- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03755687
Art Therapy Pain Management Adolescents Pediatric ED
Effectiveness of Art Therapy Interventions for Adolescent Pain Management in the Pediatric Emergency Department
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.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- NewYork Presbyterian Morgan Stanley Children's Hospital Emergency Department
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Art Therapy Intervention
Standardized mixed media art therapy directives (e.g.
drawing/painting/collaging within a circle)
|
Standardized mixed media art directives.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in patient pain intensity: Verbal Numerical Rating Scale
Time Frame: 1 hour
|
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
Time Frame: 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.
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perception of pain and anxiety: Qualitative questions
Time Frame: 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?
|
1 hour
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Susanne M Bifano, MPS, MSED, NewYork-Presbyterian Morgan Stanley Children's Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AAAS3531
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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