Virtual Reality Alternative to Pharmacological Sedation During Colonoscopy

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04349150
• Collaborator: (none)
• Enrollment: 31
• Location: 1
• Arm: 1
• Actual Duration (Months): 8.1
• Patients Per Site Per Month: 3.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colonoscopy	Device: Virtual reality	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Study of Virtual Reality Technology as an Alternative to Pharmacological Sedation During Colonoscopy
• Actual Study Start Date: May 10, 2019
• Actual Primary Completion Date: Jan 13, 2020
• Actual Study Completion Date: Jan 13, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Virtual reality Participants on this arm will have their colonoscopy initiated under virtual reality instead of standard sedatives and narcotics	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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

1. 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)

2. 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).

3. 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."

4. 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).

5. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital

Investigators

• Principal Investigator: Daniel C Chung, MD, Massachusetts General Hospital

Study Documents (Full-Text)

• Study Protocol - Sep 1, 2020
• Statistical Analysis Plan - Sep 1, 2021

More Information

Publications

None provided.

• Responsible Party: Daniel C Chung, Daniel C Chung, MD, Director of High-Risk GI Cancer Clinic, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT04349150
• Other Study ID Numbers: 2018P001618
• First Posted: Apr 16, 2020
• Last Update Posted: Dec 20, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Daniel C Chung, Daniel C Chung, MD, Director of High-Risk GI Cancer Clinic, Massachusetts General Hospital: Virtual reality

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Virtual Reality
Arm/Group Description	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
Period Title: Overall Study
STARTED	31
COMPLETED	27
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Virtual Reality
Arm/Group Description	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 Participants	27
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	63.9 (8.4)
Sex: Female, Male (Count of Participants)
Female	14 51.9%
Male	13 48.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	20 74.1%
Unknown or Not Reported	7 25.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	2 7.4%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	24 88.9%
More than one race	0 0%
Unknown or Not Reported	1 3.7%
Medical history potentially impacting exam difficulty (Count of Participants)
Abdominal/pelvic surgery	11 40.7%
Tortuous colon	1 3.7%
None	15 55.6%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Who Complete Colonoscopy Using Virtual Reality and no Pharmacological Rescue
Description	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.
Time Frame	This data will be collected within 60 minutes of completion of the colonoscopy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Virtual Reality
Arm/Group Description	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
Measure Participants	27
Count of Participants [Participants]	26 96.3%

2. Primary Outcome

Title	Number of Participants With Cecal Intubation
Description	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.
Time Frame	This data will be collected within 60 minutes of completion of the colonoscopy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Virtual Reality
Arm/Group Description	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
Measure Participants	27
Count of Participants [Participants]	27 100%

3. Secondary Outcome

Title	Participant-reported Pain and Discomfort Levels
Description	participants will rate their pain and discomfort on a numeric rating scale of 1-10 (1 = no pain/discomfort, 10 = extreme pain/discomfort)
Time Frame	This data will be collected within 60 minutes of completion of the colonoscopy

Outcome Measure Data

Analysis Population Description

The 26 participants who did not request medication during colonoscopy.

Arm/Group Title	Virtual Reality
Arm/Group Description	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
Measure Participants	26
Pain	3.6 (1.6)
Discomfort	4.0 (1.4)

4. Secondary Outcome

Title	Participant Satisfaction
Description	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).
Time Frame	This data will be collected within 60 minutes of completion of the colonoscopy

Outcome Measure Data

Analysis Population Description

The 26 participants who did not request medication during colonoscopy.

Arm/Group Title	Virtual Reality
Arm/Group Description	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
Measure Participants	26
Mean (Standard Deviation) [units on a scale]	7.3 (2.5)

5. Secondary Outcome

Title	Number of Participants Who Would Undergo Future Colonoscopies Using Virtual Reality and no Pharmacological Sedation
Description	Participants will rate their willingness to undergo future colonoscopies using virtual reality and no pharmacological sedation as "Yes," "Maybe," or "No."
Time Frame	This data will be collected within 60 minutes of completion of the colonoscopy

Outcome Measure Data

Analysis Population Description

The 26 participants who did not request medication during colonoscopy.

Arm/Group Title	Virtual Reality
Arm/Group Description	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
Measure Participants	26
Yes	18 66.7%
Maybe	7 25.9%
No	1 3.7%

6. Secondary Outcome

Title	Endoscopist Satisfaction
Description	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).
Time Frame	This data will be collected within 60 minutes of completion of the colonoscopy

Outcome Measure Data

Analysis Population Description

The 26 participants who did not request medication during colonoscopy.

Arm/Group Title	Virtual Reality
Arm/Group Description	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
Measure Participants	26
Mean (Standard Deviation) [units on a scale]	8.6 (1.8)

7. Secondary Outcome

Title	Number of Endoscopies Following Which Endoscopists Indicated Willingness to Incorporate Virtual Reality Into Regular Colonoscopy Practice
Description	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
Time Frame	This data will be collected within 60 minutes of completion of the colonoscopy

Outcome Measure Data

Analysis Population Description

The four endoscopists participating in the study

Arm/Group Title	Virtual Reality
Arm/Group Description	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
Measure Participants	4
Yes	19
No	0
Yes, but I would use virtual reality as an adjunct therapy rather than a standalone therapy	6

Adverse Events

Time Frame	9 months
Adverse Event Reporting Description	There were no adverse events.
Arm/Group Title	Virtual Reality
Arm/Group Description	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
All Cause Mortality
	Virtual Reality
	Affected / at Risk (%)	# Events
Total	0/27 (0%)
Serious Adverse Events
	Virtual Reality
	Affected / at Risk (%)	# Events
Total	0/27 (0%)
Other (Not Including Serious) Adverse Events
	Virtual Reality
	Affected / at Risk (%)	# Events
Total	0/27 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.