Healthcare Provider Behavior and Children's Perioperative Distress

NCT01878747 | Completed DMC

• 1 other identifier: UCIANES02
• Study Type: interventional
• Target: 1,471
• Locations: 2 countries
• Sites: 6

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

1. 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. 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. 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

Conditions

Pain, Postoperative; Infant Behavior

Keywords

Pediatric; Pain; Postoperative; General Anesthesia; Anesthesia Recovery Period; Infant Behavior; Adolescent Behavior; Patient Satisfaction

Outcome Measures

Primary Outcomes (1)

• Child's anxiety in the operating room settings.

  m-YPAS (modified-Yale Preoperative Anxiety Scale)

  1 day

Secondary Outcomes (1)

• 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

Study Arms (2)

P-TIPS group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

Provider Tailored Intervention for Perioperative Stress BEHAVIORAL

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.

Also known as: P-TIPS

P-TIPS group

Eligibility Criteria

• Age: 2 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (6)

Children's Hospital Los Angeles

Los Angeles, California, 90027-6062, United States

Location

Stanford University

Menlo Park, California, 94025-3434, United States

Location

CHOC Children's Hospital

Orange, California, 92868, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 30602-7411, United States

Location

Boyd Graduate Studies Research Center

Athens, Georgia, 30602-7411, United States

Location

IWK Health Center

Halifax, Nova Scotia, B3K6R8, Canada

Location

Related Publications (1)

• 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.

  PMID: 26895152 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Infant Behavior; Pain; Adolescent Behavior; Patient Satisfaction

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Child Behavior; Behavior; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Zeev N. Kain, MD, MBA

  UC Irvine Medical Center, Dept. of Anesthesiology and Perioperative Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 8, 2013
• First Posted: June 17, 2013
• Study Start: June 1, 2011
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: February 25, 2019

Record last verified: 2019-02

Locations

US (5); CA (1)