VPPIA: Virtual Parental Presence on Induction

Sponsor
Children's Hospital Medical Center, Cincinnati (Other)
Overall Status
Recruiting
CT.gov ID
NCT04574219
Collaborator
The Hospital for Sick Children (Other)
184
2
3
24.9
92
3.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Use of Facetime with child and parents during induction
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
184 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Feasibility and Acceptability of Virtual Parental Presence on Induction of Anesthesia - Modernizing Solutions for Pediatric Anesthesia in Response to COVID-19
Actual Study Start Date :
Nov 3, 2020
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Feasibility/Acceptability

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

Other: Coaching prior to surgery

Other: 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

Other: Coaching day of surgery

Other: 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

Outcome Measures

Primary Outcome Measures

  1. Virtual presence cause delays in operating room [During procedure]

    Based off operating room scheduled time vs actual start time

  2. 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.

  3. Operating room provider satisfaction [Immediately after procedure]

    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.

  4. 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.

  5. Operating room induction nurse satisfaction [Immediately after procedure]

    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.

  6. 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.

  7. 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

Secondary Outcome Measures

  1. Anxiety of child [Prior to induction]

    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.

  2. 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.

  3. 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.

  4. 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"

  5. 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

  6. 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.

  7. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 12 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cincinnati Childrens Hospital Medical Center Cincinnati Ohio United States 45229
2 Hospital for Sick Children Toronto Ontario Canada

Sponsors and Collaborators

  • Children's Hospital Medical Center, Cincinnati
  • The Hospital for Sick Children

Investigators

  • Principal Investigator: Kenneth Goldschneider, MD, Cincinnati Childrens Hospital Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT04574219
Other Study ID Numbers:
  • 2020-0371
First Posted:
Oct 5, 2020
Last Update Posted:
Jul 19, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 19, 2022