Family-Centered Behavioral Preparation for Surgery

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00261261
First received: November 30, 2005
Last updated: NA
Last verified: November 2005
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Ages Eligible for Study:   2 Years to 10 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00261261

Locations
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Zeev N Kain, MD Yale University
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00261261     History of Changes
Other Study ID Numbers: ADVANCE
Study First Received: November 30, 2005
Last Updated: November 30, 2005
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Midazolam
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on August 28, 2014