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Healthcare Provider Behavior and Children's Perioperative Distress

Primary Purpose

Pain, Postoperative, Infant Behavior

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Provider Tailored Intervention for Perioperative Stress
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Postoperative focused on measuring Pediatric, Pain, Postoperative, General Anesthesia, Anesthesia Recovery Period, Infant Behavior, Adolescent Behavior, Patient Satisfaction

Eligibility Criteria

2 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital Los Angeles
  • Stanford University
  • CHOC Children's Hospital
  • Children's Hospital Colorado
  • Boyd Graduate Studies Research Center
  • IWK Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

P-TIPS group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Child's anxiety in the operating room settings.
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.

Full Information

First Posted
February 8, 2013
Last Updated
February 21, 2019
Sponsor
University of California, Irvine
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1. Study Identification

Unique Protocol Identification Number
NCT01878747
Brief Title
Healthcare Provider Behavior and Children's Perioperative Distress
Official Title
Healthcare Provider Behavior and Children's Perioperative Distress
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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 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 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 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Infant Behavior
Keywords
Pediatric, Pain, Postoperative, General Anesthesia, Anesthesia Recovery Period, Infant Behavior, Adolescent Behavior, Patient Satisfaction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1471 (Actual)

8. Arms, Groups, and Interventions

Arm Title
P-TIPS group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Provider Tailored Intervention for Perioperative Stress
Other Intervention Name(s)
P-TIPS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Child's anxiety in the operating room settings.
Description
m-YPAS (modified-Yale Preoperative Anxiety Scale)
Time Frame
1 day
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeev N. Kain, MD, MBA
Organizational Affiliation
UC Irvine Medical Center, Dept. of Anesthesiology and Perioperative Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027-6062
Country
United States
Facility Name
Stanford University
City
Menlo Park
State/Province
California
ZIP/Postal Code
94025-3434
Country
United States
Facility Name
CHOC Children's Hospital
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
30602-7411
Country
United States
Facility Name
Boyd Graduate Studies Research Center
City
Athens
State/Province
Georgia
ZIP/Postal Code
30602-7411
Country
United States
Facility Name
IWK Health Center
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K6R8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
26895152
Citation
Stevenson RS, Rosales A, Fortier MA, Campos B, Golianu B, Zuk J, Gold J, Kain ZN. The Role of Ethnicity and Acculturation in Preoperative Distress in Parents of Children Undergoing Surgery. J Immigr Minor Health. 2017 Jun;19(3):738-744. doi: 10.1007/s10903-016-0357-7.
Results Reference
derived

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Healthcare Provider Behavior and Children's Perioperative Distress

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