VR to Reduce Pain/Anxiety During IV Starts

NCT04942561 | Completed

• 1 other identifier: CHLA-15-00549_A
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to test the effectiveness of virtual reality (VR) as a non-pharmaceutical intervention to reduce pain and anxiety in children undergoing peripheral intravenous catheter (PIVC) access in the Department of Radiology and Imaging or the outpatient Infusion Center at CHLA, as measured by self- and proxy-report.

Conditions

Radiology

Keywords

IV Stick; Pain; Anxiety; Virtual Reality; Radiology

Outcome Measures

Primary Outcomes (2)

• Visual Analogue Scale (VAS)

  The VAS anticipatory anxiety measure is a vertical VAS, anchored with 0 at the bottom indicating the least amount and 10 at the top indicating the greatest amount, in response to the instruction to rate "how nervous, afraid, or worried" they were about the upcoming task. The scale also has color cues, graded from yellow at the bottom to dark red at the top, as well as a neutral face at the bottom and a face showing a negative expression at the top. Prior research used the VAS to rate anticipatory anxiety and pain in children

  Approximately 5 minutes to one hour before procedure

• Faces Pain Scale-Revised (FPS-R)

  Revised is an updated version of the Wong-Baker Faces Pain Rating Scale depicting no pain as a neutral expression as compared with the smiling face of the original measure. The child is asked to point to the face cartoon that depicts how they are currently feeling because of their pain. Face measures are thought to measure pain intensity, and the Wong-Baker Faces measure has demonstrated good reliability and validity.

  Approximately 5 minutes to one hour before procedure

Secondary Outcomes (2)

• Gold & Rizzo Immersion/Presence (GRIP) Inventory

  Approximately 5 minutes to one hour before procedure

• Childhood Anxiety Sensitivity Index (CASI)

  Approximately 5 minutes to one hour before procedure

Study Arms (2)

Standard of Care (No VR) Randomization

NO INTERVENTION

In the standard of care treatment condition, participants will receive the standard CHLA treatment protocol for PIVC placement (i.e., a topical numbing spray and Buzzy® Bee, a vibrating device placed near the PIVC site for pain distraction).

VR Randomization

EXPERIMENTAL

Children in the VR condition will undergo the invasive procedure while distracted by interaction with an immersive virtual environment (VE) presented via a head mounted display (HMD). The intervention group will receive standard CHLA treatment with VR distraction. Patients began gameplay \<5 minutes before their PIVC placement and concluded after successful vascular access.

Device: Samsung Gear VR; Device: Merge VR

Interventions

Samsung Gear VR DEVICE

Participants 13 -21 years old can use the Samsung Gear VR. The VE is mobile based (Samsung with the Gear VR) and has active matrix LCDs with high pixel resolution, creating a bright, vibrant color and a quality image. Participants will engage with BearBlast (appliedVR™), a multi-sensory VR game in which users travel on a pre-set path through a colorful, highly-interactive 3-D environment filled with animated landscapes, buildings, and clouds, during which the user's gaze controls the direction of a firing cannon to knock down teddy bears. The VR game is equipped with a head-tracking system, enabling the player to look around the VE. Therefore, the child will be receiving distraction via 3-D visual and auditory sensory, thus supplying a multi-sensory immersive experience. While wearing these glasses, the children only can see the HMD screen so that the immersion and presence will be increased. The VR glasses will be sanitized before every use to minimize chance of infection.

VR Randomization

Merge VR DEVICE

Participants 10-21 years can use the Merge. The VE to be used in this study is mobile based (Pixel with the Merge) and has active matrix LCDs with high pixel resolution, creating a bright, vibrant color and a quality image. Participants will engage with BearBlast (appliedVR™), a multi-sensory VR game in which users travel on a pre-set path through a colorful, highly-interactive 3-D environment filled with animated landscapes, buildings, and clouds, during which the user's gaze controls the direction of a firing cannon to knock down teddy bears. The VR game is equipped with a head-tracking system, enabling the player to look around the VE. Therefore, the child will be receiving distraction via 3-D visual and auditory sensory, thus supplying a multi-sensory immersive experience. While wearing these glasses, the children only can see the HMD screen so that the immersion and presence will be increased. The VR glasses will be sanitized before every use to minimize chance of infection.

VR Randomization

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children who are 10-21 years old
• Children who are English speaking (caregivers may be Spanish English speaking or Spanish speaking)
• Children who are undergoing PIVC access in the Department of Radiology and Imaging or the outpatient Infusion Center.
• Only children who are in the normal range of development will be recruited for this study. This will be assessed by report from the parents. The rationale for excluding patients with developmental delay is that due to their cognitive impairments, such children react to the stressors of surgery differently than do children without such developmental delay. It is unclear how such children would use the interventions included in this study, and it is likely that their responses on baseline and outcome measures will differ from children of normal developmental parameters.
• Healthcare providers must be 18 years old or older
• Healthcare providers must be Children's Hospital Los Angeles staff
• Healthcare providers may participate if they have witnessed and/or administered the medical procedure

You may not qualify if:

• Children who are currently taking pain medication or anxiolytic medication will be excluded from this study.
• Children with a psychiatric disorder, organic brain syndrome, mental retardation, or other known cognitive/neurological disorders
• Children with visual, auditory, or tactile deficits that would interfere with the ability to complete the experimental tasks
• Children with a history of seizure disorder.
• Children currently sick with flu-like symptoms or experiencing a headache or earache.
• Children with known or suspected motion sickness

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead
• AppliedVR Inc.: collaborator

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Related Publications (45)

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MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Jeffrey I Gold, PhD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: June 28, 2021
• Study Start: April 12, 2017
• Primary Completion: July 24, 2019
• Study Completion: July 24, 2019
• Last Updated: July 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)