Psychological Influences on Postoperative Recovery

NCT00581139 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 241

Last updated 2023-09-07

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Summary

The primary hypothesis tested in this project is that the preoperative behavioral stress response predicts postoperative behavioral and clinical recovery of children undergoing surgery.

Conditions

  • Care, Postoperative
  • Pain, Postoperative
  • Surgical Procedures, Operative
  • Otorhinolaryngologic Surgical Procedures
  • Tonsillectomy
  • Adenoidectomy

Interventions

BEHAVIORAL

Preoperative Preparation Program (Child Life Specialist)

This group will receive the standard preoperative visit to the hospital with Child Life intervention

DRUG

Midazolam

0.5 mg/kg oral midazolam

BEHAVIORAL

Parental Presence during Induction of Anesthesia

One parent will be present during induction of anesthesia of the child. The parent will be accompanied out of the OR by a nurse once the induction is completed. These parents will have completed a parent preparation program.

OTHER

PPIA preparation program PLUS Midazolam premedication

Subjects in this group will receive both interventions 2 and 3.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH
  • University of California, Irvine

    lead OTHER

Principal Investigators

  • Zeev N Kain, MD, MBA · Yale University Department of Anesthesiology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00581139 on ClinicalTrials.gov