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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
  Purpose
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.

Condition Intervention
Anxiety Behavioral: ADVANCE Drug: Midazolam Procedure: Parental presence

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Study of the ADVANCE Behavioral Preparation Program for Children and Their Parents

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Anxiety in children: modified Yale Preoperative anxiety scale
  • Anxiety in parents: STAI

Secondary Outcome Measures:
  • Emergence delirium
  • Analgesic consumption
  • Time to discharge from recovery room

Estimated Enrollment: 400
Study Start Date: January 2001
Estimated Study Completion Date: December 2004
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Exclusion Criteria:

  • Children with a history of chronic illness, prematurity (fewer than 36 weeks gestation) or reported developmental delay
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00261261


Locations
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
National Center for Research Resources (NCRR)
Investigators
Principal Investigator: Zeev N Kain, MD Yale University
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00261261     History of Changes
Other Study ID Numbers: ADVANCE
First Submitted: November 30, 2005
First Posted: December 2, 2005
Last Update Posted: December 9, 2005
Last Verified: November 2005

Keywords provided by Yale University:
children
anxiety
behavioral preparation
family
surgery
parents

Additional relevant MeSH terms:
Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action