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VR Usage in Non-Invasive Surgical Sub-Specialty Procedures
Not Recruiting
Trial ID: NCT03464955
Purpose
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
Eligibility
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
Intervention(s):
behavioral: Technology Based Distractions
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Sam Rodriguez, MD
650-723-5728