Healthcare Provider Behavior and Children's Perioperative Distress

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of California, Irvine
Sponsor:
Information provided by (Responsible Party):
Zeev Kain, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01878747
First received: February 8, 2013
Last updated: June 12, 2013
Last verified: June 2013
  Purpose

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

Condition Intervention
Pain, Postoperative
Infant Behavior
Behavioral: Provider Tailored Intervention for Perioperative Stress

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Healthcare Provider Behavior and Children's Perioperative Distress

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Child's anxiety in the operating room settings. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    m-YPAS (modified-Yale Preoperative Anxiety Scale)


Secondary Outcome Measures:
  • Impact of the intervention on the child's recovery parameters including emergence delirium, systolic pressure, diastolic pressure, heart rate recordings, and analgesic consumption. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 1920
Study Start Date: June 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: P-TIPS group
Provider Tailored Intervention for Perioperative Stress (P-TIPS) aims at reducing preoperative anxiety in children via modifying adults' behavior.P-TIPS program is developed from the proximal-distal theory that suggested that in acute procedural settings specific adult behaviors directly affect children's distress and coping behaviors.
Behavioral: Provider Tailored Intervention for Perioperative Stress
Provider Tailored Intervention for Perioperative Stress (P-TIPS) is developed based on the proximal-distal theory that suggested that in acute procedural settings specific adult behaviors directly affect children's distress and coping behaviors. P-TIPS aims at reducing preoperative anxiety in children via modifying adults' behavior.
Other Name: P-TIPS
No Intervention: Control Group
Subjects in this group will not be trained with the P-TIPS method. They will receive a 2-hour seminar on the management of preoperative anxiety and postoperative pain and otherwise will provide standard care to patients.

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 Hospital, Denver. At each hospital approximately 20 anesthesia and nursing health care providers (HCP) will examine the effectiveness of a Provider Tailored Intervention for Perioperative Stress (P-TIPS) aimed at preventing high anxiety and improving the recovery process in children undergoing surgery via modifying adults' behavior. Each hospital and all 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. Objective measures of children's preoperative anxiety and postoperative recovery, as well as adherence measures of HCP will be collected prior and during the experimental period.

HCP in the Intervention group will learn that the use of behaviors as such distraction and medical reinterpretation directs the child's attention towards more enjoyable topics or reframes the procedure into something less threatening, which in turn diverts the child's attention away from their own distress or fear. Conversely, although HCPs often use reassurance and empathy to help soothe children, the education that HCPs receive from P-TIPS will explain that these emotion-focused comments seem to direct children's attention to their own distress and frightening aspects of the medical procedure. HCPs will also learn the intricacies of implementing these strategies and ways to adjust their behavior to effectively keep children engaged in coping related behaviors.

Child's anxiety m-YPAS during induction is assessed at two points, a) entering the operating room and b) introduction of the anesthesia mask to the child. Once in the OR, the child's blood pressure and heart rate is also assessed. A total of 10 child-parent dyad interactions per HCP are collected for the baseline assessment phase. HCP behavior during induction is also videotaped by research assistants and coded later using the P-CAMPIS measure. Also, parents and children answer baseline questionnaires aimed at capturing demographics, anxiety, health beliefs. Postoperative analgesic consumption, behavioral and recovery measures are also collected.

  Eligibility

Ages Eligible for Study:   2 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01878747

Contacts
Contact: Sulay H. Gomez, B.A. 714-480-0039 sulayg@uci.edu
Contact: Eva Maurer, B.S. 714-480-0039 emaurer@uci.edu

Locations
United States, California
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027-6062
Contact: Jeffrey Gold, PhD         
Sub-Investigator: Jeffrey I Gold, PhD         
Stanford University Recruiting
Menlo Park, California, United States, 94025-3434
Contact: Brenda Golianu, MD         
Sub-Investigator: Brenda Golianu, MD         
CHOC Children's Hospital Recruiting
Orange, California, United States, 92868
Contact: Sulay H. Gomez, B.A.    714-480-0039    sulayg@uci.edu   
Contact: Eva Maurer, B.S.    714-480-0039    emaurer@uci.edu   
Principal Investigator: Zeev N. Kain, MD         
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 30602-7411
Contact: Jeannie Zuk, PhD         
Sub-Investigator: Jeannie Zuk, PhD         
United States, Georgia
Boyd Graduate Studies Research Center Recruiting
Athens, Georgia, United States, 30602-7411
Contact: Ronald L. Blount, PhD         
Sub-Investigator: Ronald L. Blount, PhD         
Canada, Nova Scotia
IWK Health Center Recruiting
Halifax, Nova Scotia, Canada, B3K6R8
Contact: Jill E. Chorney, PhD         
Sub-Investigator: Jill E. Chorney, PhD         
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Zeev N. Kain, MD, MBA UC Irvine Medical Center, Dept. of Anesthesiology and Perioperative Care
  More Information

No publications provided

Responsible Party: Zeev Kain, Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01878747     History of Changes
Other Study ID Numbers: UCIANES02
Study First Received: February 8, 2013
Last Updated: June 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Pediatric
Pain
Postoperative
General Anesthesia
Anesthesia Recovery Period
Infant Behavior
Adolescent Behavior
Patient Satisfaction

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014