Anesthesia, Anesthesia Emergence Delirium, Procedural Anxiety
Conditions
Keywords
education
Brief summary
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.
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.
Interventions
OTHERPediatric 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.
Sponsors
Northeastern University
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
4 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child Anxiety in Preoperative Waiting Room Using the Modified Yale Preoperative Anxiety Scale (mYPAS) for Child Anxiety | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parental Perceived Impact and Impressions Assessed Through the Parental PIRA Survey | Preoperative period - 1 day | This survey assesses parental opinions about the PIRA. |
| Parental Utilization | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Education This group will receive the standard of care pre-operative education that all children get prior to ORL surgery at BCH Waltham. | 38 |
| 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. | 38 |
| Total | 76 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | No longer eligible | 2 | 3 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Standard Education | Total | Pediatric Interactive Relational Agent (PIRA) |
|---|---|---|---|
| Age, Continuous | 40 years | 38 years | 38 years |
| Education Level of Parent/Guardian Associate's Degree | 3 Participants | 7 Participants | 4 Participants |
| Education Level of Parent/Guardian Bachelor's Degree | 9 Participants | 21 Participants | 12 Participants |
| Education Level of Parent/Guardian Did Not Graduate High School | 0 Participants | 0 Participants | 0 Participants |
| Education Level of Parent/Guardian Doctoral Degree | 7 Participants | 8 Participants | 1 Participants |
| Education Level of Parent/Guardian High School Diploma | 4 Participants | 5 Participants | 1 Participants |
| Education Level of Parent/Guardian Master's Degree | 12 Participants | 27 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 63 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 31 Participants | 59 Participants | 28 Participants |
| Sex: Female, Male Female | 31 Participants | 63 Participants | 32 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 34 |
| other Total, other adverse events | 0 / 35 | 0 / 34 |
| serious Total, serious adverse events | 0 / 35 | 0 / 34 |
Outcome results
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.
Time frame: Preoperative Period - 1 day
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Education | Child Anxiety in Preoperative Waiting Room Using the Modified Yale Preoperative Anxiety Scale (mYPAS) for Child Anxiety | 25 score on a scale |
| Pediatric Interactive Relational Agent (PIRA) | Child Anxiety in Preoperative Waiting Room Using the Modified Yale Preoperative Anxiety Scale (mYPAS) for Child Anxiety | 25 score on a scale |
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.
Time frame: immediately postop in the PACU - 1 day
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Education | Emergence From Anesthesia: Presence or Absence of Emergence Agitation/Delirium (ED) Using the PACU Pediatric Anesthesia Emergence Delirium (PAED) for Anesthesia Scale | 3 score on a scale |
| Pediatric Interactive Relational Agent (PIRA) | 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 |
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
Time frame: Preoperative period- 1 day
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Education | Parental Anxiety in Preoperative Waiting Room Using the Parental State-Trait Anxiety Inventory (STAI) for Parental Anxiety | 46 score on a scale |
| Pediatric Interactive Relational Agent (PIRA) | Parental Anxiety in Preoperative Waiting Room Using the Parental State-Trait Anxiety Inventory (STAI) for Parental Anxiety | 48 score on a scale |
Secondary
Parental Perceived Impact and Impressions Assessed Through the Parental PIRA Survey
This survey assesses parental opinions about the PIRA.
Time frame: Preoperative period - 1 day
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.
Time frame: 2-10 days before the day of surgery