Trial Outcomes & Findings for A Single Blinded Randomized Controlled Trial Testing the Efficacy of a Pediatric Interactive Relational Agent vs. Standard Preoperative Education (NCT NCT04586569)

Last Updated: 2025-11-04

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

76 participants

Primary outcome timeframe

Preoperative Period - 1 day

Results posted on

2025-11-04

Participant Flow

Participant milestones

Participant milestones
Measure	Standard Education 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) 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. 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.
Overall Study STARTED	38	38
Overall Study COMPLETED	35	33
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard Education 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) 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. 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.
Overall Study Withdrawal by Subject	0	2
Overall Study No longer eligible	2	3
Overall Study Physician Decision	1	0

Baseline Characteristics

In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study. In the PIRA group, missing data is due to 4 dyads being withdrawn from the study and 1 parent did not answer the sex question on the survey.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Preoperative Period - 1 day

Outcome measures

Outcome measures
Measure	Pediatric Interactive Relational Agent (PIRA) n=34 Participants 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. 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.	Standard Education n=35 Participants This group will receive the standard of care pre-operative education that all children get prior to ORL surgery at BCH Waltham.
Child Anxiety in Preoperative Waiting Room Using the Modified Yale Preoperative Anxiety Scale (mYPAS) for Child Anxiety	25 score on a scale Interval 25.0 to 25.0	25 score on a scale Interval 25.0 to 31.3

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Pediatric Interactive Relational Agent (PIRA) n=33 Participants 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. 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.	Standard Education n=35 Participants This group will receive the standard of care pre-operative education that all children get prior to ORL surgery at BCH Waltham.
Parental Anxiety in Preoperative Waiting Room Using the Parental State-Trait Anxiety Inventory (STAI) for Parental Anxiety	48 score on a scale Interval 43.0 to 50.0	46 score on a scale Interval 42.0 to 50.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Pediatric Interactive Relational Agent (PIRA) n=33 Participants 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. 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.	Standard Education n=35 Participants This group will receive the standard of care pre-operative education that all children get prior to ORL surgery at BCH Waltham.
Emergence From Anesthesia: Presence or Absence of Emergence Agitation/Delirium (ED) Using the PACU Pediatric Anesthesia Emergence Delirium (PAED) for Anesthesia Scale	4 score on a scale Interval 0.0 to 7.0	3 score on a scale Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: Preoperative period - 1 day

This survey assesses parental opinions about the PIRA.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2-10 days before the day of surgery

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.

Outcome measures

Outcome data not reported

Adverse Events

Standard Education

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pediatric Interactive Relational Agent (PIRA)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Linda Bulich

