Procedural SedationNCT03692390
Virtual Reality vs. Standard-of-Care for Comfort Before and After Sedation in the Emergency Department
A study testing Virtual Reality in people with Procedural Sedation, run by University of British Columbia at 1 site in Canada.
Trial summary
Children often need procedural sedation in the emergency department during painful procedures (such as reducing fractures). Virtual Reality (VR) is an immersive experience using sight, sound, and position sense. Using VR may enhance distraction during the painful procedure and may reduce attention to pain. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Procedural Sedation
- 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
- 64 participants
- Where
- 1 siteCanada
- Study dates
- 21 Sep 2018to 21 Sep 2019
- 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 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children age 6 to 16 years
- The managing physician determines need for procedural sedation
- Parents will sign a consent form and children will sign an assent form
Who cannot join
- Children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay, autism, inability to communicate)
- Triage category 1 (resuscitation)
- Facial features or injury prohibiting wearing the VR goggles
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
BC Children's Hospital
Vancouver, British Columbia, V6H 3N1
Ran D Goldman, MD, (604) 875-2346 ext. 7333, rgoldman@bc.cw.ca
About this study
Official title: A Pragmatic Randomized Controlled Trial of Virtual Reality vs. Standard-of-Care for Comfort Before and After Sedation in the Emergency Department
Children often need procedural sedation in the emergency department during painful procedures (such as reducing fractures).
Virtual Reality (VR) is an immersive experience using sight, sound, and position sense. Using VR may enhance distraction during the painful procedure and may reduce attention to pain. VR may also reduce anxiety during sedation induction by reducing providing an alternative stimulus.
This study will randomize children (6 - 16 years old) to receive Virtual Reality or standard of care while undergoing procedural sedation. Investigators will measure heart rate, blood pressure, satisfaction (child, parent, provider), amount of sedatives used and compare between the two groups.
- Conditions
- Procedural Sedation
- Being tested
- Virtual Reality
- Keywords
- Virtual Reality, Heart Rate, Blood Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
Participants wear a Virtual Reality headset that consists of a ASUS phone and a VOX+ Z3 3D Virtual Reality Headset. The phone runs the VR Roller Coaster app to produce the virtual environment.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Experimental | Participants are distracted by wearing the virtual reality headset and watching a roller coaster app while undergoing procedural sedation Receives: Device: Virtual Reality |
| Standard-of-Care | No intervention | Participants are distracted with Standard-of-Care by doctors, nurses, nurse practitioners, child life specialists and/or parents. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Heart Rate as measured by heart rate monitor
The heart rate monitor will consistently display participant heart rate. Heart rate will be recorded at 1 minute intervals. The difference in heart rate from recommended mean heart rate based on age will be calculated and compared between groups.
Measured: During the procedure at 1 minute intervals
Change in Blood Pressure as measured by blood pressure monitor
The blood pressure monitor will display participant blood pressure. Blood pressure will be recorded at 1 minute intervals. The difference in blood pressure from recommended mean blood pressure (systolic and diastolic) based on age will be calculated and compared between groups.
Measured: During the procedure at 1 minute intervals
Secondary outcomes (7)
Emergence Phenomenon as measured by yes/no questions regarding participant experience.
Patients will be asked whether they experienced nightmares, day-dreaming, or feeling unwell. Number of patients who experienced these negative emergence phenomenon will be tabulated and compared across groups.
Measured: Immediately after the procedure and by phone the next day
Satisfaction among Children by global rating scale
Children will be asked "On a scale of 0-10, how did the procedure go?" A score of 0 represents not very well and a score of 10 represents very well.
Measured: Immediately after the procedure
Satisfaction among Guardians by global rating scale
Guardians will be asked "On a scale of 0-10, how did the procedure go?" A score of 0 represents not very well and a score of 10 represents very well.
Measured: Immediately after the procedure
Satisfaction among Emergency Staff by global rating scale
Emergency Staff will be asked "How satisfied are you with how the procedure went?" A score of 0 represents not very well and a score of 10 represents very well.
Measured: Immediately after the procedure
Type and dose of medication
Amount of medication and what medications were used will be gathered from the nursing notes.
