Virtual Parental Presence on Induction
- Conditions
- AnxietySurgery
- Interventions
- Other: Use of Facetime with child and parents during induction
- Registration Number
- NCT04574219
- Lead Sponsor
- Children's Hospital Medical Center, Cincinnati
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 85
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Coaching day of surgery Use of Facetime with child and parents during induction - Feasibility/Acceptability Use of Facetime with child and parents during induction This arm will be used to assess the feasibility and acceptability of using FaceTime during induction. Coaching prior to surgery Use of Facetime with child and parents during induction -
- Primary Outcome Measures
Name Time Method Virtual presence cause delays in operating room During procedure Based off operating room scheduled time vs actual start time
Assessment of parental presence with either Facetime, Skype or Teams During patients induction, assessed immediately Parent and child will use one of three applications during the induction process
Parent satisfaction with virtual presence 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 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 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 Outcome Measures
Name Time Method Child behavior induction compliance During induction, assessed immediately Child Behavior Induction Assessment is an observational scale, used to describe the compliance of a child during induction of anesthesia.
Parental Coaching - Day 1-2 hours before procedure Parents will review a standard video and handout the day of surgery. Both will outline desired behaviors to support child during induction process.
Anxiety of child During induction process, assessed immediately 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.
Patient previous induction experience After induction complete, assessed immediately Parent will complete form regarding previous experience. Will use a likert scale to compare previous experience to virtual presence experience
Parent anxiety Prior to patient moving to operating room State-Trait Anxiety Inventory assesses anxiety in adults. Responses are rated "Not at All" to "Very Much So"
Parental Coaching - Prior One week prior to surgery date 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.
Trial Locations
- Locations (2)
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Cincinnati Childrens Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States