Children Requiring IV PlacementNCT04291404
Virtual Reality-based Distraction to Reduce Distress in the Pediatric Emergency Department
A study testing Virtual Reality Distraction in people with Children Requiring IV Placement, run by University of Alberta at 1 site in Canada.
Trial summary
Needle procedures, such as intravenous (IV) insertions, are among the most commonly performed procedures for children needing medical care. IV insertions are often a painful and stressful experience for both children and their parents/ caregivers. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Children Requiring IV Placement
- What is being tested?
- Virtual Reality Distraction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteCanada
- Study dates
- 28 Sep 2020to 12 Feb 2022
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- child aged 6-17 years
- requires IV placement
- will receive topical anesthetic cream for IV placement
Who cannot join
- medically unstable (CTAS 1, requires immediate IV insertion)
- unconscious or not fully alert
- visual, auditory or cognitive or mental health issues precluding safe interaction with the VR intervention
- conditions that could be exacerbated by the VR environment (as reported by the family), such as: (i) current symptomatic nausea / vomiting / dizziness / migraine; (ii) history of psychosis / hallucinations / epilepsy
- presence of an infection / injury which could contaminate the VR intervention equipment (as determined by the healthcare team) including but not limited to: (i) open wounds / infections of the head and neck area; (ii) suspected or confirmed methicillin-resistant Staphylococcus aureus (MRSA) colonization
- screens positive for 'influenza-like illness' (ILI) as per the current SCH ED screening criteria
- child or parental language barrier precluding the ability to understand and complete study assessments, in the absence of a native language translator
- previous enrollment in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Virtual Reality-based Distraction for Venipuncture-related Distress in Children
Needle procedures, such as intravenous (IV) insertions, are among the most commonly performed procedures for children needing medical care. IV insertions are often a painful and stressful experience for both children and their parents/ caregivers. Pediatric pain and distress that is not adequately treated may lead to a frightened and uncooperative child, repeated IV attempts and overall frustration with care for the family and clinical team.
Distraction therapy is a common psychological strategy which involves engaging children in a cognitive task or activity in order to divert attention away from painful stimuli. Given children's growing enthusiasm for novel technology, the investigators propose that an immersive virtual reality (VR) experience may provide an effective means of distraction for children undergoing IV insertions.
Read the detailed description
Objectives: The investigators' primary objective is to compare the reduction of distress with the use of distraction (via the VR intervention) versus current standard of care in children aged 6 to 17 years who are undergoing IV placement. The secondary objectives are to compare (a) the reduction of pain; (b) the reduction of fear; (c) the reduction of parental/caregiver anxiety; and (d) parental/caregiver and nurse satisfaction with the procedure in the intervention versus control arms; and (e) to assess the safety of using VR intervention in children aged 6 to17 years who are undergoing IV placement.
Research Plan: The investigators will conduct a randomized controlled trial consisting of a control arm receiving departmental standard of care and an intervention arm which will include the addition of an immersive VR experience to current standard of care. Children 6 to 17 years of age who are undergoing IV insertions in the Stollery Children's Hospital emergency department will be considered for enrollment into the study. Approximately 80 families will be recruited over a one-year period.
Study Intervention and Comparison: The VR intervention will aim to provide distraction by immersing the child in an artificial 3-dimensional environment that will engage them for the duration of the IV procedure. The child will wear a head-mounted display ("VR goggles") that will allow them to explore the virtual world through their own visual perspective in 360-degrees. A small handheld controller (optional) can be used to interact with the virtual environment and change settings. The VR goggles will occlude the patient's view of the treatment room, and a pair of noise-cancelling headphones (optional) can be used to further block out ambient hospital sounds. Together, this will provide the child with a unique vivid experience of being fully immersed or "present" inside the 3D virtual world. The control group will receive departmental standard of care which will include topical anesthetic cream (mandatory) and may include parent/caregiver support, child life services, nursing support, etc (at the discretion of the ED clinical care team and the family). At present, there is no single established distraction therapy or routine that is consistently employed for IV procedures within the study site ED. Thus, for pragmatic and ethical considerations, it is felt that the new study VR intervention should be compared to what is currently already in practice (ie. standard of care). Of note, other forms of technology (e.g. smart phones, tablets) will not be prohibited in the control group, if the family chooses to offer them. Due to ethical and pragmatic considerations, children in both groups must receive topical anesthetic cream for IV placement, as it is known to be effective and considered standard of care within the study hospital.
