Feasibility and Acceptability of Virtual Parental Presence on Induction of Anesthesia - Modernizing Solutions for Pediatric Anesthesia in Response to COVID-19
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 85
- Locations
- 3
- Primary Endpoint
- Virtual presence cause delays in operating room
Study Overview
Brief Summary
Our goal in this study is to investigate the feasibility and acceptability of virtual parental presence of parents on anxiety in children at induction of anesthesia at Cincinnati Children's Hospital, an institution whose use of parental presence on induction is deeply ingrained in our culture, and to determine the impact of coaching of parents either prior to arrival at the hospital vs. on the day of surgery on efficacy of virtual parental presence on induction. Our primary hypothesis is that virtual PPIA is both feasibile for the smooth induction of general anesthesia and is acceptable to parents, patients, and anesthesia providers at our isntutition. Our secondary hypothesis is that the coaching of parents prior to virtual PPIA enhances the effect of video parental presence at induction of anesthesia on children's anxiety and that coaching prior to arrival at the hospital will allow for increased ease and use of this technique.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 4 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Children from ages 4 years to 12 years old
- •ASA physical status I, II or III
- •Planned inhalational induction
- •Children presenting from home prior to surgery (not an inpatient)
- •English speaking parents and child
Exclusion Criteria
- •children with developmental delay
- •children with psychological / emotional disorders
- •children with altered mental status
- •children with language barrier
- •children who are not accompanied by someone able to consent (ie legal guardian)
- •children who are inpatient prior to surgery
- •children with expected difficult intubation/airway
- •children presenting for emergency surgery
- •family history or personal history of malignant hyperthermia / risk of MH
- •consent not obtained or withdrawl of consent
- •children with past history of violent behaviors during induction of anesthesia
- •cancellation of surgery
- •patients with a diagnosis of COVID-19 or a patient under investigation for COVID-19, including patients being treated with airborne precuations in the operating room
- •receipt of any type of medical sedative prior to induction of anesthesia, including (but not limited to) midazolam, ketamine, and/or dexmedetomidine.
Outcomes
Primary Outcomes
Virtual presence cause delays in operating room
Time Frame: During procedure
Based off operating room scheduled time vs actual start time
Assessment of parental presence with either Facetime, Skype or Teams
Time Frame: During patients induction, assessed immediately
Parent and child will use one of three applications during the induction process
Parent satisfaction with virtual presence
Time Frame: Immediately after induction
Parent will complete a satisfaction form which is 6 questions rating experience. Ratings are rated Excellent to Poor.
Operating room provider satisfaction
Time Frame: Immediately after procedure
NASA Task Load Index questionnaire. The NASA task load index (NASA TLX) is a tool for measuring and conducting a subjective mental workload (MWL) assessment. It allows you to determine the MWL of a participant while they are performing a task. It rates performance across six dimensions to determine an overall workload rating.
Operating room induction nurse satisfaction
Time Frame: Immediately after procedure
NASA Task Load Index questionnaire. The NASA task load index (NASA TLX) is a tool for measuring and conducting a subjective mental workload (MWL) assessment. It allows you to determine the MWL of a participant while they are performing a task. It rates performance across six dimensions to determine an overall workload rating.
Secondary Outcomes
- Child behavior induction compliance(During induction, assessed immediately)
- Parental Coaching - Day(1-2 hours before procedure)
- Anxiety of child(During induction process, assessed immediately)
- Patient previous induction experience(After induction complete, assessed immediately)
- Parent anxiety(Prior to patient moving to operating room)
- Parental Coaching - Prior(One week prior to surgery date)