Healthcare Provider Behavior and Children's Perioperative Distress



Status:Completed
Conditions:Post-Surgical Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:2 - 14
Updated:2/27/2019
Start Date:June 2011
End Date:June 2016

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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

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.

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
We found this trial at
6
sites
4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Halifax, Nova Scotia
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Menlo Park, California 94025
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Orange, California 92868
Principal Investigator: Zeev N. Kain, MD
Phone: 714-480-0039
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