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Behavioural Intervention

PIRA for Emergence Delirium

N/A

Waitlist Available

Led By Linda Bulich

Research Sponsored by Boston Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2-10 days

Awards & highlights

Study Summary

This trial will test a new way of teaching kids about their surgery, to see if it eases anxiety and is more effective than the current method.

Eligible Conditions

Procedural Anxiety
Anesthesia
Anesthesia Emergence Delirium

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2-10 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2-10 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-10 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Parental Perceived Impact and Impressions assessed through the Parental PIRA Survey

Parental Utilization

Secondary outcome measures

Child Anxiety in Preoperative Waiting using the Modified Yale Preoperative Anxiety Scale (mYPAS) for Child Anxiety

Emergence from Anesthesia: Presence or absence of emergence agitation/delirium (ED) using the PACU Pediatric Anesthesia Emergence Delirium (PAED) for Anesthesia scale

Parental Anxiety in Preoperative Waiting using the Parental State-Trait Anxiety Inventory (STAI) for Parental Anxiety

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pediatric Interactive Relational Agent (PIRA)Experimental Treatment1 Intervention

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.

Group II: Standard EducationActive Control1 Intervention

This group will receive the standard of care pre-operative education that all children get prior to ORL surgery at BCH Waltham.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor

761 Previous Clinical Trials

5,579,656 Total Patients Enrolled

Northeastern UniversityOTHER

87 Previous Clinical Trials

59,486 Total Patients Enrolled

Linda BulichPrincipal InvestigatorBoston Children's Hospital

Media Library

Pediatric Interactive Relational Agent (PIRA) (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04586569 — N/A

Procedural Anxiety Research Study Groups: Standard Education, Pediatric Interactive Relational Agent (PIRA)

Procedural Anxiety Clinical Trial 2023: Pediatric Interactive Relational Agent (PIRA) Highlights & Side Effects. Trial Name: NCT04586569 — N/A

Pediatric Interactive Relational Agent (PIRA) (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04586569 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the enrollment size of this research endeavor?

"Affirmative. Publicly available data from clinicaltrials.gov reveals that this study, which was initially listed on July 6th 2021, is still seeking enrollees. In total, 76 volunteers must be sourced at one location for the trial to commence."

Answered by AI

Who meets the criteria to be eligible for this clinical experiment?

"The current medical trial is searching for 76 people aged between 4 and 10 that suffer from anxiety. In order to be considered, parents (who are 18+ years old) must also qualify alongside their children. Additional requirements include the need for English fluency amongst all participants as well as ASA physical status I or II when undergoing elective ORL surgery at BCH Waltham."

Answered by AI

Is it permissible for individuals under 25 years to partake in this medical research?

"To be eligible to take part in this investigation, participants must fall within the age range of 4 and 10 years old. There are 52 studies available for minors and 232 research opportunities open to those above 65 years of age."

Answered by AI

Are there presently any available slots for this experiment?

"According to clinicaltrials.gov, this experiment is actively searching for participants and has been since July 6th 2021. The most recent update was on November 16th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PIRA vs Standard Preoperative Education

Linda Bulich 2021. "PIRA vs Standard Preoperative Education". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04586569.