AnesthesiaNCT04586569

A Single Blinded Randomized Controlled Trial Testing the Efficacy of a Pediatric Interactive Relational Agent vs. Standard Preoperative Education

A study testing Pediatric Interactive Relational Agent (PIRA) in people with Anesthesia and Anesthesia Emergence Delirium, run by Boston Children's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 4 to 10 years
Conditions the study is for: Anesthesia, Anesthesia Emergence Delirium, Procedural Anxiety
What is being tested?: Pediatric Interactive Relational Agent (PIRA)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 76 participants
Where: 1 siteUnited States
Study dates: 6 Jul 2021to 19 Oct 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 10 years
All sexes
No healthy volunteers
Child

Who may be able to join

Parents (age 18+) and their children, ages 4 through 10 years old, who are undergoing general anesthesia and elective, outpatient ORL surgery at BCH Waltham
American Society of Anesthesiology (ASA) physical status I or II
Both parents and their children must be fluent in English

Who cannot join

Parents without reliable internet access through a tablet or computer
Parents of children with diagnosed developmental delays
Parents who have children who have had previous surgical history under general anesthesia
Parents of children involved in other anesthesia-related studies at BCH

Trial locations and contacts

1 site in 1 country.

United States1 site

Boston Children's Hospital
Waltham, Massachusetts, 02453

Other trials in United States

About this study

The purpose of this study is to determine the efficacy of enhanced preoperative education using a Pediatric Interactive Relational Agent (PIRA), designed for children aged 4 through 10 years and their families, compared to the standard preoperative education currently provided. Specifically, the study aimed to evaluate differences in parent/child preoperative anxiety, and child experience with emergence from anesthesia. A secondary aim was to evaluate the child's and the parent's access and utilization the Pediatric Interactive Relational Agent as well as parental satisfaction and difficulties with the tool.

Read the detailed description

This summary is a change from the original study/title where the secondary aim (from the original submission) is now the primary aim of the study and the primary aim (from the original submission) is now the secondary aim. This change was made following the first revision of the manuscript by the Editor in Chief and two separate reviewers. The manuscript was then rejected after a second review despite agreeing to reverse the primary and secondary outcomes as suggested by the reviewers. The Editor in Chief rejected this second submission stating that the newest revision (second revision) was not consistent with my original submission to ClinicalTrials.org. I am interested in submitting this manuscript to another journal yet wanted the changes to be updated in ClinicalTrials.org before resubmission.

Conditions: Anesthesia, Anesthesia Emergence Delirium, Procedural Anxiety
Being tested: Pediatric Interactive Relational Agent (PIRA)
Keywords: education
Medical subject headings: Emergence Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pediatric Interactive Relational Agent (PIRA)Other
The PIRA is an interactive, online tool used to educate children and families about their child's upcoming surgical and anesthesia experience.

Study groups in NCT04586569
Study group	Role	What they receive
Standard Education	No intervention	This group will receive the standard of care pre-operative education that all children get prior to ORL surgery at BCH Waltham.
Pediatric Interactive Relational Agent (PIRA)	Experimental	This group will receive the standard of care pre-operative education that all children get prior to ORL surgery at BCH Waltham and will be given access to an interactive, online educational tool for use prior to surgery. This Pediatric Interactive Relational Agent (PIRA) will be able to be accessed as many times as the family would like prior to surgery. Receives: Other: Pediatric Interactive Relational Agent (PIRA)

What is being measured

The primary outcome is the main question the study is designed to answer.

Child Anxiety in Preoperative Waiting Room Using the Modified Yale Preoperative Anxiety Scale (mYPAS) for Child Anxiety
The observational tool will be used to determine if there is a difference in anxiety between children who reviewed the PIRA and those who did not (control group). It will look at the incidence and severity of anxiety in children who received the PIRA vs. those who received standard preoperative education. This scale produces a score ranging from 22.92 to 100, with higher values indicating greater anxiety.
Measured: Preoperative Period - 1 day
Parental Anxiety in Preoperative Waiting Room Using the Parental State-Trait Anxiety Inventory (STAI) for Parental Anxiety
This survey will be used to determine if there a difference in anxiety between the parents who got the PIRA and those in the control group. It will look at the incidence and severity of anxiety in families who received the PIRA vs. those that received the standard education. Parental anxiety was assessed using the State-Trait Anxiety Inventory. The self-report anxiety instrument includes two separate 20-item subscales that measure trait (baseline) and state (situational) anxiety. The State-Trait Anxiety Inventory is scored from 20-80, with higher scores indicating more anxiety
Measured: Preoperative period- 1 day
Emergence From Anesthesia: Presence or Absence of Emergence Agitation/Delirium (ED) Using the PACU Pediatric Anesthesia Emergence Delirium (PAED) for Anesthesia Scale
This observational tool is used to determine if there is any effect on the incidence of emergence delirium for children who have more interactive preoperative education, such as PIRA, compared to standard information. The Post Anesthesia Emergence Delirium scale measures five behaviors, each rated on a five-point scale of 0 to 4. The scores are summed for a total score, with a maximum value of 20. An assessment of the internal consistency and reliability of the Post Anesthesia Emergence Delirium scale validated it for assessing emergence delirium in children recovering from general anesthesia.20 A score of >12 yields 100 percent sensitivity and 94.5 percent specificity for the diagnosis of emergence delirium. For this study, emergence delirium was considered present with a score of >12.
Measured: immediately postop in the PACU - 1 day

