About 4 million children undergo surgery in the US each year and up to 65% of these children experience significant anxiety and distress before surgery. Not only is high preoperative anxiety emotionally traumatic, but it also leads to postoperative adverse outcomes such as increased pain and analgesic requirements, delayed hospital discharge, and maladaptive behavioral changes. In a study completed at Yale, our group identified specific behaviors by health care providers and parents that can easily be incorporated into a busy practice environment and positively impact children's distress and coping behaviors prior to surgery. Based on these data we developed a Provider Tailored Intervention for Perioperative Stress (P-TIPS) that is aimed at reducing anxiety and distress in children prior to surgery by modifying adults'behavior. A pilot trial conducted at University of California Los Angeles and University of California Irvine successfully demonstrated the feasibility and initial efficacy of P-TIPS and examined dose-effectiveness. The proposed clustered randomized trial of four California children's hospitals, each with a total of approximately 20 anesthesia and nursing health care providers (HCP) will examine the effectiveness of P-TIPS in preventing high anxiety and improving the recovery process in children undergoing surgery. Objective measures of children's preoperative anxiety and postoperative recovery will be collected. The primary aim of the study is to determine if P-TIPS is more effective than standard care for preventing high preoperative anxiety among children undergoing anesthesia and surgery. Secondary aims of the study are to: 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;2. Determine if the use of P-TIPS results in higher satisfaction and lower anxiety scores in parents and 3. Determine if HCP in the P-TIPS group display more desired behaviors and less undesired behaviors as compared to the control group. We expect this project to be transformative in nature as in the past all treatment modalities for preoperative anxiety have focused on an individual child- parent dyad. In contrast, this intervention is aimed at health care providers who are likely to treat thousands of child-parent dyads in their career. Once tested for effectiveness P-TIPS will be implemented in hospitals across the country.

Public Health Relevance

The proposed study will examine the efficacy of modifying health care providers and parents'behavior in surgical settings. If we find that this intervention is effective in decreasing preoperative anxiety and improving the postoperative recovery in children undergoing surgery, then it can be incorporated into a treatment plan as the standard of care in the US. Preliminary discussions with the American Society of Anesthesiologists, the American Board of Anesthesiology and the Society of Pediatric Anesthesia have indicated the willingness of these organizations to include P-TIPS in residency, fellowship and CME programs.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project (R01)
Project #
5R01HD048935-07
Application #
8264965
Study Section
Behavioral Medicine, Interventions and Outcomes Study Section (BMIO)
Program Officer
Haverkos, Lynne
Project Start
2005-08-01
Project End
2016-05-31
Budget Start
2012-06-01
Budget End
2013-05-31
Support Year
7
Fiscal Year
2012
Total Cost
$603,341
Indirect Cost
$59,745
Name
University of California Irvine
Department
Anesthesiology
Type
Schools of Medicine
DUNS #
046705849
City
Irvine
State
CA
Country
United States
Zip Code
92697
Jenkins, Brooke N; Fortier, Michelle A; Kaplan, Sherrie H et al. (2014) Development of a short version of the modified Yale Preoperative Anxiety Scale. Anesth Analg 119:643-50
Martin, Sarah R; Chorney, Jill M; Cohen, Lindsey L et al. (2013) Sequential analysis of mothers' and fathers' reassurance and children's postoperative distress. J Pediatr Psychol 38:1121-9
Chorney, Jill Maclaren; Tan, Edwin T; Martin, Sarah R et al. (2012) Children's behavior in the postanesthesia care unit: the development of the Child Behavior Coding System-PACU (CBCS-P). J Pediatr Psychol 37:338-47
Martin, Sarah R; Chorney, Jill Maclaren; Tan, Edwin T et al. (2011) Changing healthcare providers' behavior during pediatric inductions with an empirically based intervention. Anesthesiology 115:18-27
Chorney, Jill MacLaren; Kain, Zeev N (2010) Family-centered pediatric perioperative care. Anesthesiology 112:751-5
Chorney, Jill MacLaren; Torrey, Carrie; Blount, Ronald et al. (2009) Healthcare provider and parent behavior and children's coping and distress at anesthesia induction. Anesthesiology 111:1290-6
Kain, Zeev N; MacLaren, Jill E; Herrmann, Leslie et al. (2009) Preoperative melatonin and its effects on induction and emergence in children undergoing anesthesia and surgery. Anesthesiology 111:44-9
Kain, Zeev N; Maclaren, Jill; Weinberg, Megan et al. (2009) How many parents should we let into the operating room? Paediatr Anaesth 19:244-9
Chorney, Jill MacLaren; Kain, Zeev N (2009) Behavioral analysis of children's response to induction of anesthesia. Anesth Analg 109:1434-40
MacLaren, Jill; Kain, Zeev N (2008) A comparison of preoperative anxiety in female patients with mothers of children undergoing surgery. Anesth Analg 106:810-3, table of contents

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