Child Life Intervention to Decrease Anxiety in Patients and Caregivers for Outpatient Surgical Intervention

NCT03075059 | Completed

• 1 other identifier: 2016-161
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Determine preoperative and postoperative levels of anxiety for pediatric patients ages 6-17 related to outpatient surgical intervention using the validated Psychosocial Risk Assessment in Pediatrics (PRAP) assessment tool, the State-Trait Anxiety Inventory for Adults(STAI-AD), and the State-Trait Anxiety Inventory for Children (STAI-CH)
2. 2.Determine preoperative and postoperative levels of anxiety for parent/guardian of pediatric patients ages 6 - 17 related to outpatient surgical intervention using the validate PsychosocialRisk Assessment in Pediatrics (PRAP) assessment tool and the State-Trait Anxiety Inventory for Adults (STAI-AD).
3. 3.Assess if additional Child Life intervention offered pre-operatively to one group demonstrates differences in PRAP scores compared to control group

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

• Patient and Parent/Guardian State and Trait Anxiety

  Patient and Parent/Guardian State and Trait Anxiety is measured using the the State-Trait Anxiety Inventory for Adults (STAI-AD), and the State-Trait Anxiety Inventory for Children (STAI-CH) for children between the ages of 6 and 14

  6 months

Secondary Outcomes (1)

• Patient and Parent/Guardian PRAP scores

  6 months

Study Arms (2)

Intervention

EXPERIMENTAL

For patients randomized to the intervention group, the Child Life specialist will reach out via telephone to offer support and expertise in helping prepare their child and themselves for outpatient surgery to help decrease anxiety and increase coping. Concepts covered will include: developmentally appropriate language for explaining surgery and related procedures, potential coping skills to ease separation for caregivers and pediatric patients. Additionally, written materials (attached) covering the same information will be sent via mail or email covering the same information discussed in the phone conversation to serve as a refresher and resource before the day of surgery. On the day of surgery, the patient will receive standard of care (SOC) Child Life Services available to all patients.

Behavioral: Child Life

Control

NO INTERVENTION

Patients randomized to the control group will not receive the preoperative phone call or written materials and will only receive SOC Child Life services on the day of surgery.

Interventions

Child Life BEHAVIORAL

For patients randomized to the intervention group, the Child Life specialist will reach out via telephone to offer support and expertise in helping prepare their child and themselves for outpatient surgery to help decrease anxiety and increase coping. Concepts covered will include: developmentally appropriate language for explaining surgery and related procedures, potential coping skills to ease separation for caregivers and pediatric patients. Additionally, written materials (attached) covering the same information will be sent via mail or email covering the same information discussed in the phone conversation to serve as a refresher and resource before the day of surgery. On the day of surgery, the patient will receive standard of care (SOC) Child Life Services available to all patients.

Intervention

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Participants will be patients ages 6 - 17 and their families/caregivers that are scheduled for outpatient surgical intervention in the division of pediatric surgery of Ann and Robert H. Lurie Children's Hospital of Chicago. Patients receiving low acute, lower risk procedures will be enrolled

You may not qualify if:

• Patients who may turn 18 during the course of the study will not be eligible for enrollment and will be excluded.

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead

Study Sites (1)

Ann & Robert H. Lurie Children's Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

Allied Health Personnel

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Marleta Reynolds, M.D.

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 9, 2017
• Study Start: February 3, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)