AnxietyVPPIANCT04574219
Virtual Parental Presence on Induction
A study testing Use of Facetime with child and parents during induction in people with Anxiety and Surgery, run by Children's Hospital Medical Center, Cincinnati at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 12 years
- What is being tested?
- Use of Facetime with child and parents during induction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 3 Nov 2020to 19 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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 locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Feasibility and Acceptability of Virtual Parental Presence on Induction of Anesthesia - Modernizing Solutions for Pediatric Anesthesia in Response to COVID-19
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.
- Being tested
- Use of Facetime with child and parents during induction
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Facetime with child and parents during inductionOther
Families will be able to use Facetime with their child when the child is taken to the operating room
| Study group | Role | What they receive |
|---|---|---|
| Feasibility/Acceptability | Other | This arm will be used to assess the feasibility and acceptability of using FaceTime during induction. Receives: Other: Use of Facetime with child and parents during induction |
| Coaching prior to surgery | Other | Not described Receives: Other: Use of Facetime with child and parents during induction |
| Coaching day of surgery | Other | Not described Receives: Other: Use of Facetime with child and parents during induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virtual presence cause delays in operating room
Based off operating room scheduled time vs actual start time
Measured: During procedure
Parent satisfaction with virtual presence
Parent will complete a satisfaction form which is 6 questions rating experience. Ratings are rated Excellent to Poor.
Measured: Immediately after induction
Operating room provider satisfaction
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.
Measured: Immediately after procedure
Operating room provider satisfaction
System Usability Scale. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree.
Measured: Immediately after procedure
Operating room induction nurse satisfaction
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.
Measured: Immediately after procedure
Operating room induction nurse satisfaction
System Usability Scale. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree.
Measured: Immediately after procedure
Assessment of parental presence with either Facetime, Skype or Teams
Parent and child will use one of three applications during the induction process
Measured: During patients induction, assessed immediately
Secondary outcomes (7)
Anxiety of child
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.
Measured: Prior to induction
Anxiety of child
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.
Measured: During induction process, assessed immediately
Child behavior induction compliance
Child Behavior Induction Assessment is an observational scale, used to describe the compliance of a child during induction of anesthesia.
Measured: During induction, assessed immediately
Parent anxiety
State-Trait Anxiety Inventory assesses anxiety in adults. Responses are rated "Not at All" to "Very Much So"
Measured: Prior to patient moving to operating room
Patient previous induction experience
Parent will complete form regarding previous experience. Will use a likert scale to compare previous experience to virtual presence experience
Measured: After induction complete, assessed immediately
Parental Coaching - Prior
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.
Measured: One week prior to surgery date
Parental Coaching - Day
Parents will review a standard video and handout the day of surgery. Both will outline desired behaviors to support child during induction process.
Measured: 1-2 hours before procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start3 Nov 2020
- Primary completion19 Dec 2022
- Study completion19 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital for Sick Children
- Responsible party
- Sponsor
- Investigators
- Kenneth Goldschneider, MD, Principal investigator, Cincinnati Childrens Hospital Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574219
- Sponsor's protocol ID
- 2020-0371
- Acronym
- VPPIA
- Status last verified
- Aug 2024
- First submitted
- 24 Sep 2020
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Virtual Parental Presence on Induction of Anesthesia - Modernizing Solutions for Pediatric Anesthesia in Response to COVID-19
- ClinicalTrials.gov ID
- NCT04574219
- Acronym / sponsor ID
- VPPIA / 2020-0371
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- The Hospital for Sick Children
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 19 Dec 2022 (actual)
- Study completion
- 19 Dec 2022 (actual)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Feasibility/Acceptability | Other | Other: Use of Facetime with child and parents during inductionThis arm will be used to assess the feasibility and acceptability of using FaceTime during induction. |
| Coaching prior to surgery | Other | Other: Use of Facetime with child and parents during induction |
| Coaching day of surgery | Other | Other: Use of Facetime with child and parents during induction |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of Facetime with child and parents during inductionFamilies will be able to use Facetime with their child when the child is taken to the operating room | Other | Coaching day of surgery, Coaching prior to surgery, Feasibility/Acceptability |
Primary outcome
Virtual presence cause delays in operating room
Time frame: During procedure
Based off operating room scheduled time vs actual start time
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.
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.
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.
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.
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.
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
7 secondary outcomes
Anxiety of child
Time frame: Prior to induction
Anxiety of child
Time frame: During induction process, assessed immediately
Child behavior induction compliance
Time frame: During induction, assessed immediately
Parent anxiety
Time frame: Prior to patient moving to operating room
Patient previous induction experience
Time frame: After induction complete, assessed immediately
Parental Coaching - Prior
Time frame: One week prior to surgery date
Parental Coaching - Day
Time frame: 1-2 hours before procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Goldschneider, MD principal investigator
Cincinnati Childrens Hospital Medical Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of Facetime with child and parents during induction in people with Anxiety and Surgery, run by Children's Hospital Medical Center, Cincinnati at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Virtual presence cause delays in operating room (time frame: During procedure). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.