Secondary outcomes (2)

Parental Perceived Impact and Impressions Assessed Through the Parental PIRA Survey
This survey assesses parental opinions about the PIRA.
Measured: Preoperative period - 1 day
Parental Utilization
Interested in whether or not parents use the PIRA, frequency and duration of use and whether or not there were any barriers to its use. This will be assessed through the Parental PIRA survey.
Measured: 2-10 days before the day of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jul 202119 Oct 2023

First posted14 Oct 2020
Study start6 Jul 2021
Primary completion19 Oct 2023
Study completion19 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AnesthesiaStudies of the same condition, open and under way.
More trials run by Boston Children's HospitalThe 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Care provider, Outcomes assessor
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04586569
Sponsor's protocol ID: P00035987
Status last verified: Oct 2025
First submitted: 15 Sep 2020
Last updated: 4 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Anesthetic Technique and Quality of Recovery After Cesarean Delivery
Ceserean Section, Obstetric Quality of Recovery
Not yet recruiting
Dural Puncture Epidural With 27G vs 26G Needles Versus Standard Epidural for Elective Cesarean Delivery
Cesarean Section, Anesthesia, Obstetrical
Not yet recruiting
Monitored Anesthesia Care and Soft Tissue Infiltration With Local Anesthesia Feasibility Trial
Hip Fracture Surgeries, Intertrochanteric Fracture
Active, not recruiting
Comparison of Prophylactic Continuous Infusion of Norepinephrine, Ephedrine, and Their Combination for Prevention of Hypotension During Spinal Anaesthesia for Caesarean Delivery
Maternal Hypotension After Spinal Anesthesia
RecruitingPhase 4
The Electroencephalographic Mechanisms of Anesthesia and Human Consciousness
Consciousness, Level Altered

All Anesthesia trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Blinded Randomized Controlled Trial Testing the Efficacy of a Pediatric Interactive Relational Agent vs. Standard Preoperative Education
ClinicalTrials.gov ID: NCT04586569
Acronym / sponsor ID: P00035987
Conditions: Anesthesia, Anesthesia Emergence Delirium, Procedural Anxiety
Keywords: education
Study type: Interventional
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: Boston Children's HospitalUniversity, hospital or other
Collaborators: Northeastern University
Study start: 6 Jul 2021 (actual)
Primary completion: 19 Oct 2023 (actual)
Study completion: 19 Oct 2023 (actual)
First posted: 14 Oct 2020 (actual)
Results: Posted 4 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Standard Education	No intervention	–This group will receive the standard of care pre-operative education that all children get prior to ORL surgery at BCH Waltham.
Pediatric Interactive Relational Agent (PIRA)	Experimental	Other: Pediatric Interactive Relational Agent (PIRA)This group will receive the standard of care pre-operative education that all children get prior to ORL surgery at BCH Waltham and will be given access to an interactive, online educational tool for use prior to surgery. This Pediatric Interactive Relational Agent (PIRA) will be able to be accessed as many times as the family would like prior to surgery.

Who may qualify

Ages: 4 to 10 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Parents (age 18+) and their children, ages 4 through 10 years old, who are undergoing general anesthesia and elective, outpatient ORL surgery at BCH Waltham
American Society of Anesthesiology (ASA) physical status I or II
Both parents and their children must be fluent in English

Key exclusion criteria (4 listed)

Parents without reliable internet access through a tablet or computer
Parents of children with diagnosed developmental delays
Parents who have children who have had previous surgical history under general anesthesia
Parents of children involved in other anesthesia-related studies at BCH

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
Pediatric Interactive Relational Agent (PIRA)The PIRA is an interactive, online tool used to educate children and families about their child's upcoming surgical and anesthesia experience.	Other	Pediatric Interactive Relational Agent (PIRA)

