Using virtual reality to ease pain and anxiety in children during medical procedures
Effectiveness of Virtual Reality to Reduce Pain/Anxiety During Routine Painful Procedures
This study tests if using virtual reality can help reduce pain and anxiety in children aged 7-21 during painful medical procedures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 700 (estimated) |
| Ages | 7 Years to 21 Years |
| Sex | All |
| Sponsor | Children's Hospital Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT04268901 on ClinicalTrials.gov |
What this trial studies
This study tests the effectiveness of virtual reality (VR) as a non-pharmaceutical method to reduce pain and anxiety in children aged 7-21 undergoing painful medical procedures, such as IV sticks and cast removals. Participants will be randomly assigned to receive either standard care or standard care plus VR distraction. The study will involve 240 children and their caregivers, who will complete assessments of pain and anxiety before and after the procedures. Objective measures of pain and distress will also be recorded during the procedures, and data will be analyzed using ANOVA to compare outcomes between the two groups.
Who should consider this trial
Good fit: Ideal candidates are children aged 7-21 who are undergoing painful medical procedures and are developmentally normal.
Not a fit: Patients with developmental delays may not benefit from this study due to differing responses to stressors and interventions.
Why it matters
Potential benefit: If successful, this approach could significantly reduce pain and anxiety in children during medical procedures, improving their overall experience and outcomes.
How similar studies have performed: Initial studies on VR for pain distraction have shown promise, but this study specifically focuses on children, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Inclusion Criteria for Children: 1. Children who are 7-21 years old 2. Children who are English speaking (caregivers may be Spanish English speaking or Spanish speaking) 3. 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. 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
Where this trial is running
Los Angeles, California
- Children's Hospital Los Angeles — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Jeffrey I Gold, PhD — Children's Hospital Los Angeles
- Study coordinator: Nhat Ngo, BS, BA
- Email: nngo@chla.usc.edu
- Phone: 3233616244
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.