Effect of Immersive Virtual Reality on Pain and Anxiety in Pediatric Peripheral Intravenous Catheter Access: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 107
- Locations
- 1
- Primary Endpoint
- Visual Analogue Scale (VAS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 10 Years to 21 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •for Children:
- •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.
- •Inclusion criteria for healthcare providers:
- •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
Exclusion Criteria
- •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
Arms & Interventions
Standard of Care (No VR) Randomization
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
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.
Intervention: Samsung Gear VR (Device)
VR Randomization
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.
Intervention: Merge VR (Device)
Outcomes
Primary Outcomes
Visual Analogue Scale (VAS)
Time Frame: Approximately 5 minutes to one hour before procedure
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
Faces Pain Scale-Revised (FPS-R)
Time Frame: Approximately 5 minutes to one hour before procedure
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.
Secondary Outcomes
- 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)
Investigators
Jeffrey I Gold, PhD
Principal Investigator
Children's Hospital Los Angeles