Clinical trial NCT03755687: Art Therapy Pain Management Adolescents Pediatric ED
Official title: Effectiveness of Art Therapy Interventions for Adolescent Pain Management in the Pediatric Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Art Therapy
Pain Management
Pediatrics
Emergency Medicine
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: American Art Therapy Association
First posted: 2018-11-28
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective observational pilot study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in patient pain intensity: Verbal Numerical Rating Scale
timeFrame: 1 hour
measure: Change in patient anxiety: Short Form STAI
timeFrame: 1 hour
Secondary outcomes:
measure: Perception of pain and anxiety: Qualitative questions
timeFrame: 1 hour
Other outcomes:
Locations:
city: New York
country: United States
facility: NewYork Presbyterian Morgan Stanley Children's Hospital Emergency Department
state: New York
Study officials:
affiliation: Columbia University
name: Daniel S Tsze, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: NewYork-Presbyterian Morgan Stanley Children's Hospital
name: Susanne M Bifano, MPS, MSED
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1111/j.2044-8260.1992.tb00997.x.