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

NCT05540106 | Recruiting

• 1 other identifier: 2022-00088
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Pain

Outcome Measures

Primary Outcomes (2)

• 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)

  8 hours

• Numerical Pain Score

  Change in self-reported numerical pain score following art therapy intervention (0-10, 10 = the worst pain)

  8 hours

Secondary Outcomes (2)

• Color Selection

  8 hours

• Patient impression of activities

  8 hours

Study Arms (4)

Blank Paper and Pencil

ACTIVE COMPARATOR

Behavioral: Blank Paper and Pencil

Nature Coloring Packet

EXPERIMENTAL

Behavioral: Nature Coloring Packet

Geometric Shape Coloring Packet

EXPERIMENTAL

Behavioral: Geometric Shape Coloring Packet

Activity Book

EXPERIMENTAL

Behavioral: Activity Book

Interventions

Nature Coloring Packet BEHAVIORAL

Coloring packet containing nature scenes

Nature Coloring Packet

Geometric Shape Coloring Packet BEHAVIORAL

Coloring packet containing geometric shapes

Geometric Shape Coloring Packet

Activity Book BEHAVIORAL

Pages containing word searches, connect the dots, etc.

Activity Book

Blank Paper and Pencil BEHAVIORAL

Blank sheets of paper and a pencil.

Blank Paper and Pencil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Concern for aggression risk, including active concern for suicidal or homicidal ideations
• Glasgow Coma Scale (GCS) \<15
• triage acuity requiring critical care evaluation

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lauren M Maloney, MD

CONTACT

631-358-6652; lauren.maloney@stonybrookmedicine.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor of Emergency Medicine

Model Details: 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.

Study Record Dates

• First Submitted: September 10, 2022
• First Posted: September 14, 2022
• Study Start: August 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 3, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)