Art Therapy Pain Management Adolescents Pediatric ED

NCT ID: NCT03755687

Last Updated: 2021-12-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-12
• Study Completion Date: 2021-11-19

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.

Conditions

Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Art Therapy Intervention

Standardized mixed media art therapy directives (e.g. drawing/painting/collaging within a circle)

Group Type: EXPERIMENTAL

Art Therapy Intervention

Intervention Type: OTHER

Standardized mixed media art directives.

Interventions

Art Therapy Intervention

Standardized mixed media art directives.

Intervention Type: OTHER

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Art Therapy Association

UNKNOWN

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Daniel S Tsze, MD, MPH

Associate Professor of Pediatrics in Emergency Medicine at CUMC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel S Tsze, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Susanne M Bifano, MPS, MSED

Role: STUDY_DIRECTOR

NewYork-Presbyterian Morgan Stanley Children's Hospital

Locations

NewYork Presbyterian Morgan Stanley Children's Hospital Emergency Department

New York, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 1393159 (View on PubMed)

Other Identifiers

AAAS3531

Identifier Type: -

Identifier Source: org_study_id