Virtual Parental Presence on Induction (VPPIA)

Feasibility and Acceptability of Virtual Parental Presence on Induction of Anesthesia - Modernizing Solutions for Pediatric Anesthesia in Response to COVID-19

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 Overview

• Status: Completed
• Conditions: Anxiety; Surgery
• Intervention / Treatment: Other: Use of Facetime with child and parents during induction

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kennreth Goldschneider, MD; Phone Number: 513-636-4408; Email: kenneth.goldschneider@cchmc.org
• Study Contact Backup: Name: Kristie Geisler, BS, CCRP; Phone Number: 513-636-3282; Email: kristie.geisler@cchmc.org

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • Hospital For Sick Children
• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Childrens Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Feasibility/Acceptability; This arm will be used to assess the feasibility and acceptability of using FaceTime during induction.	Other: Use of Facetime with child and parents during induction; Families will be able to use Facetime with their child when the child is taken to the operating room
Other: Coaching prior to surgery	Other: Use of Facetime with child and parents during induction; Families will be able to use Facetime with their child when the child is taken to the operating room
Other: Coaching day of surgery	Other: Use of Facetime with child and parents during induction; Families will be able to use Facetime with their child when the child is taken to the operating room

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Virtual presence cause delays in operating room	Based off operating room scheduled time vs actual start time	During procedure
Parent satisfaction with virtual presence	Parent will complete a satisfaction form which is 6 questions rating experience. Ratings are rated Excellent to Poor.	Immediately after induction
Operating room provider satisfaction	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.	Immediately after procedure
Operating room provider satisfaction	System Usability Scale. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree.	Immediately after procedure
Operating room induction nurse satisfaction	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.	Immediately after procedure
Operating room induction nurse satisfaction	System Usability Scale. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree.	Immediately after procedure
Assessment of parental presence with either Facetime, Skype or Teams	Parent and child will use one of three applications during the induction process	During patients induction, assessed immediately

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety of child	Use of modified Yale Preoperative Anxiety Scale (mYPAS) measures anxiety at anesthesia induction. It looks at activity, facial expression, alertness and arousal, vocalization and interaction with adults.	Prior to induction
Anxiety of child	Use of modified Yale Preoperative Anxiety Scale (mYPAS) measures anxiety at anesthesia induction. It looks at activity, facial expression, alertness and arousal, vocalization and interaction with adults.	During induction process, assessed immediately
Child behavior induction compliance	Child Behavior Induction Assessment is an observational scale, used to describe the compliance of a child during induction of anesthesia.	During induction, assessed immediately
Parent anxiety	State-Trait Anxiety Inventory assesses anxiety in adults. Responses are rated "Not at All" to "Very Much So"	Prior to patient moving to operating room
Patient previous induction experience	Parent will complete form regarding previous experience. Will use a likert scale to compare previous experience to virtual presence experience	After induction complete, assessed immediately
Parental Coaching - Prior	Parents will review a standard video and handout for a week prior to surgery. Both will outline desired behaviors to support child during induction process.	One week prior to surgery date
Parental Coaching - Day	Parents will review a standard video and handout the day of surgery. Both will outline desired behaviors to support child during induction process.	1-2 hours before procedure

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: The Hospital for Sick Children
• Investigators: Principal Investigator: Kenneth Goldschneider, MD, Cincinnati Childrens Hospital Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2020
• Primary Completion (Actual): December 19, 2022
• Study Completion (Actual): December 19, 2022

Study Registration Dates

• First Submitted: September 24, 2020
• First Submitted That Met QC Criteria: September 29, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Estimated): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2020-0371

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No