VR Usage in Non-Invasive Surgical Sub-Specialty Procedures

Not Recruiting

Trial ID: NCT03464955


Preprocedural, preoperative, and prevascular access anxiety in pediatric patients has been previously shown to increase the likelihood of family stressors, agitation, sleep disturbances, and negative behavioral changes. The purpose of this study is to determine if a non-invasive distracting device (Virtual Reality (VR) headset, Augmented Reality (AR) headset, or bed mounted Video Projection unit (i.e. BERT, Bedside EnterRtainment Theater)) is more effective than the standard of care (i.e., no technology based distraction) for preventing anxiety before non-invasive surgical sub-specialty procedures among children during out-patient clinic visits. Examples of the most common procedures include, but are not limited to gastrostomy tube exchanges, suture removals, dressing changes, foley insertions, EEG set up, chest tube removals, cast removals, pin removals and other similar procedures. (The investigators refer to these procedures under an umbrella term of non-invasive surgical subspecialty procedures). The anticipated primary outcome will be reduction of child's anxiety during and after procedures.

Official Title

Virtual Reality Usage in Non-Invasive Surgical Sub-Specialty Procedures

Stanford Investigator(s)

Samuel Rodriguez, MD

Clinical Professor, Anesthesiology, Perioperative and Pain Medicine

Thomas Caruso

Clinical Professor, Anesthesiology, Perioperative and Pain Medicine


Inclusion Criteria:

   1. Be between ages of 2-18 years of age

   2. Have comprehension of instructions in the English language

   3. Have parental consent

   4. Pediatric patients must be undergoing non-invasive surgical subspecialty procedures at
   an Lucile Packard Children's Hospital (LPCH) out-patient clinic

   5. Children who are normally healthy (ASA I) or have a mild systemic disease (ASA II,III)

Exclusion Criteria:

   1. Significant cognitive impairment/developmental delays per parental report or H&P.

   2. Children with ASA IV (severe systemic disease that is a constant threat to life) or
   ASA V (unstable patients not expected to survive >24 hours or without the operation)

   3. Children currently taking psychotropic mediations will be excluded from this study due
   to the affect emotion modulation

   4. Strong parental or patient preference for pharmacological anxiolytic

   5. Strong parental or patient preference for specific anxiety-reducing technique


behavioral: Technology Based Distractions

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sam Rodriguez, MD