N/A
N=71
Perioperative Virtual Reality for Pediatric Anesthesia
Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT03583450 ↗Enrolled (actual)
71
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Perioperative Pediatric Anxiety (Change From Baseline) — 0.0; 5.0 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Perioperative virtual reality headset with mobile app (Device)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Perioperative Pediatric Anxiety (Change From Baseline) |
0.0; 13.3 | — |
| PRIMARY Perioperative Pediatric Anxiety (Change From Baseline) |
0.0; 13.3 | — |
| SECONDARY Perioperative Parental Anxiety (Change From Baseline) |
0; 0 | — |
| SECONDARY Induction Compliance Checklist |
0; 0 | — |
| SECONDARY Parental Satisfaction |
83; 80 | — |
Summary
The goal of this study is to evaluate the use of immersive audiovisual distraction and virtual reality to reduce perioperative anxiety in pediatric patients undergoing surgery at UCSF Benioff Children's Hospital. The study plans to employ virtual reality headsets during induction of anesthesia in pediatric patients for elective surgery in a randomized clinical trial.
Eligibility Criteria
Inclusion Criteria
- Patients aged 5-12 years
- Patients present in preoperative area for induction of general anesthesia for an elective surgery or procedure
Exclusion Criteria
- Patients with injuries to the head/face that would prohibit wearing of headsets
- Patients with loss of consciousness, altered mental status, life-threatening injuries/illness or multi-trauma
- Patients with open skin, lice, scabies, or other infectious skin conditions on the head/face
- Patients with a history of or current symptoms of vertigo
- Patients who are blind
- Patients with significant developmental or cognitive delays who may not be able to engage with or tolerate the virtual reality environment, as determined by their parent/caregiver
- Patients on whom the VR headset does not fit appropriately
- Non-English speaking patients (due to limited availability of non-English study documents and consents)
Data sourced from ClinicalTrials.gov (NCT03583450). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.