Healthcare Provider Behavior and Children's Perioperative Distress

Completed · Not applicable

Conditions studied: Pain, Postoperative, Infant Behavior

In brief

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 children undergoing surgery. Four hospitals and all Healthcare Providers (HCP) in it will be randomized to either a P-TIPS Group, who will receive the newly developed intervention, or a Control Group who will receive a 2-hour seminar on the management of preoperative anxiety and postoperative pain and otherwise will provide standard care. The aims of this study are to: PRIMARY AIM 1\. Determine if P-TIPS is more effective than standard care for preventing high preoperative anxiety among children undergoing anesthesia and surgery. The primary outcome will be observational anxiety in the operating room settings as measured by m-YPAS (modified-Yale Preoperative Anxiety Scale). SECONDARY AIMS 1. Examine the impact of P-TIPS on surgical recovery parameters such as postoperative pain, recovery room stay, nausea and vomiting, emergence delirium and maladaptive behavioral changes as measured by the PAED, and PHBQ 2. Determine if the use of P-TIPS results in higher satisfaction and lower anxiety scores in the parents.as measured by the STAIs, STAIt and Parent Satisfaction questionnaires 3. Determine if HCP in P-TIPS group display more desired behaviors and less undesired behaviors as compared to control group and whether these behaviors mediate the child and parent-level outcomes.These behaviors will be measured using the m-PCAMPIS

Key facts

Study ID: NCT01878747
Run by: University of California, Irvine
People needed: 1471
Starts: 2011-06-01
Expected to finish: 2016-06-01
Last updated by the study team: 2019-02-25

Who can join

Age: 2 and older, up to 14. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Children's Hospital Los Angeles — Los Angeles, California, United States
Stanford University — Menlo Park, California, United States
CHOC Children's Hospital — Orange, California, United States
Children's Hospital Colorado — Aurora, Colorado, United States
Boyd Graduate Studies Research Center — Athens, Georgia, United States
IWK Health Center — Halifax, Nova Scotia, Canada

Full record on ClinicalTrials.gov

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