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Completed

NCT Number: NCT03755687

Art Therapy Pain Management Adolescents Pediatric ED

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.

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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NewYork Presbyterian Morgan Stanley Children's Hospital Emergency Department

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Art Therapy Intervention

Other

Standardized mixed media art directives.

Primary outcomes

  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 outcomes

  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?

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • American Art Therapy Association

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 28, 2018
Registry last updated
Dec 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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