Little NIRVANA for Procedural Anxiety

Overseen By Henry Xiang, MD, MPH, PhD, MBA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Nationwide Children's Hospital

Disqualifiers: Non-English speaking, Critical illness

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 visit

130 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Little NIRVANA for procedural anxiety?

Research shows that guided imagery, a component of Little NIRVANA, can significantly reduce anxiety and pain in surgical patients, leading to less need for pain medication. This suggests that Little NIRVANA may help manage procedural anxiety effectively. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for children aged 2-8 who are experiencing pain and anxiety during emergency hospital visits, specifically for peripheral intravenous (PIV) insertions. The study is looking to include those who can safely use augmented reality (AR) alongside a numbing cream.

Inclusion Criteria

I am between 2 and 8 years old.

I am getting a PIV line placed while in the emergency department.

Exclusion Criteria

Those for whom utilizing AR is deemed not feasible by the attending ED physician (e.g., critical illness)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 visit

Treatment

Participants receive either the Little NIRVANA AR intervention or standard care during PIV line placement

1 visit

1 visit (in-person)

Follow-up

Participants are monitored for anxiety and pain immediately following the PIV line placement

Immediately following treatment

Treatment Details

Interventions

• Little NIRVANA

Trial Overview The Little NIRVANA system, an augmented reality tool, is being tested to see if it helps reduce pain and anxiety in kids during PIV placement in the ER. It's compared with just using numbing cream to find out if it makes these procedures easier without causing delays or extra attempts.

Participant Groups

Group I: Intervention Group Experimental Treatment 1 Intervention

Participants will receive a topical anesthetic cream and will use Little NIRVANA AR digital solution during PIV line placement

Group II: Control Active Control 1 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 Is Running the Clinical Trial?

Nationwide Children's Hospital

Lead Sponsor

Trials

354

Recruited

5,228,000+

KU Leuven

Collaborator

Trials

587

Recruited

200,340,000+

Health Resources and Services Administration (HRSA)

Collaborator

Trials

88

Recruited

152,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Guided Imagery for Postoperative Symptoms, Sleep Quality, Anxiety, and Satisfaction Regarding Nursing Care: A Randomized Controlled Study. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Patient-reported perioperative anaesthesia-related anxiety is associated with impaired patient satisfaction: a secondary analysis from a prospective observational study in Switzerland. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Guided imagery as a coping strategy for perioperative patients. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

[Evaluation of psychological stress before general anesthesia]. [2006]

5. England pubmed.ncbi.nlm.nih.gov

Anxiety management in minimal stay surgery. [2022]