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Family-Centered Behavioral Preparation for Surgery

Yale University logo

Yale University

Status

Completed

Conditions

Anxiety

Treatments

Drug: Midazolam
Procedure: Parental presence
Behavioral: ADVANCE

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00261261
ADVANCE

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

2 to 10 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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