Virtual Parental Presence on Induction

NCT04574219 | Completed

• 1 other identifier: 2020-0371
• Study Type: interventional
• Target: 85
• Locations: 2 countries
• Sites: 2

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.

Conditions

Anxiety; Surgery

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (7)

• Anxiety of child

  Prior to induction

• Anxiety of child

  During induction process, assessed immediately

• Child behavior induction compliance

  During induction, assessed immediately

• Parent anxiety

  Prior to patient moving to operating room

• Patient previous induction experience

  After induction complete, assessed immediately

Study Arms (3)

Feasibility/Acceptability

OTHER

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

Coaching prior to surgery

OTHER

Other: Use of Facetime with child and parents during induction

Coaching day of surgery

OTHER

Other: Use of Facetime with child and parents during induction

Interventions

Use of Facetime with child and parents during induction OTHER

Families will be able to use Facetime with their child when the child is taken to the operating room

Coaching day of surgery; Coaching prior to surgery; Feasibility/Acceptability

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• The Hospital for Sick Children: collaborator

Study Sites (2)

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Hospital for Sick Children

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Kenneth Goldschneider, MD

  Cincinnati Childrens Hospital Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: October 5, 2020
• Study Start: November 3, 2020
• Primary Completion: December 19, 2022
• Study Completion: December 19, 2022
• Last Updated: August 20, 2024

Record last verified: 2024-08

Locations

US (1); CA (1)