Ignite Creation Date:
2024-05-05 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00261261
Status:
COMPLETED
Last Update Posted:
2005-12-02
First Post:
2005-11-30
Brief Title:
Family-Centered Behavioral Preparation for Surgery
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Study of the ADVANCE Behavioral Preparation Program for Children and Their Parents
Status:
COMPLETED
Status Verified Date:
2005-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Children experience significant anxiety and distress during the preoperative period Currently available interventions are ineffective andor 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 n408 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None