Family-Centered Behavioral Preparation for Surgery

This study has been completed.

Sponsor:

Collaborator:

National Center for Research Resources (NCRR)

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

Tracking Information

First Received Date ^ICMJE

November 30, 2005

Last Updated Date

November 30, 2005

Start Date ^ICMJE

January 2001

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Anxiety in children: modified Yale Preoperative anxiety scale
Anxiety in parents: STAI

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Emergence delirium
Analgesic consumption
Time to discharge from recovery room

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Family-Centered Behavioral Preparation for Surgery

Official Title ^ICMJE

Study of the ADVANCE Behavioral Preparation Program for Children and Their Parents

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment

Condition ^ICMJE

Anxiety

Intervention ^ICMJE

Behavioral: ADVANCE
Drug: Midazolam
Procedure: Parental presence

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

400

Completion Date

December 2004

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

2 Years to 10 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00261261

Other Study ID Numbers ^ICMJE

ADVANCE

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Yale University

Collaborators ^ICMJE

National Center for Research Resources (NCRR)

Investigators ^ICMJE

Principal Investigator:

Zeev N Kain, MD

Yale University

Information Provided By

Yale University

Verification Date

November 2005

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

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