VaccinationNCT03693469
Virtual Reality vs. Standard-of-Care for Comfort During Immunizations in Children
A study testing Virtual Reality in people with Vaccination, run by University of British Columbia at 1 site in Canada.
Trial summary
Children need routine immunizations which can be a painful procedure associated with pain and anxiety. This is particularly true of children visiting the children's hospital to visit relatives during flu season. No topical anesthetic or oral analgesia is commonly used. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Vaccination
- What is being tested?
- Virtual Reality
- Type of treatment
- Vaccines, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2018to 1 Oct 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
- Patients arriving to the immunization clinic for immunization.
- 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)
- Facial features or injury prohibiting wearing the VR goggles
- VR system may interfere with immunization
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, 604-875-2000, rgoldman@cw.bc.ca
About this study
Official title: A Pragmatic Randomized Controlled Trial of Virtual Reality vs. Standard-of-Care for Comfort During Immunizations in Children
Children need routine immunizations which can be a painful procedure associated with pain and anxiety. This is particularly true of children visiting the children's hospital to visit relatives during flu season. No topical anesthetic or oral analgesia is commonly used.
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.
This study will randomize children (6 - 16 years old) to receive Virtual Reality or standard of care while receiving immunizations. Investigators will measure pain, anxiety and satisfaction.
- Conditions
- Vaccination
- Being tested
- Virtual Reality
- Keywords
- Virtual Reality, Pain, Anxiety
- Medical subject headings
- Pain, Anxiety Disorders
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 during immunization. Receives: Device: Virtual Reality |
| Control (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.
Pain using the Faces Pain Scale - Revised
Level of pain as reported by children using Faces Pain Scale - Revised. The scale includes six faces that represent progressively more intense features of pain. Children point to the face that best represents their current level of pain. The minimum score is 0 (representing least pain) and the maximum score is 10 (representing greater pain). The scale increase in increments of 2.
Measured: Pain is reported by children immediately following completion of the immunization (within two minutes post-immunization). This scale should take less than one minute to complete.
Secondary outcomes (4)
Anxiety using the Venham Situational Anxiety Score
Level of Situational Anxiety as reported by children using the Venham Situational Anxiety Score. This scale includes 8 sets of 2 images of children which represent differing levels of anxiety. Children point to the child that best represents them in that instance. In each set of 2 images of children, one represents greater anxiety (scored as 1) and one represents lesser anxiety (scored as 0). The points from each set of images are totaled. The minimum score is 0 (least anxious) and maximum score is 8 (most anxious).
Measured: Anxiety is reported by children immediately following completion of the immunization (within two minutes post-immunization). This scale should take less than one minute to complete.
Patient Satisfaction determined by Global Rating Scale
Satisfaction from the procedure is determined by asking 4 questions on a global rating scale. This scale goes from 0-10 where 0 represents "not very much" and 10 represents "very much." Questions are developed from previous virtual reality research. "Overall, how satisfied are you with pain management during plastic surgery?" "Overall, how satisfied are you with anxiety management during plastic surgery?" "To what extent did you feel like you went into the virtual world?" "How much fun did you have while playing in the virtual world?" These questions will be analyzed individually not summed.
Measured: Satisfaction question is reported by children immediately following completion of the immunization (within 5 minutes post immunization)
Medication Dose
How much topical or local anesthetics are used and when they are used (24 hour time); how much sedatives are used and when they are used (24 hour time); how much analgesics are used and when they are used (24 hour time).
Measured: These will be recorded during the procedure and immediately following the procedure using the patient chart
Length of time of procedure
Time in minutes from readiness for procedure (availability of child, staff and equipment) until completion of procedure (healthcare practitioner does not need to touch the patient anymore)
Measured: This will be documented during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start1 Oct 2018
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaccinationStudies 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
- NCT03693469
- Sponsor's protocol ID
- H18-01851
- Status last verified
- Jan 2019
- First submitted
- 20 Sep 2018
- Last updated
- 18 Jan 2019
- 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 18 Jan 2019. 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 During Immunizations in Children
- ClinicalTrials.gov ID
- NCT03693469
- Acronym / sponsor ID
- H18-01851
- Conditions
- Vaccination
- Keywords
- Virtual Reality, Pain, Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Oct 2019 (estimated)
- First posted
- 3 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 need routine immunizations which can be a painful procedure associated with pain and anxiety. This is particularly true of children visiting the children's hospital to visit relatives during flu season. No topical anesthetic or oral analgesia is commonly used.
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.
This study will randomize children (6 - 16 years old) to receive Virtual Reality or standard of care while receiving immunizations. Investigators will measure pain, anxiety and satisfaction.
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 during immunization. |
| Control (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
- Patients arriving to the immunization clinic for immunization.
- 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)
- Facial features or injury prohibiting wearing the VR goggles
- VR system may interfere with immunization
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
Pain using the Faces Pain Scale - Revised
Time frame: Pain is reported by children immediately following completion of the immunization (within two minutes post-immunization). This scale should take less than one minute to complete.
Level of pain as reported by children using Faces Pain Scale - Revised. The scale includes six faces that represent progressively more intense features of pain. Children point to the face that best represents their current level of pain. The minimum score is 0 (representing least pain) and the maximum score is 10 (representing greater pain). The scale increase in increments of 2.
4 secondary outcomes
Anxiety using the Venham Situational Anxiety Score
Time frame: Anxiety is reported by children immediately following completion of the immunization (within two minutes post-immunization). This scale should take less than one minute to complete.
Patient Satisfaction determined by Global Rating Scale
Time frame: Satisfaction question is reported by children immediately following completion of the immunization (within 5 minutes post immunization)
Medication Dose
Time frame: These will be recorded during the procedure and immediately following the procedure using the patient chart
Length of time of procedure
Time frame: This will be documented during the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2019.
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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 Vaccination, 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 18 Jan 2019. 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?
Pain using the Faces Pain Scale - Revised (time frame: Pain is reported by children immediately following completion of the immunization (within two minutes post-immunization). This scale should take less than one minute to complete.). 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 18 Jan 2019.