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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05540106
Other study ID # 2022-00088
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2023
Est. completion date December 1, 2025

Study information

Verified date September 2023
Source Stony Brook University
Contact Lauren M Maloney, MD
Phone 631-358-6652
Email lauren.maloney@stonybrookmedicine.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 168
Est. completion date December 1, 2025
Est. primary completion date December 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Nature Coloring Packet
Coloring packet containing nature scenes
Geometric Shape Coloring Packet
Coloring packet containing geometric shapes
Activity Book
Pages containing word searches, connect the dots, etc.
Blank Paper and Pencil
Blank sheets of paper and a pencil.

Locations

Country Name City State
United States Stony Brook University Hospital Stony Brook New York

Sponsors (1)

Lead Sponsor Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Numerical Pain Score Change in self-reported numerical pain score following art therapy intervention (0-10, 10 = the worst pain) 8 hours
Secondary 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 8 hours
Secondary Patient impression of activities Patient engagement (reported time packet used, recommendation for others to use) 8 hours
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