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

NCT03075059 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2021-05-03

No results posted yet for this study

Summary

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. 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. Assess if additional Child Life intervention offered pre-operatively to one group demonstrates differences in PRAP scores compared to control group

Conditions

  • Surgery

Interventions

BEHAVIORAL

Child Life

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.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Marleta Reynolds, M.D. · Ann & Robert H Lurie Children's Hospital of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-03
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03075059 on ClinicalTrials.gov