Virtual Parental Presence on Induction (VPPIA)

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Surgery; Anxiety

Treatments: Other: Use of Facetime with child and parents during induction

Study type: Interventional

Funder types: Other

Identifiers

NCT04574219

2020-0371

Details and patient eligibility

About

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.

Enrollment: 85 patients

Sex: All

Ages: 4 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

85 participants in 3 patient groups

Feasibility/Acceptability

Other group

Description:

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

Treatment:

Other: Use of Facetime with child and parents during induction

Coaching prior to surgery

Other group

Treatment:

Other: Use of Facetime with child and parents during induction

Coaching day of surgery

Other group

Treatment:

Other: Use of Facetime with child and parents during induction