Screen-Based Distraction Tool for Preoperative Preparation

Trial ID or NCT#

NCT03014466

Status

not recruiting iconNOT RECRUITING

Purpose

Preoperative anxiety in pediatric patients undergoing surgical procedures has been previously shown to increase the likelihood of family stressors, post- operative pain, agitation, sleep disturbances, and negative behavioral changes. The purpose of this study is to determine whether the use of a bed mounted Video Projection unit (i.e. BERT, Bedside EnterRtainment Theater) is more effective than the use of a standard of care tablet (i.e., iPad) for preventing anxiety before surgery among children undergoing anesthesia and surgery. The anticipated primary outcome will be reduction of child's anxiety in the preoperative and operating room setting and compliance with mask induction.

Official Title

Screen-Based Distraction Tool for Preoperative Preparation

Eligibility Criteria

Ages Eligible for Study: 4 Years to 10 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. Participants must:
    1. 1. be between ages of 4-10 years of age2. have comprehension of instructions in the English language3. have parental consent4. Pediatric patient must be undergoing non-emergent outpatient surgery at Lucile Packard Children's Hospital5. Children who are normally healthy (ASA I) or have a mild systemic disease (ASA II) -
Exclusion Criteria:
  1. General Exclusion Criteria are as follows:
    1. 1. Significant cognitive impairment/developmental delays per parental report or H\&P.2. Children with ASA III, 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. Children currently taking psychotropic mediations will be excluded from this study due to the affect emotion modulation4. Strong parental or patient preference for pharmacological anxiolytic5. Strong parental or patient preference for specific anxiety-reducing technique6. Children born before 32 week gestation7. Any indication that the patient may be admitted post-operatively8. Child has had previous surgery or has undergone general anesthesia9. Parent does not want to be present during transport to the OR or during induction -

Investigator(s)

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