Study Impact: The use of immersive VR technology has previously shown promise in numerous healthcare settings. However, there is still a need for robust evidence regarding its effectiveness in treating pediatric distress associated with IV procedures, particularly in the emergency department. Results of this randomized controlled trial could inform an evidence-based strategy for the management of pediatric distress, which could be used in settings with and without child life specialists.
- Conditions
- Children Requiring IV Placement
- Being tested
- Virtual Reality Distraction
- Keywords
- Pain, Distress, Virtual Reality, Distraction Therapy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality DistractionDevice
Distraction therapy using a Virtual Reality (VR) device
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (Control) Arm | No intervention | Standard of care treatment, which may include a combination of the following, at the discretion of the treating team and family: parent/ caregiver support, child life services, healthcare provider support, etc. |
| Intervention Arm | Experimental | Addition of distraction via an immersive, interactive VR experience to Standard of Care Receives: Device: Virtual Reality Distraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child's total distress score during the IV procedure
Two RAs will independently observe a videotape of each child and use the Observational Scale of Behavioral Distress - Revised (OSBD-R) to assess children's response behaviors to pain. (0 = no distress, 23.5 = maximum distress)
Measured: During the IV placement procedure
Secondary outcomes (8)
Child's pain score during the IV procedure
Self reported by child using an 11-point verbal Numerical Rating Scale (vNRS) ranging from 0, which indicates no pain, to 10, which indicates the worst possible pain
Measured: Immediately after IV placement
Child's Fear
Self reported by child using the Children's Fear Scale (CFS). This is a five face scale ranging from 0= not scared at all to 4= most scared possible.
Measured: Immediately after IV placement
Parental anxiety
Parent will fill out the State Trait Anxiety Inventory - State Scale Revised Version (STAI-S, Form Y), a validated and commonly used version of STAI, which has improved psychometric properties. The score ranges from 20 to 80, with 80 indicating maximum anxiety.
Measured: Immediately after IV placement
Parent/ Caregiver Satisfaction
Self-reported using a 5-point likert scale, ranging from 1 "Not at all satisfied" to 5 "Very satisfied".
Measured: Immediately following the IV procedure
Nurse Satisfaction
Self-reported using a 5-point likert scale, ranging from 1 "Not at all satisfied" to 5 "Very satisfied".
Measured: Immediately following the IV procedure
Child Satisfaction
For children, we will use a a 5-point likert scale ranging from 1 "Not at all happy" to 5 "Very happy".
Measured: Immediately following the IV procedure
Frequency of adverse events related to the study intervention
Determined by assessing the frequency of adverse events post intervention. Nausea will be self-rated by children immediately following the intervention, using the Baxter Retching Faces (BARF) scale. This is a six face scale ranging from 0= no nausea at all to 10= most nausea it is possible to feel.
Measured: During the IV procedure
Child's distress during the IV procedure
In addition to assessing child distress via the Observational Scale of Behavioral Distress - Revised (primary outcome), we will also ask children to self-report their distress on an 11-point numerical rating scale ranging from 0 "no distress" to 10 "the most distress you can imagine having". While easy to use and previously employed, this scale has not been validated or compared to the validated Observational Scale of Behavioral Distress - Revised.
