Status:
COMPLETED
Family-Centered Behavioral Preparation for Surgery
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Center for Research Resources (NCRR)
Conditions:
Anxiety
Eligibility:
All Genders
2-10 years
Phase:
NA
Brief Summary
Children experience significant anxiety and distress during the preoperative period. Currently available interventions are ineffective and/or associated with significant disadvantages. These intervent...
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) ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Children with a history of chronic illness, prematurity (fewer than 36 weeks gestation) or reported developmental delay
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00261261
Start Date
January 1 2001
End Date
December 1 2004
Last Update
December 2 2005
Active Locations (1)
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1
Yale University
New Haven, Connecticut, United States, 06520