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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual reality | Experimental | Participants on this arm will have their colonoscopy initiated under virtual reality instead of standard sedatives and narcotics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality | Device | Intervention consists of providing virtual reality in place of standard sedatives and narcotics for a portion or the duration of the colonoscopy |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel C Chung, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
IPD will not be shared with other researchers
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | This data will be collected within 60 minutes of completion of the colonoscopy |
|
9 months
There were no adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel C. Chung, MD | Massachusetts General Hospital | 6177263544 | chung.daniel@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 1, 2020 | Sep 24, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 1, 2021 | Sep 24, 2021 | SAP_001.pdf |
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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:
| This data will be collected within 60 minutes of completion of the colonoscopy |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Medical history potentially impacting exam difficulty | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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. | Posted | Count of Participants | Participants | This data will be collected within 60 minutes of completion of the colonoscopy |
|
|
|
| Secondary | 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) | The 26 participants who did not request medication during colonoscopy. | Posted | Mean | Standard Deviation | units on a scale | This data will be collected within 60 minutes of completion of the colonoscopy |
|
|
|
| Secondary | 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). | The 26 participants who did not request medication during colonoscopy. | Posted | Mean | Standard Deviation | units on a scale | This data will be collected within 60 minutes of completion of the colonoscopy |
|
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| Secondary | 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." | The 26 participants who did not request medication during colonoscopy. | Posted | Number | participants | This data will be collected within 60 minutes of completion of the colonoscopy |
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| Secondary | 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). | The 26 participants who did not request medication during colonoscopy. | Posted | Mean | Standard Deviation | units on a scale | This data will be collected within 60 minutes of completion of the colonoscopy |
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| Secondary | 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:
| The four endoscopists participating in the study | Posted | Number | Endoscopies | This data will be collected within 60 minutes of completion of the colonoscopy |
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| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
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