Healthcare Provider Behavior and Children's Perioperative Distress

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

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Infant Behavior
• Intervention / Treatment: Behavioral: Provider Tailored Intervention for Perioperative Stress

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.

• Study Type: Interventional
• Enrollment (Actual): 1471
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K6R8
      • IWK Health Center
• United States
  • California
    • Los Angeles, California, United States, 90027-6062
      • Children's Hospital Los Angeles
    • Menlo Park, California, United States, 94025-3434
      • Stanford University
    • Orange, California, United States, 92868
      • CHOC Children's Hospital
  • Colorado
    • Aurora, Colorado, United States, 30602-7411
      • Children's Hospital Colorado
  • Georgia
    • Athens, Georgia, United States, 30602-7411
      • Boyd Graduate Studies Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child's anxiety in the operating room settings.	m-YPAS (modified-Yale Preoperative Anxiety Scale)	1 day

Secondary Outcome Measures

Outcome Measure	Time Frame
Impact of the intervention on the child's recovery parameters including emergence delirium, systolic pressure, diastolic pressure, heart rate recordings, and analgesic consumption.	2 weeks

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Investigators: Principal Investigator: Zeev N. Kain, MD, MBA, UC Irvine Medical Center, Dept. of Anesthesiology and Perioperative Care

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: February 8, 2013
• First Submitted That Met QC Criteria: June 12, 2013
• First Posted (Estimate): June 17, 2013

Study Record Updates

• Last Update Posted (Actual): February 25, 2019
• Last Update Submitted That Met QC Criteria: February 21, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Pain; Pediatric; Postoperative; Adolescent Behavior; General Anesthesia; Patient Satisfaction; Anesthesia Recovery Period; Infant Behavior
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: UCIANES02