Evaluation of Technology-Based Stress Reduction Techniques Prior to Vascular Access

Trial ID or NCT#

NCT03220828

Status

not recruiting iconNOT RECRUITING

Purpose

Preprocedural, preoperative, and prevascular access anxiety in pediatric patients has been previously shown to increase the likelihood of family stressors, postoperative pain, agitation, sleep disturbances, and negative behavioral changes. The purpose of this study is to determine if a non-invasive distracting devices (Virtual Reality headset) is more effective than the standard of care (i.e., no technology based distraction) for preventing anxiety before vascular access among hospitalized children undergoing vascular access prior to anesthesia, procedures, surgery, blood draws, port access, or peripheral IV placement. The anticipated primary outcome will be reduction of child's anxiety during and after vascular access.

Official Title

Evaluation of Technology-Based Stress Reduction Techniques Prior to Vascular Access

Eligibility Criteria

Ages Eligible for Study: 7 Years to 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
  1. 1. be between ages of 7-18 years of age 2. have comprehension of instructions in the English language 3. have parental consent 4. Pediatric patient must be undergoing non-emergent vascular access at Lucile Packard Children's Hospital in one of the 6 previously defined care areas (please see study design in Section 16). 5. Children who are normally healthy (ASA I) or have a mild systemic disease (ASA II,III)-
Exclusion Criteria:
  1. 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 >24hours or without the operation) 3. H/o severe motion sickness, nausea, seizures

Investigator(s)

Samuel Rodriguez, MD
Anesthesiologist
Clinical Professor, Anesthesiology, Perioperative and Pain Medicine
Thomas Caruso
Anesthesiologist
Clinical Professor, Anesthesiology, Perioperative and Pain Medicine

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Contact

Sam Rodriguez, MD
650-723-5728