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| Name | Class |
|---|---|
| Northeastern University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Parental Perceived Impact and Impressions Assessed Through the Parental PIRA Survey | This survey assesses parental opinions about the PIRA. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda Bulich | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Waltham | Massachusetts | 02453 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Education | This group will receive the standard of care pre-operative education that all children get prior to ORL surgery at BCH Waltham. |
| FG001 | Pediatric Interactive Relational Agent (PIRA) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 26, 2022 |
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The research team member handing out surveys and observing children for anxiety are masked. The PACU nurse observing for emergence agitation post-op is also masked.
| immediately postop in the PACU - 1 day |
| 2-10 days before the day of surgery |
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.
| COMPLETED |
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| NOT COMPLETED |
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Overall number of baseline participants refers to parent/guardian-child dyads. Baseline Measure Information (Age, Sex, Race/Ethnicity, etc) was not collected on the child participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Education | This group will receive the standard of care pre-operative education that all children get prior to ORL surgery at BCH Waltham. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Parental Age | 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. | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Parental sex | 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. | Count of Participants | Participants |
| ||||||||||||||
| Ethnicity (NIH/OMB) | Parental Ethnicity | 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. | Count of Participants | Participants |
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| Race (NIH/OMB) | Parental Race | 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. | Count of Participants | Participants |
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| Education Level of Parent/Guardian | 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. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | Preoperative Period - 1 day |
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| Primary | 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 | Posted | Median | Inter-Quartile Range | score on a scale | Preoperative period- 1 day |
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| Primary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | immediately postop in the PACU - 1 day |
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| Secondary | Parental Perceived Impact and Impressions Assessed Through the Parental PIRA Survey | This survey assesses parental opinions about the PIRA. | Not Posted | Preoperative period - 1 day | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | 2-10 days before the day of surgery | Participants |
Adverse even data were collected for length of time participants were in the study, which was up to 10 days.
No adverse events were anticipated as this was a minimal risk study. As such, no adverse events occurred (all recorded deaths and adverse events are currently reported, as below). Adverse event reporting is for the parent/child dyad. The child participants in both groups were observed for preop anxiety and postop emergence delirium yet were not included in other arms of the study and were considered the same dyad with the parent/guardian.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Education | This group will receive the standard of care pre-operative education that all children get prior to ORL surgery at BCH Waltham. | 0 | 35 | 0 | 35 | 0 | 35 |
| EG001 | 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. | 0 | 34 | 0 | 34 | 0 | 34 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Linda Bulich | Boston Children's Hospital | 617-355-7737 | linda.bulich@childrens.harvard.edu |
| Aug 18, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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