Boston Children's Hospital

Phone: 617-355-7737

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Standard Education n=38 Participants 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) n=38 Participants 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. 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.	Total n=76 Participants Total of all reporting groups
Sex: Female, Male Female	31 Participants n=35 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study. In the PIRA group, missing data is due to 4 dyads being withdrawn from the study and 1 parent did not answer the sex question on the survey.	32 Participants n=33 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study. In the PIRA group, missing data is due to 4 dyads being withdrawn from the study and 1 parent did not answer the sex question on the survey.	63 Participants n=68 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study. In the PIRA group, missing data is due to 4 dyads being withdrawn from the study and 1 parent did not answer the sex question on the survey.
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=35 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study. In the PIRA group, missing data is due to 4 dyads being withdrawn from the study and 1 parent did not answer the ethnicity question on the survey.	1 Participants n=33 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study. In the PIRA group, missing data is due to 4 dyads being withdrawn from the study and 1 parent did not answer the ethnicity question on the survey.	2 Participants n=68 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study. In the PIRA group, missing data is due to 4 dyads being withdrawn from the study and 1 parent did not answer the ethnicity question on the survey.
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=35 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study. In the PIRA group, missing data is due to 4 dyads being withdrawn from the study and 1 parent did not answer the ethnicity question on the survey.	32 Participants n=33 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study. In the PIRA group, missing data is due to 4 dyads being withdrawn from the study and 1 parent did not answer the ethnicity question on the survey.	63 Participants n=68 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study. In the PIRA group, missing data is due to 4 dyads being withdrawn from the study and 1 parent did not answer the ethnicity question on the survey.
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=35 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study. In the PIRA group, missing data is due to 4 dyads being withdrawn from the study and 1 parent did not answer the ethnicity question on the survey.	0 Participants n=33 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study. In the PIRA group, missing data is due to 4 dyads being withdrawn from the study and 1 parent did not answer the ethnicity question on the survey.	3 Participants n=68 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study. In the PIRA group, missing data is due to 4 dyads being withdrawn from the study and 1 parent did not answer the ethnicity question on the survey.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=35 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study prior to survey completion. In the PIRA group, 4 dyads were withdrawn from the study prior to survey completion and 1 parent did not answer the Race question.	0 Participants n=33 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study prior to survey completion. In the PIRA group, 4 dyads were withdrawn from the study prior to survey completion and 1 parent did not answer the Race question.	0 Participants n=68 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study prior to survey completion. In the PIRA group, 4 dyads were withdrawn from the study prior to survey completion and 1 parent did not answer the Race question.
Race (NIH/OMB) Asian	0 Participants n=35 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study prior to survey completion. In the PIRA group, 4 dyads were withdrawn from the study prior to survey completion and 1 parent did not answer the Race question.	1 Participants n=33 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study prior to survey completion. In the PIRA group, 4 dyads were withdrawn from the study prior to survey completion and 1 parent did not answer the Race question.	1 Participants n=68 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study prior to survey completion. In the PIRA group, 4 dyads were withdrawn from the study prior to survey completion and 1 parent did not answer the Race question.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=35 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study prior to survey completion. In the PIRA group, 4 dyads were withdrawn from the study prior to survey completion and 1 parent did not answer the Race question.	0 Participants n=33 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study prior to survey completion. In the PIRA group, 4 dyads were withdrawn from the study prior to survey completion and 1 parent did not answer the Race question.	0 Participants n=68 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study prior to survey completion. In the PIRA group, 4 dyads were withdrawn from the study prior to survey completion and 1 parent did not answer the Race question.
Race (NIH/OMB) More than one race	3 Participants n=35 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study prior to survey completion. In the PIRA group, 4 dyads were withdrawn from the study prior to survey completion and 1 parent did not answer the Race question.	0 Participants n=33 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study prior to survey completion. In the PIRA group, 4 dyads were withdrawn from the study prior to survey completion and 1 parent did not answer the Race question.	3 Participants n=68 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study prior to survey completion. In the PIRA group, 4 dyads were withdrawn from the study prior to survey completion and 1 parent did not answer the Race question.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=35 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study prior to survey completion. In the PIRA group, 4 dyads were withdrawn from the study prior to survey completion and 1 parent did not answer the Race question.	1 Participants n=33 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study prior to survey completion. In the PIRA group, 4 dyads were withdrawn from the study prior to survey completion and 1 parent did not answer the Race question.	1 Participants n=68 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study prior to survey completion. In the PIRA group, 4 dyads were withdrawn from the study prior to survey completion and 1 parent did not answer the Race question.
