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Completed

NCT Number: NCT00261261

Family-Centered Behavioral Preparation for Surgery

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University

New Haven, Connecticut, 06520, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ADVANCE

Behavioral

midazolam

Drug

Parental presence

Procedure

Primary outcomes

  1. Anxiety in children: modified Yale Preoperative anxiety scale

  2. Anxiety in parents: STAI

Secondary outcomes

  1. Emergence delirium

  2. Analgesic consumption

  3. Time to discharge from recovery room

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Center for Research Resources (NCRR)

Registry information

Official study title

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

Important dates

Study start
2001
Study completion
2004
First posted
Dec 2, 2005
Registry last updated
Dec 2, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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