Pain Elimination and Anxiety Control Through Experiential Virtual Reality

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.

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Key information

Conditions

Procedural Pain Neurologic Manifestations Pain Pain, Procedural Pathological Conditions, Signs and Symptoms Procedural Anxiety Signs and Symptoms

Age range

8 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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).

Treatment and study plan

Active Virtual Reality

Device

Active virtual reality group will play a game through a virtual environment.

Passive Virtual Reality

Device

Passive virtual reality group will watch a movie through a virtual environment.

Primary outcomes

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).

Secondary outcomes

Mean Change from Baseline in Anxiety Scores on Visual Analog Scale after IV Placement

Time frame: 5 minutes before, immediately after procedure

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).
Mean Change from Baseline in Heart Rate after IV Placement

Time frame: 5 minutes before, during, and immediately after procedure

Heart Rate will be measured 5 minutes before, during, and immediately after procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Matan Paret, MD

CONTACT

[email protected]

3233764793

Sponsors and collaborators

Lead sponsor

Children's Hospital Los Angeles

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Jul 17, 2024
Registry last updated: Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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