Family-Centered Behavioral Preparation for Surgery
- Conditions
- Anxiety
- Registration Number
- NCT00261261
- Lead Sponsor
- Yale University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
- 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.
- Children with a history of chronic illness, prematurity (fewer than 36 weeks gestation) or reported developmental delay
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Anxiety in children: modified Yale Preoperative anxiety scale Anxiety in parents: STAI
- Secondary Outcome Measures
Name Time Method Emergence delirium Analgesic consumption Time to discharge from recovery room
Trial Locations
- Locations (1)
Yale University
🇺🇸New Haven, Connecticut, United States