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OpenTrials
Completed

NCT Number: NCT04349150

Virtual Reality 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.

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Key information

Conditions

Colonoscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Participant-reported Pain and Discomfort Levels

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

A Pilot Study of Virtual Reality Technology as an Alternative to Pharmacological Sedation During Colonoscopy

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 16, 2020
Registry last updated
Dec 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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