Primary outcome

Child Anxiety in Preoperative Waiting Room Using the Modified Yale Preoperative Anxiety Scale (mYPAS) for Child Anxiety
Time frame: Preoperative Period - 1 day
The observational tool will be used to determine if there is a difference in anxiety between children who reviewed the PIRA and those who did not (control group). It will look at the incidence and severity of anxiety in children who received the PIRA vs. those who received standard preoperative education. This scale produces a score ranging from 22.92 to 100, with higher values indicating greater anxiety.
Parental Anxiety in Preoperative Waiting Room Using the Parental State-Trait Anxiety Inventory (STAI) for Parental Anxiety
Time frame: Preoperative period- 1 day
This survey will be used to determine if there a difference in anxiety between the parents who got the PIRA and those in the control group. It will look at the incidence and severity of anxiety in families who received the PIRA vs. those that received the standard education. Parental anxiety was assessed using the State-Trait Anxiety Inventory. The self-report anxiety instrument includes two separate 20-item subscales that measure trait (baseline) and state (situational) anxiety. The State-Trait Anxiety Inventory is scored from 20-80, with higher scores indicating more anxiety
Emergence From Anesthesia: Presence or Absence of Emergence Agitation/Delirium (ED) Using the PACU Pediatric Anesthesia Emergence Delirium (PAED) for Anesthesia Scale
Time frame: immediately postop in the PACU - 1 day
This observational tool is used to determine if there is any effect on the incidence of emergence delirium for children who have more interactive preoperative education, such as PIRA, compared to standard information. The Post Anesthesia Emergence Delirium scale measures five behaviors, each rated on a five-point scale of 0 to 4. The scores are summed for a total score, with a maximum value of 20. An assessment of the internal consistency and reliability of the Post Anesthesia Emergence Delirium scale validated it for assessing emergence delirium in children recovering from general anesthesia.20 A score of >12 yields 100 percent sensitivity and 94.5 percent specificity for the diagnosis of emergence delirium. For this study, emergence delirium was considered present with a score of >12.

2 secondary outcomes

Parental Perceived Impact and Impressions Assessed Through the Parental PIRA Survey
Time frame: Preoperative period - 1 day
Parental Utilization
Time frame: 2-10 days before the day of surgery

Results and safety

Results posted to the registry on 4 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Education	38	35
Pediatric Interactive Relational Agent (PIRA)	38	33

Primary outcome: Child Anxiety in Preoperative Waiting Room Using the Modified Yale Preoperative Anxiety Scale (mYPAS) for Child Anxiety

Time frame: Preoperative Period - 1 day. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Standard Education n = 35	Pediatric Interactive Relational Agent (PIRA) n = 34
Value	25 (25 to 31.3)	25 (25 to 25)

Primary outcome: Parental Anxiety in Preoperative Waiting Room Using the Parental State-Trait Anxiety Inventory (STAI) for Parental Anxiety

Time frame: Preoperative period- 1 day. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Standard Education n = 35	Pediatric Interactive Relational Agent (PIRA) n = 33
Value	46 (42 to 50)	48 (43 to 50)

Primary outcome: Emergence From Anesthesia: Presence or Absence of Emergence Agitation/Delirium (ED) Using the PACU Pediatric Anesthesia Emergence Delirium (PAED) for Anesthesia Scale

Time frame: immediately postop in the PACU - 1 day. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Standard Education n = 35	Pediatric Interactive Relational Agent (PIRA) n = 33
Value	3 (0 to 10)	4 (0 to 7)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse even data were collected for length of time participants were in the study, which was up to 10 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Education	0 of 35 (0%)	0 of 35 (0%)	0 of 35
Pediatric Interactive Relational Agent (PIRA)	0 of 34 (0%)	0 of 34 (0%)	0 of 34

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Anesthesia

RecruitingObservational study
Anesthetic Technique and Quality of Recovery After Cesarean Delivery
Ceserean Section, Obstetric Quality of Recovery
Not yet recruiting
Dural Puncture Epidural With 27G vs 26G Needles Versus Standard Epidural for Elective Cesarean Delivery
Cesarean Section, Anesthesia, Obstetrical
Not yet recruiting
Monitored Anesthesia Care and Soft Tissue Infiltration With Local Anesthesia Feasibility Trial
Hip Fracture Surgeries, Intertrochanteric Fracture
Active, not recruiting
Comparison of Prophylactic Continuous Infusion of Norepinephrine, Ephedrine, and Their Combination for Prevention of Hypotension During Spinal Anaesthesia for Caesarean Delivery
Maternal Hypotension After Spinal Anesthesia
RecruitingPhase 4
The Electroencephalographic Mechanisms of Anesthesia and Human Consciousness
Consciousness, Level Altered

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.

Linda Bulich principal investigator

Boston Children's Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Pediatric Interactive Relational Agent (PIRA) in people with Anesthesia and Anesthesia Emergence Delirium, run by Boston Children's Hospital at 1 site in United States.

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 3 inclusion and 4 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 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

Yes. Results are posted in the registry (first posted 4 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Child Anxiety in Preoperative Waiting Room Using the Modified Yale Preoperative Anxiety Scale (mYPAS) for Child Anxiety (time frame: Preoperative Period - 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04586569.

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 4 Nov 2025.