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Clinical Trials/NCT03755687
NCT03755687
Completed
Not Applicable

Effectiveness of Art Therapy Interventions for Adolescent Pain Management in the Pediatric Emergency Department

Columbia University1 site in 1 country50 target enrollmentDecember 12, 2019
ConditionsPain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
Columbia University
Enrollment
50
Locations
1
Primary Endpoint
Change in patient pain intensity: Verbal Numerical Rating Scale
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

This project is studying adolescents between the ages of 12 to 18 years that come to the emergency department and are in pain. We want to find out how well art therapy is able to decrease the pain they are experiencing. Art therapy will involve making art and working with an art therapist to find new ways of expressing thoughts and feelings through art making.

In adolescents presenting to the emergency department with a painful condition, our aims are as follows:

Aim #1: To determine the degree that art therapy intervention reduces pain and anxiety.

Aim #2: To determine the degree that art therapy reduces pain and anxiety 1 hour after the intervention.

Aim #3: To explore the qualitative experience of patients undergoing art therapy intervention.

Detailed Description

Pain is one of the most common reasons for patients to visit the emergency department (ED), and can be treated using both complementary and pharmacological strategies. However, children are often undertreated for pain which results in not only short term problems, but long term consequences such as trauma and stress-induced disorders; health care avoidance as adults; increased pain sensitivity; and decreased response to future analgesia. There have been variable efforts made to improve the ED management of pain in children, but adolescents are frequently overlooked. A review of the literature revealed that art therapy for pain management in adolescents is understudied. The majority of studies describe the effects of art therapy on the emotional well-being in surgical and oncology populations in adults and children. The studies that did evaluate the effectiveness of art therapy for pain management in children focused primarily on surgical and medical oncology populations with children aged 2-14 years. Of these studies, none evaluated adolescents in the ED, which is a high volume and high stress environment that confers a distinct experience for patients compared to other medical settings. Evaluation of art therapy interventions using quantitative self-report measures with strong validity in children and further delineation of the patient experience related to art therapy is necessary. Advanced evaluation of aforementioned interventions would expand the evidence base needed to describe effectiveness of these interventions and support greater implementation and dissemination. These are the gaps in knowledge that the investigators aim to fill with the proposed study.

Registry
clinicaltrials.gov
Start Date
December 12, 2019
End Date
November 19, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Daniel S Tsze, MD, MPH

Associate Professor of Pediatrics in Emergency Medicine at CUMC

Columbia University

Eligibility Criteria

Inclusion Criteria

  • 12 to 18 years of age, inclusive
  • Painful condition with self-reported pain score of \>3/10

Exclusion Criteria

  • Critical illness as per attending physician
  • Any neurological or developmental condition that precludes engagement in art therapy or ability to use a self-reported measure of pain
  • Chronic disease associated with pain (e.g. sickle cell disease, fibromyalgia)
  • Medical condition necessitating multiple painful procedures (e.g. malignancy, organ transplant)
  • Does not speak English

Outcomes

Primary Outcomes

Change in patient pain intensity: Verbal Numerical Rating Scale

Time Frame: 1 hour

Pain intensity measured using the Verbal Numerical Rating Scale. Minimum score (no pain) = 0, maximum score (most/worst pain) = 10.

Change in patient anxiety: Short Form STAI

Time Frame: 1 hour

Anxiety measured using the short form State-Trait Anxiety Inventory (STAI). Consists of six short statements (e.g. "I feel calm", "I am tense"). For each statement, subject selects a response on a 4-point Likert scale, ranging from 1=Not at all, to 4=Very much.

Secondary Outcomes

  • Perception of pain and anxiety: Qualitative questions(1 hour)

Study Sites (1)

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