Art Therapy Pain Management Adolescents Pediatric ED

NCT03755687 | Completed

• 1 other identifier: AAAS3531
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Art Therapy; Pain Management; Pediatrics; Emergency Medicine

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Perception of pain and anxiety: Qualitative questions

  1 hour

Study Arms (1)

Art Therapy Intervention

EXPERIMENTAL

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

Other: Art Therapy Intervention

Interventions

Art Therapy Intervention OTHER

Standardized mixed media art directives.

Art Therapy Intervention

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• to 18 years of age, inclusive
• Painful condition with self-reported pain score of \>3/10

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• American Art Therapy Association: collaborator

Study Sites (1)

NewYork Presbyterian Morgan Stanley Children's Hospital Emergency Department

New York, New York, 10032, United States

Location

Related 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. doi: 10.1111/j.2044-8260.1992.tb00997.x.

  PMID: 1393159 BACKGROUND

MeSH Terms

Conditions

Pain; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Daniel S Tsze, MD, MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

• Susanne M Bifano, MPS, MSED

  NewYork-Presbyterian Morgan Stanley Children's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics in Emergency Medicine at CUMC

Model Details: Prospective observational pilot study

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: November 28, 2018
• Study Start: December 12, 2019
• Primary Completion: November 19, 2021
• Study Completion: November 19, 2021
• Last Updated: December 20, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)