VR to Reduce Pain/Anxiety During Painful Procedures

  • STATUS
    Recruiting
  • End date
    Dec 6, 2025
  • participants needed
    700
  • sponsor
    Children's Hospital Los Angeles
Updated on 19 April 2022
anxiety
Accepts healthy volunteers

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 painful procedures in Phlebotomy, Radiology, Infusion, Orthopedics, Gastroenterology, and Immunology, amongst others, at CHLA, as measured by self- and proxy-report. Examples of the painful procedures include IV sticks, cast removals, allergy testing, and anorectal manometries.

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 240 children ages 7-21 and their caregivers who arrive at the hospital for an outpatient painful medical procedure. 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 medical procedure 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.

Details
Condition Phlebotomy, Orthopedics, Radiology, Pain, Anxiety, Virtual Reality, Allergy, Gastroenterology
Treatment Samsung Gear VR, Merge VR, Oculus Go
Clinical Study IdentifierNCT04268901
SponsorChildren's Hospital Los Angeles
Last Modified on19 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Inclusion Criteria for Children
Children who are 7-21 years old
Children who are English speaking (caregivers may be Spanish English speaking or Spanish speaking)
Children who are undergoing a painful medical procedure (e.g., venipuncture, IV placement, PICC lines, wound care, cast removal, botox injections) are eligible to participate in this project
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
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