Measured: Immediately after IV placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start28 Sep 2020
- Primary completion12 Feb 2022
- Study completion12 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Children Requiring IV PlacementStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samina Ali, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04291404
- Sponsor's protocol ID
- Pro00095418
- Status last verified
- Oct 2021
- First submitted
- 20 Feb 2020
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ali S, Hudson S, Rajagopal M, Stinson JN, Gourlay K, Ma K, Candelaria P, Vandermeer B, Felkar B, Schreiner K, Proctor A, Hartling L. A Randomized Controlled Trial of Commercially Available Virtual Reality for Intravenous Cannulation-Related Distress in Children. J Pediatr. 2026 Jan;288:114803. doi: 10.1016/j.jpeds.2025.114803. Epub 2025 Sep 15.
PubMed 40962105Ali S, Rajagopal M, Stinson J, Ma K, Vandermeer B, Felkar B, Schreiner K, Proctor A, Plume J, Hartling L. Virtual reality-based distraction for intravenous insertion-related distress in children: a study protocol for a randomised controlled trial. BMJ Open. 2022 Mar 30;12(3):e057892. doi: 10.1136/bmjopen-2021-057892.
PubMed 35354617
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Virtual Reality-based Distraction for Venipuncture-related Distress in Children
- ClinicalTrials.gov ID
- NCT04291404
- Acronym / sponsor ID
- Pro00095418
- Conditions
- Children Requiring IV Placement
- Keywords
- Pain, Distress, Virtual Reality, Distraction Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 12 Feb 2022 (actual)
- Study completion
- 12 Feb 2022 (actual)
- First posted
- 2 Mar 2020 (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.
Needle procedures, such as intravenous (IV) insertions, are among the most commonly performed procedures for children needing medical care. IV insertions are often a painful and stressful experience for both children and their parents/ caregivers. Pediatric pain and distress that is not adequately treated may lead to a frightened and uncooperative child, repeated IV attempts and overall frustration with care for the family and clinical team.
Distraction therapy is a common psychological strategy which involves engaging children in a cognitive task or activity in order to divert attention away from painful stimuli. Given children's growing enthusiasm for novel technology, the investigators propose that an immersive virtual reality (VR) experience may provide an effective means of distraction for children undergoing IV insertions.
Detailed description
Objectives: The investigators' primary objective is to compare the reduction of distress with the use of distraction (via the VR intervention) versus current standard of care in children aged 6 to 17 years who are undergoing IV placement. The secondary objectives are to compare (a) the reduction of pain; (b) the reduction of fear; (c) the reduction of parental/caregiver anxiety; and (d) parental/caregiver and nurse satisfaction with the procedure in the intervention versus control arms; and (e) to assess the safety of using VR intervention in children aged 6 to17 years who are undergoing IV placement.
Research Plan: The investigators will conduct a randomized controlled trial consisting of a control arm receiving departmental standard of care and an intervention arm which will include the addition of an immersive VR experience to current standard of care. Children 6 to 17 years of age who are undergoing IV insertions in the Stollery Children's Hospital emergency department will be considered for enrollment into the study. Approximately 80 families will be recruited over a one-year period.
Study Intervention and Comparison: The VR intervention will aim to provide distraction by immersing the child in an artificial 3-dimensional environment that will engage them for the duration of the IV procedure. The child will wear a head-mounted display ("VR goggles") that will allow them to explore the virtual world through their own visual perspective in 360-degrees. A small handheld controller (optional) can be used to interact with the virtual environment and change settings. The VR goggles will occlude the patient's view of the treatment room, and a pair of noise-cancelling headphones (optional) can be used to further block out ambient hospital sounds. Together, this will provide the child with a unique vivid experience of being fully immersed or "present" inside the 3D virtual world. The control group will receive departmental standard of care which will include topical anesthetic cream (mandatory) and may include parent/caregiver support, child life services, nursing support, etc (at the discretion of the ED clinical care team and the family). At present, there is no single established distraction therapy or routine that is consistently employed for IV procedures within the study site ED. Thus, for pragmatic and ethical considerations, it is felt that the new study VR intervention should be compared to what is currently already in practice (ie. standard of care). Of note, other forms of technology (e.g. smart phones, tablets) will not be prohibited in the control group, if the family chooses to offer them. Due to ethical and pragmatic considerations, children in both groups must receive topical anesthetic cream for IV placement, as it is known to be effective and considered standard of care within the study hospital.
