Patient SatisfactionNCT05701566
Use of Virtual Reality Technology as a Sedation Replacement During Colonoscopy
A study testing virtual reality headset and colonoscopy with standard sedation. in people with Patient Satisfaction, run by Sheba Medical Center at 1 site in Israel.
Trial summary
A pilot non-randomized controlled study examined whether the use of VR technology can serve as an appropriate substitute for sedation in a colonoscopy examination. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patient Satisfaction
- What is being tested?
- virtual reality headset and colonoscopy with standard sedation.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jun 2022to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 patients (≥18) with any elective indication for colonoscopy.
Who cannot join
- known seizures' disorders, cognitive, visual or auditory impairment.
- patients who were unable or unwilling to sign an informed consent.
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Gastroenterology department, Sheba Medical Center
Tel HaShomer
Ido Veisman, Dr., +97235307072, ido.veisman@sheba.health.gov.il
Revital Dvir, +97235307072, revital.dvir@sheba.health.gov.il
About this study
A pilot non-randomized controlled study examined whether the use of VR technology can serve as an appropriate substitute for sedation in a colonoscopy examination.
Read the detailed description
VR is an attention-distracting technology via visual and auditory signals by a computer-generated virtual engulfing environment. This technology has already been used in a variety of medical conditions and previous studies have demonstrated the benefit of using it as an additional tool for pain relief and as a substitute to sedation in invasive procedure. In this study we examined the use of VR as a substitute for sedation in colonoscopy. In this randomized control study, 60 patients were sequentially enrolled in a 1:1 ratio to either standard sedated colonoscopy or VR-unsedated procedure. The primary outcome was the overall satisfaction of patients who underwent unsedated colonoscopy with VR headset compared with patients who underwent standard sedation colonoscopy. Pain during the procedure, PDR, colonoscopy duration, post colonoscopy adverse events, post colonoscopy recovery and time-to-return to daily functions and turnaround time at the endoscopy unit were secondary outcomes.
- Conditions
- Patient Satisfaction
- Being tested
- virtual reality headset, colonoscopy with standard sedation.
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality headsetDevice
use of virtual reality headset during colonoscopy as a substitute to sedation.
colonoscopy with standard sedation.Other
use of standard sedation during colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| virtual reality group | Experimental | unsedated colonoscopy using virtual reality headset. Receives: Device: virtual reality headset |
| colonoscopy with standard sedation | Active comparator | standard sedated colonoscopy. Receives: Other: colonoscopy with standard sedation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall satisfaction of patients who underwent un-sedated colonoscopy with virtual reality (VR) headset compared with patients who underwent standard sedation colonoscopy.
Questionnaire (1 - not satisfied at all, 5 - very satisfied)
Measured: 1 day
Secondary outcomes (6)
Pain during the procedure
Questionnaire (1- severe pain, 5 - no pain at all)
Measured: 1 day
polyp detection rate (PDR)
number of polyps detected during colonoscopy
Measured: during colonoscopy procedure
Colonoscopy duration
in minutes starting at insertion of the colonoscope to the anus until final withdrawal
Measured: during colonoscopy procedure
Post colonoscopy adverse events
Questionnaire: Did you suffer from a general bad feeling after the test, including dizziness, nausea, abdominal pain (1 - no complaints at all, 5 - serious complaints)
Measured: 1 day
Time-to-return to daily activities (work, driving)
hours
Measured: 1 day
Turn-around time at the endoscopy Unit (overall duration of stay at the Endoscopy unit)
overall time at the unit
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start1 Jun 2022
- Primary completion1 Feb 2023
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- pilot randomized controled study
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ido Veisman, Dr., Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05701566
- Sponsor's protocol ID
- 8177-21-IV-CTIL
- Status last verified
- Jan 2023
- First submitted
- 18 Jan 2023
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Virtual Reality Technology as a Sedation Replacement During Colonoscopy
- ClinicalTrials.gov ID
- NCT05701566
- Acronym / sponsor ID
- 8177-21-IV-CTIL
- Conditions
- Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pilot non-randomized controlled study examined whether the use of VR technology can serve as an appropriate substitute for sedation in a colonoscopy examination.
Detailed description
VR is an attention-distracting technology via visual and auditory signals by a computer-generated virtual engulfing environment. This technology has already been used in a variety of medical conditions and previous studies have demonstrated the benefit of using it as an additional tool for pain relief and as a substitute to sedation in invasive procedure. In this study we examined the use of VR as a substitute for sedation in colonoscopy. In this randomized control study, 60 patients were sequentially enrolled in a 1:1 ratio to either standard sedated colonoscopy or VR-unsedated procedure. The primary outcome was the overall satisfaction of patients who underwent unsedated colonoscopy with VR headset compared with patients who underwent standard sedation colonoscopy. Pain during the procedure, PDR, colonoscopy duration, post colonoscopy adverse events, post colonoscopy recovery and time-to-return to daily functions and turnaround time at the endoscopy unit were secondary outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- pilot randomized controled study
| Arm | Type | Receives |
|---|---|---|
| virtual reality group | Experimental | Device: virtual reality headsetunsedated colonoscopy using virtual reality headset. |
| colonoscopy with standard sedation | Active comparator | Other: colonoscopy with standard sedation.standard sedated colonoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients (≥18) with any elective indication for colonoscopy.
Key exclusion criteria (3 listed)
- known seizures' disorders, cognitive, visual or auditory impairment.
- patients who were unable or unwilling to sign an informed consent.
- Pregnant women.
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 reality headsetuse of virtual reality headset during colonoscopy as a substitute to sedation. | Device | virtual reality group |
| colonoscopy with standard sedation.use of standard sedation during colonoscopy. | Other | colonoscopy with standard sedation |
Primary outcome
Overall satisfaction of patients who underwent un-sedated colonoscopy with virtual reality (VR) headset compared with patients who underwent standard sedation colonoscopy.
Time frame: 1 day
Questionnaire (1 - not satisfied at all, 5 - very satisfied)
6 secondary outcomes
Pain during the procedure
Time frame: 1 day
polyp detection rate (PDR)
Time frame: during colonoscopy procedure
Colonoscopy duration
Time frame: during colonoscopy procedure
Post colonoscopy adverse events
Time frame: 1 day
Time-to-return to daily activities (work, driving)
Time frame: 1 day
Turn-around time at the endoscopy Unit (overall duration of stay at the Endoscopy unit)
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
Ido Veisman, Dr. principal investigator
Sheba Medical Center
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 headset and colonoscopy with standard sedation. in people with Patient Satisfaction, run by Sheba Medical Center at 1 site in Israel.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 Apr 2023. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ido Veisman, Dr. (+97235307072 ext. 7072, Ido.Veisman@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall satisfaction of patients who underwent un-sedated colonoscopy with virtual reality (VR) headset compared with patients who underwent standard sedation colonoscopy. (time frame: 1 day). 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 10 Apr 2023.