Art Therapy Pain Management Adolescents Pediatric ED

Sponsor

Columbia University (Other)

Overall Status

Completed

CT.gov ID

NCT03755687

Collaborator

American Art Therapy Association (Other)

Enrollment

Location

Arm

23.3

Actual Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Prospective observational pilot studyProspective 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 :

Dec 12, 2019

Actual Primary Completion Date :

Nov 19, 2021

Actual Study Completion Date :

Nov 19, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in patient pain intensity: Verbal Numerical Rating Scale [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 [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

Perception of pain and anxiety: Qualitative questions [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?

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Principal Investigator: Daniel S Tsze, MD, MPH, Columbia University
Study Director: Susanne M Bifano, MPS, MSED, NewYork-Presbyterian Morgan Stanley Children's Hospital