Impact of Art Therapy on Self-Reported Pain and Anxiety Scores of Patients Waiting to Be Seen in the Emergency Department
Primary Purpose
Anxiety, Pain
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nature Coloring Packet
Geometric Shape Coloring Packet
Activity Book
Blank Paper and Pencil
Sponsored by
About this trial
This is an interventional supportive care trial for Anxiety
Eligibility Criteria
Inclusion Criteria:
- Triage Pain Score > 3
- Age >18
- Able to provide informed consent
- English-speaking
- without concern for aggressive behavior
- Glasgow Coma Scale (GCS) of 15
- Hospital Anxiety and Depression Scale-Anxiety (HADS-A) Score > 6
Exclusion Criteria:
- Concern for aggression risk, including active concern for suicidal or homicidal ideations
- Glasgow Coma Scale (GCS) <15
- triage acuity requiring critical care evaluation
Sites / Locations
- Stony Brook University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Arm Label
Blank Paper and Pencil
Nature Coloring Packet
Geometric Shape Coloring Packet
Activity Book
Arm Description
Outcomes
Primary Outcome Measures
Hospital Anxiety and Depression Scale-Anxiety (HADS-A) Score
Change in self-reported Hospital Anxiety and Depression Scale-Anxiety (HADS-A) Score following art therapy intervention (0-21, 21 = most anxious)
Numerical Pain Score
Change in self-reported numerical pain score following art therapy intervention (0-10, 10 = the worst pain)
Secondary Outcome Measures
Color Selection
Correlation between Hospital Anxiety and Depression Scale-Anxiety (HADS-A) Score or pain score and colors selected by patient to use during art therapy
Patient impression of activities
Patient engagement (reported time packet used, recommendation for others to use)
Full Information
NCT ID
NCT05540106
First Posted
September 10, 2022
Last Updated
September 13, 2023
Sponsor
Stony Brook University
1. Study Identification
Unique Protocol Identification Number
NCT05540106
Brief Title
Impact of Art Therapy on Self-Reported Pain and Anxiety Scores of Patients Waiting to Be Seen in the Emergency Department
Official Title
Impact of Art Therapy on Self-Reported Pain and Anxiety Scores of Patients Waiting to Be Seen in the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this research is to assess the effects of engaging in coloring activities on patients' self-reported pain and anxiety scores while they wait to be seen by a physician in an emergency department (ED). The current literature on patient visits in the ED highlights the significance of anxiety, stress, and frustration in patient experiences, especially when accounting for long wait times before the physician-patient encounter. The study will address this common problem by looking at the potential impact of nature-themed or geometric shape coloring activities on the ED patient experience as it relates to self-reported anxiety and pain scores. Given that long wait times are increasingly being reported across the country, this study may offer a possible meaningful low-budget, low-resource intervention which could be offered to patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a randomized, four-armed prospective interventional study that will test the effect of nature-based coloring activities on patients' pain and anxiety scores during their ED visit. The study will consist of three intervention groups and one active control group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
168 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Blank Paper and Pencil
Arm Type
Active Comparator
Arm Title
Nature Coloring Packet
Arm Type
Experimental
Arm Title
Geometric Shape Coloring Packet
Arm Type
Experimental
Arm Title
Activity Book
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Nature Coloring Packet
Intervention Description
Coloring packet containing nature scenes
Intervention Type
Behavioral
Intervention Name(s)
Geometric Shape Coloring Packet
Intervention Description
Coloring packet containing geometric shapes
Intervention Type
Behavioral
Intervention Name(s)
Activity Book
Intervention Description
Pages containing word searches, connect the dots, etc.
Intervention Type
Behavioral
Intervention Name(s)
Blank Paper and Pencil
Intervention Description
Blank sheets of paper and a pencil.
Primary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale-Anxiety (HADS-A) Score
Description
Change in self-reported Hospital Anxiety and Depression Scale-Anxiety (HADS-A) Score following art therapy intervention (0-21, 21 = most anxious)
Time Frame
8 hours
Title
Numerical Pain Score
Description
Change in self-reported numerical pain score following art therapy intervention (0-10, 10 = the worst pain)
Time Frame
8 hours
Secondary Outcome Measure Information:
Title
Color Selection
Description
Correlation between Hospital Anxiety and Depression Scale-Anxiety (HADS-A) Score or pain score and colors selected by patient to use during art therapy
Time Frame
8 hours
Title
Patient impression of activities
Description
Patient engagement (reported time packet used, recommendation for others to use)
Time Frame
8 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Triage Pain Score > 3
Age >18
Able to provide informed consent
English-speaking
without concern for aggressive behavior
Glasgow Coma Scale (GCS) of 15
Hospital Anxiety and Depression Scale-Anxiety (HADS-A) Score > 6
Exclusion Criteria:
Concern for aggression risk, including active concern for suicidal or homicidal ideations
Glasgow Coma Scale (GCS) <15
triage acuity requiring critical care evaluation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren M Maloney, MD
Phone
631-358-6652
Email
lauren.maloney@stonybrookmedicine.edu
Facility Information:
Facility Name
Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Maloney, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of Art Therapy on Self-Reported Pain and Anxiety Scores of Patients Waiting to Be Seen in the Emergency Department
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