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Virtual Parental Presence on Induction

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04574219
Acronym
VPPIA
Enrollment
85
Registered
2020-10-05
Start date
2020-11-03
Completion date
2022-12-19
Last updated
2024-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Surgery

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.

Interventions

OTHERUse 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

Sponsors

The Hospital for Sick Children
CollaboratorOTHER
Children's Hospital Medical Center, Cincinnati
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Virtual presence cause delays in operating roomDuring procedureBased off operating room scheduled time vs actual start time
Parent satisfaction with virtual presenceImmediately after inductionParent will complete a satisfaction form which is 6 questions rating experience. Ratings are rated Excellent to Poor.
Operating room provider satisfactionImmediately after procedureNASA 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.
Operating room induction nurse satisfactionImmediately after procedureNASA 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.
Assessment of parental presence with either Facetime, Skype or TeamsDuring patients induction, assessed immediatelyParent and child will use one of three applications during the induction process

Secondary

MeasureTime frameDescription
Anxiety of childPrior to inductionUse 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.
Parental Coaching - Day1-2 hours before procedureParents will review a standard video and handout the day of surgery. Both will outline desired behaviors to support child during induction process.
Child behavior induction complianceDuring induction, assessed immediatelyChild Behavior Induction Assessment is an observational scale, used to describe the compliance of a child during induction of anesthesia.
Parent anxietyPrior to patient moving to operating roomState-Trait Anxiety Inventory assesses anxiety in adults. Responses are rated Not at All to Very Much So
Patient previous induction experienceAfter induction complete, assessed immediatelyParent will complete form regarding previous experience. Will use a likert scale to compare previous experience to virtual presence experience
Parental Coaching - PriorOne week prior to surgery dateParents will review a standard video and handout for a week prior to surgery. Both will outline desired behaviors to support child during induction process.

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026