Procedural PainNCT06504602
Pain Elimination and Anxiety Control Through Experiential Virtual Reality
A study testing Active Virtual Reality and Passive Virtual Reality in people with Procedural Pain and Procedural Anxiety, run by Children's Hospital Los Angeles.
Trial summary
The goal of this clinical trial is to determine if active virtual reality is more effective than passive virtual reality and standard of care distraction in decreasing pain in children, from 8 to 21 years old, undergoing intravenous placement in emergency department. Read more about this study
- Who is it for?
- Ages 8 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Procedural Pain, Procedural Anxiety
- What is being tested?
- Active Virtual Reality and Passive Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 15 Mar 2025
- 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 8 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Children and adolescents 8-21 years old undergoing IV placement .
- Ability to understand study procedures and to comply with them for the entire length of the study.
- Participants and caregiver speaking English or Spanish.
Who cannot join
- Participants with psychiatric, developmental delay, visual or auditory deficits that would interfere with virtual reality gameplay (decision based on treating clinicians' evaluation).
- Participants receiving narcotics, opioids, or anxiolytics 8 hours prior (Tylenol and ibuprofen do not count).
- Participants with pain so significant that consent/assent is not possible (decision based on treating clinician evaluation).
- Critically ill Participants (ESI 1).
Trial locations and contacts
No sites are listed yet.
About this study
The goal of this clinical trial is to determine if active virtual reality is more effective than passive virtual reality and standard of care distraction in decreasing pain in children, from 8 to 21 years old, undergoing intravenous placement in emergency department. The main question[s] it aims to answer [is/are]:
- Will active virtual reality reduce pain score on Faces Pain Scale - revised and measure of heart rate during intravenous placement for children ages 8 years old to 21 years old more than passive virtual reality and standard of care?
- Will active virtual reality reduce anxiety score on Visual Analog Scale - revised and measure of heart rate during intravenous placement for children ages 8 years old to 21 years old more than passive virtual reality and standard of care?
Read more
If there is a comparison group: Researchers will compare active group to passive group and standard of care.
Participants will randomized into active virtual reality, passive virtual reality or standard of care arms.
- Conditions
- Procedural Pain, Procedural Anxiety
- Being tested
- Active Virtual Reality, Passive Virtual Reality
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Virtual RealityDevice
Active virtual reality group will play a game through a virtual environment.
Passive Virtual RealityDevice
Passive virtual reality group will watch a movie through a virtual environment.
| Study group | Role | What they receive |
|---|---|---|
| Active Virtual Reality | Experimental | Within the active virtual reality group virtual environment, participants will play the game Bearblast using Oculus Go Headset for patients 8-21 years old. In BearBlast, participants travel on a pre-set path through an interactive environment. Receives: Device: Active Virtual Reality |
| Passive Virtual Reality | Experimental | Within the passive virtual reality group virtual environment and age appropriate movie. Receives: Device: Passive Virtual Reality |
| Standard of Care | No intervention | Participants will receive standard of care distraction methods. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change from Baseline in Pain Scores on Faces Pain Scale - Revised after IV Placement
Pain score on Faces Pain Scale - Revised will be assessed 5 minutes before and immediately after procedure. The minimum score is 0, and the maximum score is 10. Higher scores correlate to a worse outcome (more pain).
Measured: 5 minutes before, immediately after procedure
Secondary outcomes (2)
Mean Change from Baseline in Anxiety Scores on Visual Analog Scale after IV Placement
Anxiety score on Visual Analog Scale will be assessed 5 minutes before and immediately after procedure. The minimum score is 0, and the maximum score is 100. Higher scores correlate to a worse outcome (more anxiety).
Measured: 5 minutes before, immediately after procedure
Mean Change from Baseline in Heart Rate after IV Placement
Heart Rate will be measured 5 minutes before, during, and immediately after procedure
Measured: 5 minutes before, during, and immediately after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start1 Sep 2024 (estimated)
- Primary completion15 Mar 2025 (estimated)
- Study completion15 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural PainStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matan Paret, Children's Hospital Los Angeles
- Investigators
- Matan Paret, MD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06504602
- Sponsor's protocol ID
- CHLA-24-00171
- Status last verified
- Jul 2024
- First submitted
- 11 Jul 2024
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Elimination and Anxiety Control Through Experiential Virtual Reality
- ClinicalTrials.gov ID
- NCT06504602
- Acronym / sponsor ID
- CHLA-24-00171
- Conditions
- Procedural Pain, Procedural Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 15 Mar 2025 (estimated)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 17 Jul 2024 (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.
The goal of this clinical trial is to determine if active virtual reality is more effective than passive virtual reality and standard of care distraction in decreasing pain in children, from 8 to 21 years old, undergoing intravenous placement in emergency department. The main question[s] it aims to answer [is/are]:
- Will active virtual reality reduce pain score on Faces Pain Scale - revised and measure of heart rate during intravenous placement for children ages 8 years old to 21 years old more than passive virtual reality and standard of care?
- Will active virtual reality reduce anxiety score on Visual Analog Scale - revised and measure of heart rate during intravenous placement for children ages 8 years old to 21 years old more than passive virtual reality and standard of care?
If there is a comparison group: Researchers will compare active group to passive group and standard of care.
Participants will randomized into active virtual reality, passive virtual reality or standard of care arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Virtual Reality | Experimental | Device: Active Virtual RealityWithin the active virtual reality group virtual environment, participants will play the game Bearblast using Oculus Go Headset for patients 8-21 years old. In BearBlast, participants travel on a pre-set path through an interactive environment. |
| Passive Virtual Reality | Experimental | Device: Passive Virtual RealityWithin the passive virtual reality group virtual environment and age appropriate movie. |
| Standard of Care | No intervention | –Participants will receive standard of care distraction methods. |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children and adolescents 8-21 years old undergoing IV placement .
Key exclusion criteria (4 listed)
- Participants with psychiatric, developmental delay, visual or auditory deficits that would interfere with virtual reality gameplay (decision based on treating clinicians' evaluation).
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 |
|---|---|---|
| Active Virtual RealityActive virtual reality group will play a game through a virtual environment. | Device | Active Virtual Reality |
| Passive Virtual RealityPassive virtual reality group will watch a movie through a virtual environment. | Device | Passive Virtual Reality |
Primary outcome
Mean Change from Baseline in Pain Scores on Faces Pain Scale - Revised after IV Placement
Time frame: 5 minutes before, immediately after procedure
Pain score on Faces Pain Scale - Revised will be assessed 5 minutes before and immediately after procedure. The minimum score is 0, and the maximum score is 10. Higher scores correlate to a worse outcome (more pain).
2 secondary outcomes
Mean Change from Baseline in Anxiety Scores on Visual Analog Scale after IV Placement
Time frame: 5 minutes before, immediately after procedure
Mean Change from Baseline in Heart Rate after IV Placement
Time frame: 5 minutes before, during, and immediately after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Matan Paret, MD principal investigator
Children's Hospital Los Angeles
Questions about this trial
What is this clinical trial studying?
A study testing Active Virtual Reality and Passive Virtual Reality in people with Procedural Pain and Procedural Anxiety, run by Children's Hospital Los Angeles.
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 4 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 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Matan Paret, MD (3233764793, mparet@chla.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change from Baseline in Pain Scores on Faces Pain Scale - Revised after IV Placement (time frame: 5 minutes before, immediately after procedure). 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 Jul 2024.