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Family-Centered Behavioral Preparation for Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00261261
Enrollment
400
Registered
2005-12-02
Start date
2001-01-31
Completion date
2004-12-31
Last updated
2005-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety

Keywords

children, anxiety, behavioral preparation, family, surgery, 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.

Interventions

BEHAVIORALADVANCE
DRUGMidazolam

Sponsors

National Center for Research Resources (NCRR)
CollaboratorNIH
Yale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
2 Years to 10 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Emergence delirium
Analgesic consumption
Time to discharge from recovery room

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026