Study Impact: The use of immersive VR technology has previously shown promise in numerous healthcare settings. However, there is still a need for robust evidence regarding its effectiveness in treating pediatric distress associated with IV procedures, particularly in the emergency department. Results of this randomized controlled trial could inform an evidence-based strategy for the management of pediatric distress, which could be used in settings with and without child life specialists.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (Control) Arm | No intervention | –Standard of care treatment, which may include a combination of the following, at the discretion of the treating team and family: parent/ caregiver support, child life services, healthcare provider support, etc. |
| Intervention Arm | Experimental | Device: Virtual Reality DistractionAddition of distraction via an immersive, interactive VR experience to Standard of Care |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- child aged 6-17 years
- requires IV placement
- will receive topical anesthetic cream for IV placement
Key exclusion criteria (8 listed)
- medically unstable (CTAS 1, requires immediate IV insertion)
- unconscious or not fully alert
- visual, auditory or cognitive or mental health issues precluding safe interaction with the VR intervention
- conditions that could be exacerbated by the VR environment (as reported by the family), such as: (i) current symptomatic nausea / vomiting / dizziness / migraine; (ii) history of psychosis / hallucinations / epilepsy
- presence of an infection / injury which could contaminate the VR intervention equipment (as determined by the healthcare team) including but not limited to: (i) open wounds / infections of the head and neck area; (ii) suspected or confirmed methicillin-resistant Staphylococcus aureus (MRSA) colonization
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 DistractionDistraction therapy using a Virtual Reality (VR) device | Device | Intervention Arm |
Primary outcome
Child's total distress score during the IV procedure
Time frame: During the IV placement procedure
Two RAs will independently observe a videotape of each child and use the Observational Scale of Behavioral Distress - Revised (OSBD-R) to assess children's response behaviors to pain. (0 = no distress, 23.5 = maximum distress)
8 secondary outcomes
Child's pain score during the IV procedure
Time frame: Immediately after IV placement
Child's Fear
Time frame: Immediately after IV placement
Parental anxiety
Time frame: Immediately after IV placement
Parent/ Caregiver Satisfaction
Time frame: Immediately following the IV procedure
Nurse Satisfaction
Time frame: Immediately following the IV procedure
Child Satisfaction
Time frame: Immediately following the IV procedure
Frequency of adverse events related to the study intervention
Time frame: During the IV procedure
Child's distress during the IV procedure
Time frame: Immediately after IV placement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Derived from this study: PubMed 40962105Ali S, Hudson S, Rajagopal M, Stinson JN, Gourlay K, Ma K, Candelaria P, Vandermeer B, Felkar B, Schreiner K, Proctor A, Hartling L. A Randomized Controlled Trial of Commercially Available Virtual Reality for Intravenous Cannulation-Related Distress in Children. J Pediatr. 2026 Jan;288:114803. doi: 10.1016/j.jpeds.2025.114803. Epub 2025 Sep 15.
- Derived from this study: PubMed 35354617Ali S, Rajagopal M, Stinson J, Ma K, Vandermeer B, Felkar B, Schreiner K, Proctor A, Plume J, Hartling L. Virtual reality-based distraction for intravenous insertion-related distress in children: a study protocol for a randomised controlled trial. BMJ Open. 2022 Mar 30;12(3):e057892. doi: 10.1136/bmjopen-2021-057892.
- Individual participant dataSharing planned: No
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.
Samina Ali, MD principal investigator
University of Alberta
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 Distraction in people with Children Requiring IV Placement, run by University of Alberta 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 8 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: finished, as of the sponsor's last update on 31 Mar 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child's total distress score during the IV procedure (time frame: During the IV placement procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04291404, which also lists 2 linked publications.
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 31 Mar 2022.