Age, Continuous	40 years n=34 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study due to surgery cancellation, research staff unavailability, inconsistent communication from parent, and 1 because the parent did not answer the age question on the survey. In the PIRA group, missing data is due to 4 dyads being withdrawn from the study due to the same reasons as above, and 2 parents did not answer the question on the survey.	38 years n=32 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study due to surgery cancellation, research staff unavailability, inconsistent communication from parent, and 1 because the parent did not answer the age question on the survey. In the PIRA group, missing data is due to 4 dyads being withdrawn from the study due to the same reasons as above, and 2 parents did not answer the question on the survey.	38 years n=66 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study due to surgery cancellation, research staff unavailability, inconsistent communication from parent, and 1 because the parent did not answer the age question on the survey. In the PIRA group, missing data is due to 4 dyads being withdrawn from the study due to the same reasons as above, and 2 parents did not answer the question on the survey.
Sex: Female, Male Male	4 Participants n=35 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study. In the PIRA group, missing data is due to 4 dyads being withdrawn from the study and 1 parent did not answer the sex question on the survey.	1 Participants n=33 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study. In the PIRA group, missing data is due to 4 dyads being withdrawn from the study and 1 parent did not answer the sex question on the survey.	5 Participants n=68 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study. In the PIRA group, missing data is due to 4 dyads being withdrawn from the study and 1 parent did not answer the sex question on the survey.
Race (NIH/OMB) Black or African American	1 Participants n=35 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study prior to survey completion. In the PIRA group, 4 dyads were withdrawn from the study prior to survey completion and 1 parent did not answer the Race question.	3 Participants n=33 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study prior to survey completion. In the PIRA group, 4 dyads were withdrawn from the study prior to survey completion and 1 parent did not answer the Race question.	4 Participants n=68 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study prior to survey completion. In the PIRA group, 4 dyads were withdrawn from the study prior to survey completion and 1 parent did not answer the Race question.
Race (NIH/OMB) White	31 Participants n=35 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study prior to survey completion. In the PIRA group, 4 dyads were withdrawn from the study prior to survey completion and 1 parent did not answer the Race question.	28 Participants n=33 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study prior to survey completion. In the PIRA group, 4 dyads were withdrawn from the study prior to survey completion and 1 parent did not answer the Race question.	59 Participants n=68 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study prior to survey completion. In the PIRA group, 4 dyads were withdrawn from the study prior to survey completion and 1 parent did not answer the Race question.
Education Level of Parent/Guardian High School Diploma	4 Participants n=35 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study prior to survey completion. In the PIRA group, 4 dyads were withdrawn from the study prior to survey completion and 1 parent did not answer the education question.	1 Participants n=33 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study prior to survey completion. In the PIRA group, 4 dyads were withdrawn from the study prior to survey completion and 1 parent did not answer the education question.	5 Participants n=68 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study prior to survey completion. In the PIRA group, 4 dyads were withdrawn from the study prior to survey completion and 1 parent did not answer the education question.
Education Level of Parent/Guardian Associate's Degree	3 Participants n=35 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study prior to survey completion. In the PIRA group, 4 dyads were withdrawn from the study prior to survey completion and 1 parent did not answer the education question.	4 Participants n=33 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study prior to survey completion. In the PIRA group, 4 dyads were withdrawn from the study prior to survey completion and 1 parent did not answer the education question.	7 Participants n=68 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study prior to survey completion. In the PIRA group, 4 dyads were withdrawn from the study prior to survey completion and 1 parent did not answer the education question.
Education Level of Parent/Guardian Bachelor's Degree	9 Participants n=35 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study prior to survey completion. In the PIRA group, 4 dyads were withdrawn from the study prior to survey completion and 1 parent did not answer the education question.	12 Participants n=33 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study prior to survey completion. In the PIRA group, 4 dyads were withdrawn from the study prior to survey completion and 1 parent did not answer the education question.	21 Participants n=68 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study prior to survey completion. In the PIRA group, 4 dyads were withdrawn from the study prior to survey completion and 1 parent did not answer the education question.
Education Level of Parent/Guardian Master's Degree	12 Participants n=35 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study prior to survey completion. In the PIRA group, 4 dyads were withdrawn from the study prior to survey completion and 1 parent did not answer the education question.	15 Participants n=33 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study prior to survey completion. In the PIRA group, 4 dyads were withdrawn from the study prior to survey completion and 1 parent did not answer the education question.	27 Participants n=68 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study prior to survey completion. In the PIRA group, 4 dyads were withdrawn from the study prior to survey completion and 1 parent did not answer the education question.
Education Level of Parent/Guardian Doctoral Degree	7 Participants n=35 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study prior to survey completion. In the PIRA group, 4 dyads were withdrawn from the study prior to survey completion and 1 parent did not answer the education question.	1 Participants n=33 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study prior to survey completion. In the PIRA group, 4 dyads were withdrawn from the study prior to survey completion and 1 parent did not answer the education question.	8 Participants n=68 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study prior to survey completion. In the PIRA group, 4 dyads were withdrawn from the study prior to survey completion and 1 parent did not answer the education question.
Education Level of Parent/Guardian Did Not Graduate High School	0 Participants n=35 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study prior to survey completion. In the PIRA group, 4 dyads were withdrawn from the study prior to survey completion and 1 parent did not answer the education question.	0 Participants n=33 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study prior to survey completion. In the PIRA group, 4 dyads were withdrawn from the study prior to survey completion and 1 parent did not answer the education question.	0 Participants n=68 Participants • In the Standard Education group, missing data is due to 3 dyads being withdrawn from the study prior to survey completion. In the PIRA group, 4 dyads were withdrawn from the study prior to survey completion and 1 parent did not answer the education question.