Impact of Art Therapy on Self-Reported Pain and Anxiety Scores of Patients Waiting to Be Seen in the Emergency Department

September 13, 2023 updated by: Lauren Marie Maloney, Stony Brook University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

168

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • Stony Brook, New York, United States, 11794
        • Recruiting
        • Stony Brook University Hospital
        • Contact:
          • Lauren Maloney, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Blank Paper and Pencil
Behavioral: Blank Paper and Pencil
Blank sheets of paper and a pencil.
Experimental: Nature Coloring Packet
Behavioral: Nature Coloring Packet
Coloring packet containing nature scenes
Experimental: Geometric Shape Coloring Packet
Behavioral: Geometric Shape Coloring Packet
Coloring packet containing geometric shapes
Experimental: Activity Book
Behavioral: Activity Book
Pages containing word searches, connect the dots, etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Anxiety and Depression Scale-Anxiety (HADS-A) Score
Time Frame: 8 hours
Change in self-reported Hospital Anxiety and Depression Scale-Anxiety (HADS-A) Score following art therapy intervention (0-21, 21 = most anxious)
8 hours
Numerical Pain Score
Time Frame: 8 hours
Change in self-reported numerical pain score following art therapy intervention (0-10, 10 = the worst pain)
8 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Color Selection
Time Frame: 8 hours
Correlation between Hospital Anxiety and Depression Scale-Anxiety (HADS-A) Score or pain score and colors selected by patient to use during art therapy
8 hours
Patient impression of activities
Time Frame: 8 hours
Patient engagement (reported time packet used, recommendation for others to use)
8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stony Brook University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

September 10, 2022

First Submitted That Met QC Criteria

September 10, 2022

First Posted (Actual)

September 14, 2022

Study Record Updates

Last Update Posted (Actual)

September 15, 2023

Last Update Submitted That Met QC Criteria

September 13, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-00088

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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