Clinical trial NCT04574219: Virtual Parental Presence on Induction
Official title: Feasibility and Acceptability of Virtual Parental Presence on Induction of Anesthesia - Modernizing Solutions for Pediatric Anesthesia in Response to COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Surgery
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: The Hospital for Sick Children
First posted: 2020-10-05
Enrollment: 85
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Virtual presence cause delays in operating room
timeFrame: During procedure
measure: Parent satisfaction with virtual presence
timeFrame: Immediately after induction
measure: Operating room provider satisfaction
timeFrame: Immediately after procedure
measure: Operating room provider satisfaction
timeFrame: Immediately after procedure
measure: Operating room induction nurse satisfaction
timeFrame: Immediately after procedure
measure: Operating room induction nurse satisfaction
timeFrame: Immediately after procedure
measure: Assessment of parental presence with either Facetime, Skype or Teams
timeFrame: During patients induction, assessed immediately
Secondary outcomes:
measure: Anxiety of child
timeFrame: Prior to induction
measure: Anxiety of child
timeFrame: During induction process, assessed immediately
measure: Child behavior induction compliance
timeFrame: During induction, assessed immediately
measure: Parent anxiety
timeFrame: Prior to patient moving to operating room
measure: Patient previous induction experience
timeFrame: After induction complete, assessed immediately
measure: Parental Coaching - Prior
timeFrame: One week prior to surgery date
measure: Parental Coaching - Day
timeFrame: 1-2 hours before procedure
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Childrens Hospital Medical Center
state: Ohio
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
affiliation: Cincinnati Childrens Hospital Medical Center
name: Kenneth Goldschneider, MD
role: PRINCIPAL_INVESTIGATOR
References: