Acute PainNCT06795126
Little NIRVANA for Pediatric Pain and Anxiety
A study testing Little NIRVANA in people with Acute Pain and Procedural Anxiety, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
The aim of this study is to test the feasibility of using Little NIRVANA (augmented reality (AR)) for managing anxiety and pain for children 2-8 years old during hospital emergency peripheral intravenous (PIV) insertions. Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Acute Pain, Procedural Anxiety, Pediatric ALL
- What is being tested?
- Little NIRVANA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2025to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 2 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All patients undergoing PIV line placement (peripheral IV order placed while patient is in the ED);
- Patients 2-8 years of age (inclusive)
Who cannot join
- Non-English speaking (Little NIRVANA is currently only available in English and Dutch);
- those for whom utilizing AR is deemed not feasible by the attending ED physician (e.g., critical illness)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Augmented Reality for Managing Pediatric Anxiety and Pain During Disasters - A Randomized Pilot Feasibility Study
The aim of this study is to test the feasibility of using Little NIRVANA (augmented reality (AR)) for managing anxiety and pain for children 2-8 years old during hospital emergency peripheral intravenous (PIV) insertions. The investigators hypothesize that Little NIRVANA plus a numbing cream will reduce pain and anxiety for patients undergoing PIV placement in the emergency department (ED) when compared to the cream alone. It is anticipated that using the Little NIRVANA will not increase the ED length of stay, failed PIV placement attempts, or the need for additional intervention.
Read the detailed description
This is a two-group randomized clinical trial of 65 dyads of subjects and their parent and 65 proceduralists. Children will be randomly assigned to either the Little NIRVANA intervention group or a standard of care control group. Legal guardians of children in both groups will answer questions about their child's prior history of needle procedures, current pain/anxiety, medications taken prior to ED arrival, and video game experience. Children assigned to the intervention will play the game during the PIV placement, while children in the control group will receive the standard of care. The proceduralist performing the PIV placement and the parent will answer questions after the PIV placement about their perception of the child's pain and anxiety and questions about the Little NIRVANA experience for those children who were in the intervention group. This study has one visit that is completed during their ED stay.
- Conditions
- Acute Pain, Procedural Anxiety, Pediatric ALL, Emergency Medicine, IV Access
- Being tested
- Little NIRVANA
- Keywords
- AR, Pain, Anxiety, Augmented Reality, Distraction
- Medical subject headings
- Acute Pain, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Little NIRVANAOther
Also called Augmented Reality
Augmented reality (AR) digital solution where children interact with the game using a magic wand
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants will receive a topical anesthetic cream and will use Little NIRVANA AR digital solution during PIV line placement Receives: Other: Little NIRVANA |
| Control | No intervention | Treatment as usual - participants will receive a topical anesthetic cream but will not use the Little NIRVANA (other distraction methods available in the ED are allowed) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proxy reported pain
0-10 Numerical Rating Scale (NRS) (proxy reported by parent and proceduralist), 0(minimum)-10(maximum), with higher score indicating worse pain.
Measured: Immediately following the PIV line placement
Proxy reported anxiety
0-10 Numerical Rating Scale (NRS) (proxy reported by parent and proceduralist), 0(minimum )-10(maximum), with higher score indicating worse anxiety.
Measured: Immediately following the PIV line placement
Secondary outcomes (1)
Proxy reported AR experience
0-10 Numerical Rating Scale (NRS) (proxy-reported - intervention arm only), 0(minimum )-10(maximum), with higher score meaning better outcome. Asked for fun, engagement, and satisfaction with the AR.
Measured: Immediately following the PIV line placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start15 Nov 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe 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
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven, Health Resources and Services Administration (HRSA)
- Responsible party
- Principal investigator, Jonathan Chang, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795126
- Sponsor's protocol ID
- STUDY00004268
- Other IDs
- U1IMC43532
- Status last verified
- Aug 2026
- First submitted
- 22 Jan 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmented Reality for Managing Pediatric Anxiety and Pain During Disasters - A Randomized Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT06795126
- Acronym / sponsor ID
- STUDY00004268
- Conditions
- Acute Pain, Procedural Anxiety, Pediatric ALL, Emergency Medicine, IV Access
- Keywords
- AR, Pain, Anxiety, Augmented Reality, Distraction
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Collaborators
- KU Leuven, Health Resources and Services Administration (HRSA)
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 27 Jan 2025 (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 aim of this study is to test the feasibility of using Little NIRVANA (augmented reality (AR)) for managing anxiety and pain for children 2-8 years old during hospital emergency peripheral intravenous (PIV) insertions. The investigators hypothesize that Little NIRVANA plus a numbing cream will reduce pain and anxiety for patients undergoing PIV placement in the emergency department (ED) when compared to the cream alone. It is anticipated that using the Little NIRVANA will not increase the ED length of stay, failed PIV placement attempts, or the need for additional intervention.
Detailed description
This is a two-group randomized clinical trial of 65 dyads of subjects and their parent and 65 proceduralists. Children will be randomly assigned to either the Little NIRVANA intervention group or a standard of care control group. Legal guardians of children in both groups will answer questions about their child's prior history of needle procedures, current pain/anxiety, medications taken prior to ED arrival, and video game experience. Children assigned to the intervention will play the game during the PIV placement, while children in the control group will receive the standard of care. The proceduralist performing the PIV placement and the parent will answer questions after the PIV placement about their perception of the child's pain and anxiety and questions about the Little NIRVANA experience for those children who were in the intervention group. This study has one visit that is completed during their ED stay.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Little NIRVANAParticipants will receive a topical anesthetic cream and will use Little NIRVANA AR digital solution during PIV line placement |
| Control | No intervention | –Treatment as usual - participants will receive a topical anesthetic cream but will not use the Little NIRVANA (other distraction methods available in the ED are allowed) |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- All patients undergoing PIV line placement (peripheral IV order placed while patient is in the ED);
- Patients 2-8 years of age (inclusive)
Key exclusion criteria (2 listed)
- Non-English speaking (Little NIRVANA is currently only available in English and Dutch);
- those for whom utilizing AR is deemed not feasible by the attending ED physician (e.g., critical illness)
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 |
|---|---|---|
| Little NIRVANAAlso: Augmented RealityAugmented reality (AR) digital solution where children interact with the game using a magic wand | Other | Intervention Group |
Primary outcome
Proxy reported pain
Time frame: Immediately following the PIV line placement
0-10 Numerical Rating Scale (NRS) (proxy reported by parent and proceduralist), 0(minimum)-10(maximum), with higher score indicating worse pain.
Proxy reported anxiety
Time frame: Immediately following the PIV line placement
0-10 Numerical Rating Scale (NRS) (proxy reported by parent and proceduralist), 0(minimum )-10(maximum), with higher score indicating worse anxiety.
1 secondary outcome
Proxy reported AR experience
Time frame: Immediately following the PIV line placement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Little NIRVANA in people with Acute Pain and Procedural Anxiety, run by Nationwide Children's Hospital at 1 site in United States.
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 2 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 11 Aug 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Proxy reported pain (time frame: Immediately following the PIV line placement). 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 11 Aug 2026.