Virtual Parental Presence on Induction

Study Overview
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Brief Summary
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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.

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

Conditions
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Anxiety, Surgery

Intervention / Treatment
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* Other: Use of Facetime with child and parents during induction


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Feasibility/Acceptability<br>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<br>* Families will be able to use Facetime with their child when the child is taken to the operating room<br>|
| Other: Coaching prior to surgery<br> | Other: Use of Facetime with child and parents during induction<br>* Families will be able to use Facetime with their child when the child is taken to the operating room<br>|
| Other: Coaching day of surgery<br> | Other: Use of Facetime with child and parents during induction<br>* Families will be able to use Facetime with their child when the child is taken to the operating room<br>|

What is the study measuring?
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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 |