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Art Therapy Pain Management Adolescents Pediatric ED

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03755687
Recruitment Status : Suspended (Paused until further notice due to COVID-19 restrictions)
First Posted : November 28, 2018
Last Update Posted : April 28, 2020
Sponsor:
Collaborator:
American Art Therapy Association
Information provided by (Responsible Party):
Daniel S Tsze, MD, MPH, Columbia University

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.


Condition or disease Intervention/treatment Phase
Pain Other: Art Therapy Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: A prospective observational pilot study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Art Therapy Interventions for Adolescent Pain Management in the Pediatric Emergency Department
Actual Study Start Date : December 12, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Art Therapy Intervention
Standardized mixed media art therapy directives (e.g. drawing/painting/collaging within a circle)
Other: Art Therapy Intervention
Standardized mixed media art directives.




Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Perception of pain and anxiety: Qualitative questions [ Time Frame: 1 hour ]
    Qualitative questions (3): 1. How would you describe this art therapy session? 2. What were some sensations you experienced in your body while you were engaged in the session? 3. Is there anything else you would like to say about what you are experiencing in your body and the art therapy session?



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03755687


Locations
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United States, New York
NewYork Presbyterian Morgan Stanley Children's Hospital Emergency Department
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
American Art Therapy Association
Investigators
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Principal Investigator: Daniel S Tsze, MD, MPH Columbia University
Study Director: Susanne M Bifano, MPS, MSED NewYork-Presbyterian Morgan Stanley Children's Hospital
Additional Information:
Publications:
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Responsible Party: Daniel S Tsze, MD, MPH, Associate Professor of Pediatrics in Emergency Medicine at CUMC, Columbia University
ClinicalTrials.gov Identifier: NCT03755687    
Other Study ID Numbers: AAAS3531
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daniel S Tsze, MD, MPH, Columbia University:
Art Therapy
Pain Management
Pediatrics
Emergency Medicine