Art Therapy Pain Management Adolescents Pediatric ED

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03755687
• Other study ID #: AAAS3531
• Status: Completed
• Phase: N/A
• Start date: December 12, 2019
• Est. completion date: November 19, 2021

Study information

• Verified date: December 2021
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 19, 2021
• Est. primary completion date: November 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• Art Therapy Intervention
Standardized mixed media art directives.

Locations

Country	Name	City	State
United States	NewYork Presbyterian Morgan Stanley Children's Hospital Emergency Department	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	American Art Therapy Association

Country where clinical trial is conducted

United States, 

References & Publications (1)

Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992 Sep;31(3):301-6. Erratum in: Br J Clin Psychol. 2020 Jun;59(2):276. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in patient pain intensity: Verbal Numerical Rating Scale	Pain intensity measured using the Verbal Numerical Rating Scale. Minimum score (no pain) = 0, maximum score (most/worst pain) = 10.	1 hour
Primary	Change in patient anxiety: Short Form STAI	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.	1 hour
Secondary	Perception of pain and anxiety: Qualitative questions	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?	1 hour

External Links

•   Article:The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI) with STAI inventory used in the research