NCT00261261

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Jan 2001

Longer than P75 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2005

Completed
Last Updated

December 2, 2005

Status Verified

November 1, 2005

First QC Date

November 30, 2005

Last Update Submit

November 30, 2005

Conditions

Anxiety

Keywords

childrenanxietybehavioral preparationfamilysurgeryparents

Outcome Measures

Primary Outcomes (2)

  • Anxiety in children: modified Yale Preoperative anxiety scale

  • Anxiety in parents: STAI

Secondary Outcomes (3)

  • Emergence delirium

  • Analgesic consumption

  • Time to discharge from recovery room

Interventions

ADVANCEBEHAVIORAL
MidazolamDRUG
Parental presencePROCEDURE

Eligibility Criteria

Age2 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Children with a history of chronic illness, prematurity (fewer than 36 weeks gestation) or reported developmental delay

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Zeev N Kain, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 30, 2005

First Posted

December 2, 2005

Study Start

January 1, 2001

Study Completion

December 1, 2004

Last Updated

December 2, 2005

Record last verified: 2005-11

Locations

US(1)