Virtual Reality Alternative to Pharmacological Sedation During Colonoscopy

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04349150

Enrollment

Registered

2020-04-16

Start date

2019-05-10

Completion date

2020-01-13

Last updated

2021-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonoscopy

Keywords

Virtual reality

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.

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.

Interventions

DEVICEVirtual reality

Intervention consists of providing virtual reality in place of standard sedatives and narcotics for a portion or the duration of the colonoscopy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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

Measure	Time frame	Description
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.
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)
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
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).
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).

Countries

United States

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.

Participants by arm

Arm	Count
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	27
Total	27

Baseline characteristics

Characteristic	Virtual Reality
Age, Continuous	63.9 Years STANDARD_DEVIATION 8.4
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants
Medical history potentially impacting exam difficulty Abdominal/pelvic surgery	11 Participants
Medical history potentially impacting exam difficulty None	15 Participants
Medical history potentially impacting exam difficulty Tortuous colon	1 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	2 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants
Race (NIH/OMB) White	24 Participants
Sex: Female, Male Female	14 Participants
Sex: Female, Male Male	13 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 27
other Total, other adverse events	0 / 27
serious Total, serious adverse events	0 / 27

Outcome results

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.