ClinicalTrials.gg
RecruitingNCT05540106Updated Sep 17, 2026

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

An interventional study of Nature Coloring Packet and Geometric Shape Coloring Packet in Anxiety and Pain, sponsored by Stony Brook University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.

Primary conditionPainRegistry: Anxiety DisordersReclassifiedWhy we changed it
Registry
Anxiety Disorders — the first condition term the registry derived for this study.
ClinicalTrials.gg
Pain
Why
  1. The registry often attaches Anxiety Disorders to studies about something else, and this study's title and listed conditions do not name it.
  2. The study's listed conditions name Pain.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Stony Brook University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Aug 2023; still recruiting 3 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
168
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Anxiety
  • Pain

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03

In context

Pain Reclassified

10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.

This study's planned enrollment of 168 is above the median of 66 across 8,493 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

Stony Brook University is the lead sponsor of 197 studies on the registry; 36 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 11 (48%) have results posted.

Compared within Pain, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Triage Pain Score > 3
  • Age >18
  • Able to provide
  • 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
168 participants (estimated)

Study arms

  • Active comparator
    Blank Paper and Pencil

    Behavioral: Blank Paper and Pencil

  • Experimental
    Nature Coloring Packet

    Behavioral: Nature Coloring Packet

  • Experimental
    Geometric Shape Coloring Packet

    Behavioral: Geometric Shape Coloring Packet

  • Experimental
    Activity Book

    Behavioral: Activity Book

Interventions

  • BehavioralNature Coloring Packet

    Coloring packet containing nature scenes

  • BehavioralGeometric Shape Coloring Packet

    Coloring packet containing geometric shapes

  • BehavioralActivity Book

    Pages containing word searches, connect the dots, etc.

  • BehavioralBlank Paper and Pencil

    Blank sheets of paper and a pencil.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 8 hours

  2. Numerical Pain Score

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

    Time frame: 8 hours

Secondary outcomes

  1. 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

    Time frame: 8 hours

  2. Patient impression of activities

    Patient engagement (reported time packet used, recommendation for others to use)

    Time frame: 8 hours

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05540106
Responsible party
Lauren Marie Maloney (Clinical Assistant Professor of Emergency Medicine, Stony Brook University) — Principal investigator
First posted
Sep 14, 2022
Start date
Aug 1, 2023
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Sep 17, 2026

Study contacts

Lauren M Maloney, MD
Contact
lauren.maloney@stonybrookmedicine.edu
631-358-6652

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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