Study of the ADVANCE Behavioral Preparation Program for Children and Their Parents

Yale University1 site in 1 country400 target enrollmentJanuary 2001

ConditionsAnxiety

DrugsMidazolam

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Anxiety
Sponsor: Yale University
Enrollment: 400
Locations: 1
Primary Endpoint: Anxiety in children: modified Yale Preoperative anxiety scale
Status: Completed
Last Updated: 20 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Children experience significant anxiety and distress during the preoperative period. Currently available interventions are ineffective and/or associated with significant disadvantages. These interventions exclusively target the child and do not attempt to reduce parental anxiety. Based on an integration of the literature in both the anesthesia and psychological milieus, we developed ADVANCE, a behaviorally oriented anxiety reduction program for children undergoing surgery that targets the family as a whole.

Detailed Description

Children and their parents (n=408) were randomly assigned to one of four groups: 1) Control: received standard of care, 2) PPIA: received standard parental presence during induction of anesthesia, 3) ADVANCE: received family-centered behavioral preparation, and 4) oral Midazolam. We assessed the effect of group assignment on anxiety levels and postoperative outcomes.

Registry

clinicaltrials.gov

Start Date

January 2001

End Date

December 2004

Last Updated

20 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Yale University

Eligibility Criteria

Inclusion Criteria

•Children 2-10 years old who were in good health (American Society of Anesthesiology physical status I-II) and who were undergoing general anesthesia and elective, outpatient surgery, and their parents.