Virtual Parental Presence on Induction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-03

Study Completion Date

2022-12-19

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.

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Detailed Description

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Conditions

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Anxiety Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Feasibility/Acceptability

This arm will be used to assess the feasibility and acceptability of using FaceTime during induction.

Group Type OTHER

Use of Facetime with child and parents during induction

Intervention Type OTHER

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

Coaching prior to surgery

Group Type OTHER

Use of Facetime with child and parents during induction

Intervention Type OTHER

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

Coaching day of surgery

Group Type OTHER

Use of Facetime with child and parents during induction

Intervention Type OTHER

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

Interventions

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Use 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

Intervention Type OTHER

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.

Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No