ColonoscopyNCT04349150
Virtual Reality Alternative to Pharmacological Sedation During Colonoscopy
A study testing Virtual reality in people with Colonoscopy, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Virtual reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2019to 13 Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult (18 years or older)
- Scheduled for screening or surveillance colonoscopy
- Has undergone at least 1 prior colonoscopy under conscious sedation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Pilot Study of Virtual Reality Technology as an Alternative to Pharmacological Sedation During Colonoscopy
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.
Read the 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.
- Conditions
- Colonoscopy
- Being tested
- Virtual reality
- Keywords
- Virtual reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityDevice
Intervention consists of providing virtual reality in place of standard sedatives and narcotics for a portion or the duration of the colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality | Experimental | Participants on this arm will have their colonoscopy initiated under virtual reality instead of standard sedatives and narcotics Receives: Device: Virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: This data will be collected within 60 minutes of completion of the colonoscopy
Secondary outcomes (5)
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)
Measured: 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).
Measured: 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."
Measured: 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).
Measured: 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
Measured: This data will be collected within 60 minutes of completion of the colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start10 May 2019
- Primary completion13 Jan 2020
- Study completion13 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel C Chung, Massachusetts General Hospital
- Investigators
- Daniel C Chung, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349150
- Sponsor's protocol ID
- 2018P001618
- Status last verified
- Nov 2021
- First submitted
- 18 Feb 2020
- Last updated
- 20 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Virtual Reality Technology as an Alternative to Pharmacological Sedation During Colonoscopy
- ClinicalTrials.gov ID
- NCT04349150
- Acronym / sponsor ID
- 2018P001618
- Conditions
- Colonoscopy
- Keywords
- Virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 10 May 2019 (actual)
- Primary completion
- 13 Jan 2020 (actual)
- Study completion
- 13 Jan 2020 (actual)
- First posted
- 16 Apr 2020 (actual)
- Results
- Posted 20 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual reality | Experimental | Device: Virtual realityParticipants on this arm will have their colonoscopy initiated under virtual reality instead of standard sedatives and narcotics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (18 years or older)
- Scheduled for screening or surveillance colonoscopy
- Has undergone at least 1 prior colonoscopy under conscious sedation
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual realityIntervention consists of providing virtual reality in place of standard sedatives and narcotics for a portion or the duration of the colonoscopy | Device | Virtual reality |
Primary outcome
Percentage of Participants Who Complete Colonoscopy Using Virtual Reality and no Pharmacological Rescue
Time frame: 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.
Number of Participants With Cecal Intubation
Time frame: 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.
5 secondary outcomes
Participant-reported Pain and Discomfort Levels
Time frame: This data will be collected within 60 minutes of completion of the colonoscopy
Participant Satisfaction
Time frame: 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
Time frame: This data will be collected within 60 minutes of completion of the colonoscopy
Endoscopist Satisfaction
Time frame: 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
Time frame: This data will be collected within 60 minutes of completion of the colonoscopy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel C Chung, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality in people with Colonoscopy, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Complete Colonoscopy Using Virtual Reality and no Pharmacological Rescue (time frame: This data will be collected within 60 minutes of completion of the colonoscopy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2021.