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Completed

NCT Number: NCT04574219

Virtual Parental Presence on Induction

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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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders Surgery

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Sick Children, Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Use of Facetime with child and parents during induction

Other

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

Primary outcomes

  1. Virtual presence cause delays in operating room

    Time frame: During procedure

    Based off operating room scheduled time vs actual start time

  2. Parent satisfaction with virtual presence

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: During patients induction, assessed immediately

    Parent and child will use one of three applications during the induction process

Secondary outcomes

  1. Anxiety of child

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • The Hospital for Sick Children

Registry information

Official study title

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

Acronym: VPPIA

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 5, 2020
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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