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Clinical Trials/NCT04574219
NCT04574219
Completed
Not Applicable

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

Children's Hospital Medical Center, Cincinnati2 sites in 2 countries85 target enrollmentNovember 3, 2020
ConditionsAnxietySurgery

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety
Sponsor
Children's Hospital Medical Center, Cincinnati
Enrollment
85
Locations
2
Primary Endpoint
Virtual presence cause delays in operating room
Status
Completed
Last Updated
last year

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.

Registry
clinicaltrials.gov
Start Date
November 3, 2020
End Date
December 19, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

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 induction nurse satisfaction

Time Frame: Immediately after procedure

System Usability Scale. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree.

Operating room provider satisfaction

Time Frame: Immediately after procedure

System Usability Scale. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree.

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)

Study Sites (2)

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