AnxietyNCT05834049
Virtual Parental Presence on Induction of Anesthesia vs Premedication With Midazolam
A study testing Virtual Parental Presence on Induction of Anesthesia and Midazolam in people with Anxiety and Surgery, run by Stanford University.
Trial summary
This multi-center, prospective, clinical trial targets recruiting children undergoing inhalational induction of anesthesia. The primary objective of this study is to assess the Modified Yale Preoperative Anxiety Scale during induction between children receiving oral midazolam 0.5 mg/kg (max 20 mg) versus virtual… Read more about this study
- Who is it for?
- Ages 4 to 8 years
- What is being tested?
- Virtual Parental Presence on Induction of Anesthesia and Midazolam
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 30 Dec 2027
- 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 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children from ages 4 years to 8 years old undergoing outpatient surgery
- children identified as needing premedication
- 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 in whom midazolam may be medically contraindicated per the discretion of the anesthesia care team
- children with language barrier
- children who are not accompanied by someone able to consent (ie legal guardian)
Show all 15Show fewer
- 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 withdrawal 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 precautions in the operating room
- receipt of any type of medical sedative prior to induction of anesthesia, including (but not limited to) ketamine, and/or dexmedetomidine.
About this study
Official title: Virtual Parental Presence on Induction of Anesthesia Versus Premedication With Midazolam: A Non-Inferiority Study
This multi-center, prospective, clinical trial targets recruiting children undergoing inhalational induction of anesthesia. The primary objective of this study is to assess the Modified Yale Preoperative Anxiety Scale during induction between children receiving oral midazolam 0.5 mg/kg (max 20 mg) versus virtual parental presence on induction of anesthesia. Patients will be randomized to one of two groups by block randomization.
- Being tested
- Virtual Parental Presence on Induction of Anesthesia, Midazolam
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Parental Presence on Induction of AnesthesiaBehavioural
Also called VPPIA
Apple Inc's FaceTime™ video application will be used when the child is taken to the operating room
MidazolamBehavioural
Preoperative midazolam (0.5 mg/kg of oral midazolam with a maximum dose of 20mg) will be given unless medically contraindicated.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Parental Presence on Induction of Anesthesia group | Experimental | Use of Facetime with child and parents during induction Receives: Behavioral: Virtual Parental Presence on Induction of Anesthesia |
| Midazolam Group | Experimental | 0.5 mg/kg oral midazolam (max 20 mg) will be given preoperatively. Receives: Behavioral: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Anxiety in children
We will be using the modified Yale Preoperative Anxiety Scale (mYPAS) which was developed specifically to measure anxiety at anesthesia induction. It looks at activity, facial expression, alertness and arousal, vocalization and interaction with adults. It has a good validity against the State-Trait Anxiety Inventory for Children, as well as good intra and inter-observer reliability. mYPAS contains 5 items (activity, vocalisation, emotional expressivity, state of apparent arousal, and use of parent). The total score ranges from 0 to 22. Higher scores mean higher levels of anxiety.
Measured: baseline, immediately after the intervention
Secondary outcomes (2)
Induction compliance
The Induction Compliance Checklist (ICC) is a validated observational scale, used to describe the compliance of a child during induction of anesthesia. ICC contains 10 items. Score ranges from 0 to 1. 0 point indicates the behavior is not observed while 1 point means behavior is observed.
Measured: immediately during anesthetic induction
Change of parental anxiety
The State-Trait Anxiety Inventory (STAI) is the gold standard for assessing anxiety in adults and has been used in over 1000 studies. It is comprises 20 questions. The total score ranges from 0-63. 0-9 indicates normal or no anxiety; 10-18 indicates mild to moderate anxiety; 19-29 indicates moderate to severe anxiety; and 30-63 indicates severe anxiety.
Measured: baseline, immediately after anesthetic induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start1 Jul 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Why it stopped: The collaborator has no intention to initiate the study at this moment.
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.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Nationwide Children's Hospital
- Responsible party
- Principal investigator, Thomas Caruso, Stanford University
- Investigators
- Vanessa Olbrecht, MD, MBA, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834049
- Sponsor's protocol ID
- 69571
- Status last verified
- Apr 2026
- First submitted
- 11 Apr 2023
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Parental Presence on Induction of Anesthesia Versus Premedication With Midazolam: A Non-Inferiority Study
- ClinicalTrials.gov ID
- NCT05834049
- Acronym / sponsor ID
- 69571
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The collaborator has no intention to initiate the study at this moment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Nationwide Children's Hospital
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 28 Apr 2023 (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.
This multi-center, prospective, clinical trial targets recruiting children undergoing inhalational induction of anesthesia. The primary objective of this study is to assess the Modified Yale Preoperative Anxiety Scale during induction between children receiving oral midazolam 0.5 mg/kg (max 20 mg) versus virtual parental presence on induction of anesthesia. Patients will be randomized to one of two groups by block randomization.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Parental Presence on Induction of Anesthesia group | Experimental | Behavioral: Virtual Parental Presence on Induction of AnesthesiaUse of Facetime with child and parents during induction |
| Midazolam Group | Experimental | Behavioral: Midazolam0.5 mg/kg oral midazolam (max 20 mg) will be given preoperatively. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- children from ages 4 years to 8 years old undergoing outpatient surgery
- children identified as needing premedication
- ASA physical status I, II or III
- planned inhalational induction
- children presenting from home prior to surgery (not an inpatient)
Key exclusion criteria (15 listed)
- children with developmental delay
- children with psychological / emotional disorders
- children with altered mental status
- children in whom midazolam may be medically contraindicated per the discretion of the anesthesia care team
- children with language barrier
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 |
|---|---|---|
| Virtual Parental Presence on Induction of AnesthesiaAlso: VPPIAApple Inc's FaceTime™ video application will be used when the child is taken to the operating room | Behavioural | Virtual Parental Presence on Induction of Anesthesia group |
| MidazolamPreoperative midazolam (0.5 mg/kg of oral midazolam with a maximum dose of 20mg) will be given unless medically contraindicated. | Behavioural | Midazolam Group |
Primary outcome
Change of Anxiety in children
Time frame: baseline, immediately after the intervention
We will be using the modified Yale Preoperative Anxiety Scale (mYPAS) which was developed specifically to measure anxiety at anesthesia induction. It looks at activity, facial expression, alertness and arousal, vocalization and interaction with adults. It has a good validity against the State-Trait Anxiety Inventory for Children, as well as good intra and inter-observer reliability. mYPAS contains 5 items (activity, vocalisation, emotional expressivity, state of apparent arousal, and use of parent). The total score ranges from 0 to 22. Higher scores mean higher levels of anxiety.
2 secondary outcomes
Induction compliance
Time frame: immediately during anesthetic induction
Change of parental anxiety
Time frame: baseline, immediately after anesthetic induction
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Vanessa Olbrecht, MD, MBA principal investigator
Nationwide Children's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Parental Presence on Induction of Anesthesia and Midazolam in people with Anxiety and Surgery, run by Stanford University.
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 6 inclusion and 15 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: withdrawn, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Change of Anxiety in children (time frame: baseline, immediately after the intervention). 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 24 Apr 2026.