Measured: Intraoperative
Time difference of the procedure
Time the procedure takes to complete with or without VR will be recorded to determine if there is any difference.
Measured: Intraoperative
Length of stay in the Emergency Department
Length of stay in the Emergency Department will also be recorded. This will be determined by the intake time noted by triage and the discharge time as witnessed by research assistant or, if unseen, by the time noted on the discharge paperwork.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start21 Sep 2018
- Primary completion21 Sep 2019 (estimated)
- Study completion21 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural SedationStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ran Goldman, University of British Columbia
- Investigators
- Ran Goldman, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692390
- Sponsor's protocol ID
- H18-01949
- Status last verified
- Sep 2018
- First submitted
- 20 Sep 2018
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Randomized Controlled Trial of Virtual Reality vs. Standard-of-Care for Comfort Before and After Sedation in the Emergency Department
- ClinicalTrials.gov ID
- NCT03692390
- Acronym / sponsor ID
- H18-01949
- Conditions
- Procedural Sedation
- Keywords
- Virtual Reality, Heart Rate, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 21 Sep 2018 (actual)
- Primary completion
- 21 Sep 2019 (estimated)
- Study completion
- 21 Sep 2019 (estimated)
- First posted
- 2 Oct 2018 (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.
Children often need procedural sedation in the emergency department during painful procedures (such as reducing fractures).
Virtual Reality (VR) is an immersive experience using sight, sound, and position sense. Using VR may enhance distraction during the painful procedure and may reduce attention to pain. VR may also reduce anxiety during sedation induction by reducing providing an alternative stimulus.
This study will randomize children (6 - 16 years old) to receive Virtual Reality or standard of care while undergoing procedural sedation. Investigators will measure heart rate, blood pressure, satisfaction (child, parent, provider), amount of sedatives used and compare between the two groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Device: Virtual RealityParticipants are distracted by wearing the virtual reality headset and watching a roller coaster app while undergoing procedural sedation |
| Standard-of-Care | No intervention | –Participants are distracted with Standard-of-Care by doctors, nurses, nurse practitioners, child life specialists and/or parents. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children age 6 to 16 years
- The managing physician determines need for procedural sedation
- Parents will sign a consent form and children will sign an assent form
Key exclusion criteria (3 listed)
- Children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay, autism, inability to communicate)
- Triage category 1 (resuscitation)
- Facial features or injury prohibiting wearing the VR goggles
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 RealityParticipants wear a Virtual Reality headset that consists of a ASUS phone and a VOX+ Z3 3D Virtual Reality Headset. The phone runs the VR Roller Coaster app to produce the virtual environment. | Device | Virtual Reality |
Primary outcome
Change in Heart Rate as measured by heart rate monitor
Time frame: During the procedure at 1 minute intervals
The heart rate monitor will consistently display participant heart rate. Heart rate will be recorded at 1 minute intervals. The difference in heart rate from recommended mean heart rate based on age will be calculated and compared between groups.
Change in Blood Pressure as measured by blood pressure monitor
Time frame: During the procedure at 1 minute intervals
The blood pressure monitor will display participant blood pressure. Blood pressure will be recorded at 1 minute intervals. The difference in blood pressure from recommended mean blood pressure (systolic and diastolic) based on age will be calculated and compared between groups.
7 secondary outcomes
Emergence Phenomenon as measured by yes/no questions regarding participant experience.
Time frame: Immediately after the procedure and by phone the next day
Satisfaction among Children by global rating scale
Time frame: Immediately after the procedure
Satisfaction among Guardians by global rating scale
Time frame: Immediately after the procedure
Satisfaction among Emergency Staff by global rating scale
Time frame: Immediately after the procedure
Type and dose of medication
Time frame: Intraoperative
Time difference of the procedure
Time frame: Intraoperative
Length of stay in the Emergency Department
Time frame: Intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
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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.
Ran Goldman, MD principal investigator
University of British Columbia
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 Procedural Sedation, run by University of British Columbia at 1 site in Canada.
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 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 2 Oct 2018. 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 Canada. 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 Ran Goldman, MD (604-875-2345 ext. 7333, rgoldman@cw.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Heart Rate as measured by heart rate monitor (time frame: During the procedure at 1 minute intervals). 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 2 Oct 2018.