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Family-Centered Behavioral Preparation for Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00261261
First Posted: December 2, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Center for Research Resources (NCRR)
Information provided by:
Yale University
November 30, 2005
December 2, 2005
December 9, 2005
January 2001
Not Provided
  • Anxiety in children: modified Yale Preoperative anxiety scale
  • Anxiety in parents: STAI
Same as current
No Changes Posted
  • Emergence delirium
  • Analgesic consumption
  • Time to discharge from recovery room
Same as current
Not Provided
Not Provided
 
Family-Centered Behavioral Preparation for Surgery
Study of the ADVANCE Behavioral Preparation Program for Children and Their Parents
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Anxiety
  • Behavioral: ADVANCE
  • Drug: Midazolam
  • Procedure: Parental presence
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
December 2004
Not Provided

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.

Exclusion Criteria:

  • Children with a history of chronic illness, prematurity (fewer than 36 weeks gestation) or reported developmental delay
Sexes Eligible for Study: All
2 Years to 10 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00261261
ADVANCE
Not Provided
Not Provided
Not Provided
Not Provided
Yale University
National Center for Research Resources (NCRR)
Principal Investigator: Zeev N Kain, MD Yale University
Yale University
November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP