Clinical trial NCT04942561: VR to Reduce Pain/Anxiety During IV Starts
Official title: Effect of Immersive Virtual Reality on Pain and Anxiety in Pediatric Peripheral Intravenous Catheter Access: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiology
Keywords: IV Stick
Pain
Anxiety
Virtual Reality
Radiology
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
Collaborators: name: AppliedVR Inc.
First posted: 2021-06-28
Enrollment: 107
Sex: ALL
Minimum age (years): 10
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Distraction is a form of non pharmacological intervention for reducing pain and anxiety in children during painful medical procedures (e.g., venipuncture, IV placement). Recent technological developments in the area of virtual reality (VR) provide new and potentially more effective ways of distracting children from the pain and anxiety associated with medical procedures. While initial studies of VR pain distraction are promising, few have studied the effectiveness of the technology in children, using a multi-method approach. The current study aims to recruit 115 children ages 10-21 years and their caregivers who arrive at the hospital for peripheral intravenous catheter (PIVC) access in the Department of Radiology and Imaging or the outpatient Infusion Center. Children and their parents will be randomly assigned to one of two treatment conditions: 1) existing hospital standard of care or 2) standard of care plus distraction via VR. Children and caregivers will be asked to complete measures assessing pain and anxiety both before and after the procedure. In addition, objective measures of child pain and distress during the PIVC access will be taken using coding of behavioral/verbal expressions. Univariate Analysis of Variance (ANOVA) will be used to compare differences in primary and secondary outcome variables in VR + standard of care to standard of care only conditions when pre and post-operative measures are available. Univariate ANOVA will be used to compare conditions on post-operative variables.

Eligibility criteria: Inclusion Criteria for Children:

1. Children who are 10-21 years old
2. Children who are English speaking (caregivers may be Spanish English speaking or Spanish speaking)
3. Children who are undergoing PIVC access in the Department of Radiology and Imaging or the outpatient Infusion Center.
4. 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.

Inclusion criteria for healthcare providers:

1. Healthcare providers must be 18 years old or older
2. Healthcare providers must be Children's Hospital Los Angeles staff
3. Healthcare providers may participate if they have witnessed and/or administered the medical procedure

Exclusion Criteria:

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

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: Approximately 5 minutes to one hour before procedure
measure: Faces Pain Scale-Revised (FPS-R)
timeFrame: Approximately 5 minutes to one hour before procedure
Secondary outcomes:
measure: Gold & Rizzo Immersion/Presence (GRIP) Inventory
timeFrame: Approximately 5 minutes to one hour before procedure
measure: Childhood Anxiety Sensitivity Index (CASI)
timeFrame: Approximately 5 minutes to one hour before procedure
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Jeffrey I Gold, PhD
role: PRINCIPAL_INVESTIGATOR
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