duration of the colonoscopy
|
|---|---|
|
Number of Participants Who Would Undergo Future Colonoscopies Using Virtual Reality and no Pharmacological Sedation
Yes
|
18 participants
|
|
Number of Participants Who Would Undergo Future Colonoscopies Using Virtual Reality and no Pharmacological Sedation
Maybe
|
7 participants
|
|
Number of Participants Who Would Undergo Future Colonoscopies Using Virtual Reality and no Pharmacological Sedation
No
|
1 participants
|
SECONDARY outcome
Timeframe: This data will be collected within 60 minutes of completion of the colonoscopyPopulation: The 26 participants who did not request medication during 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).
Outcome measures
| Measure |
Virtual Reality
n=26 Participants
Participants on this arm will have their colonoscopy initiated under virtual reality instead of standard sedatives and narcotics
Virtual reality: Intervention consists of providing virtual reality in place of standard sedatives and narcotics for a portion or the duration of the colonoscopy
|
|---|---|
|
Endoscopist Satisfaction
|
8.6 units on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: This data will be collected within 60 minutes of completion of the colonoscopyPopulation: The four endoscopists participating in the study
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
Outcome measures
| Measure |
Virtual Reality
n=4 Participants
Participants on this arm will have their colonoscopy initiated under virtual reality instead of standard sedatives and narcotics
Virtual reality: Intervention consists of providing virtual reality in place of standard sedatives and narcotics for a portion or the duration of the colonoscopy
|
|---|---|
|
Number of Endoscopies Following Which Endoscopists Indicated Willingness to Incorporate Virtual Reality Into Regular Colonoscopy Practice
No
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0 Endoscopies
|
|
Number of Endoscopies Following Which Endoscopists Indicated Willingness to Incorporate Virtual Reality Into Regular Colonoscopy Practice
Yes, but I would use virtual reality as an adjunct therapy rather than a standalone therapy
|
6 Endoscopies
|
|
Number of Endoscopies Following Which Endoscopists Indicated Willingness to Incorporate Virtual Reality Into Regular Colonoscopy Practice
Yes
|
19 Endoscopies
|
Adverse Events
Virtual Reality
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place