Status:
COMPLETED
Healthcare Provider Behavior and Children's Perioperative Distress
Lead Sponsor:
University of California, Irvine
Conditions:
Pain, Postoperative
Infant Behavior
Eligibility:
All Genders
2-14 years
Phase:
NA
Brief Summary
The goal of this randomized trial is to examine the effectiveness of a Provider Tailored Intervention for Perioperative Stress (P-TIPS) in preventing high anxiety and improving the recovery process in...
Detailed Description
The proposed clustered randomized trial of four children's hospitals: CHOC Children's (CHOC), Children's Hospital Los Angeles (CHLA), Lucile Packard Children's Hospital at Stanford, The Children's Hos...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Children:
- Children who are scheduled to undergo outpatient T\&A
- Children whose health status is American Society of Anesthesiologists (ASA) physical status I-III will be recruited for this study
- Only children who are in the normal range of development will be recruited for this study
- Parents: Parents of children who are enrolled in the study.
- Healthcare Provider:
- Anesthesia care providers in the four study hospitals
- Nurses who provide preoperative nursing care to children who are about to undergo surgery in the four study hospitals
- EXCLUSION CRITERIA
- Children:
- Patients with health status defined by ASA status IV-V
- Patients who are taking psychotropic medications that affect emotion modulation
- Patients who are taking medications such as erythromycin that interfere with the metabolism of midazolam
- Patients born before 36 weeks gestational age are considered premature and will not be included in this study
- Patients with a positive sleep study and patients who have any indication to be admitted postoperatively (e.g. positive sleep study)
- Patients with a positive sleep study indicating sleep apnea will also be excluded from this study.
- Parents:
- Parents who refuse to be part of the study
- Parents who don't speak English if the health care providers involved with that child-parent dyad don't speak the language that is spoken by the parent and child
- Healthcare Providers:
- Anesthesiologists who refuse to be part of the study
- Nurses who refuse to be part of the study
Exclusion
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
1471 Patients enrolled
Trial Details
Trial ID
NCT01878747
Start Date
June 1 2011
End Date
June 1 2016
Last Update
February 25 2019
Active Locations (6)
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1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027-6062
2
Stanford University
Menlo Park, California, United States, 94025-3434
3
CHOC Children's Hospital
Orange, California, United States, 92868
4
Children's Hospital Colorado
Aurora, Colorado, United States, 30602-7411