AnxietyNCT05540106
Impact of Art Therapy on Self-Reported Pain and Anxiety Scores of Patients Waiting to Be Seen in the Emergency Department
A study testing Nature Coloring Packet, Geometric Shape Coloring Packet and Activity Book in people with Anxiety and Pain, run by Stony Brook University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Nature Coloring Packet, Geometric Shape Coloring Packet and Activity Book
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Concern for aggression risk, including active concern for suicidal or homicidal ideations
- Glasgow Coma Scale (GCS) <15
- triage acuity requiring critical care evaluation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stony Brook University Hospital
Stony Brook, New York, 11794
Lauren Maloney, MD
About this study
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.
- Being tested
- Nature Coloring Packet, Geometric Shape Coloring Packet, Activity Book, Blank Paper and Pencil
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nature Coloring PacketBehavioural
Coloring packet containing nature scenes
Geometric Shape Coloring PacketBehavioural
Coloring packet containing geometric shapes
Activity BookBehavioural
Pages containing word searches, connect the dots, etc.
Blank Paper and PencilBehavioural
Blank sheets of paper and a pencil.
| Study group | Role | What they receive |
|---|---|---|
| Blank Paper and Pencil | Active comparator | Not described Receives: Behavioral: Blank Paper and Pencil |
| Nature Coloring Packet | Experimental | Not described Receives: Behavioral: Nature Coloring Packet |
| Geometric Shape Coloring Packet | Experimental | Not described Receives: Behavioral: Geometric Shape Coloring Packet |
| Activity Book | Experimental | Not described Receives: Behavioral: Activity Book |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 8 hours
Numerical Pain Score
Change in self-reported numerical pain score following art therapy intervention (0-10, 10 = the worst pain)
Measured: 8 hours
Secondary outcomes (2)
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
Measured: 8 hours
Patient impression of activities
Patient engagement (reported time packet used, recommendation for others to use)
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start1 Aug 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauren Marie Maloney, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540106
- Sponsor's protocol ID
- 2022-00088
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2022
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Art Therapy on Self-Reported Pain and Anxiety Scores of Patients Waiting to Be Seen in the Emergency Department
- ClinicalTrials.gov ID
- NCT05540106
- Acronym / sponsor ID
- 2022-00088
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 14 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Triage Pain Score > 3
- Age >18
- Able to provide informed consent
- English-speaking
- without concern for aggressive behavior
Key exclusion criteria (3 listed)
- Concern for aggression risk, including active concern for suicidal or homicidal ideations
- Glasgow Coma Scale (GCS) <15
- triage acuity requiring critical care evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nature Coloring PacketColoring packet containing nature scenes | Behavioural | Nature Coloring Packet |
| Geometric Shape Coloring PacketColoring packet containing geometric shapes | Behavioural | Geometric Shape Coloring Packet |
| Activity BookPages containing word searches, connect the dots, etc. | Behavioural | Activity Book |
| Blank Paper and PencilBlank sheets of paper and a pencil. | Behavioural | Blank Paper and Pencil |
Primary outcome
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)
Numerical Pain Score
Time frame: 8 hours
Change in self-reported numerical pain score following art therapy intervention (0-10, 10 = the worst pain)
2 secondary outcomes
Color Selection
Time frame: 8 hours
Patient impression of activities
Time frame: 8 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nature Coloring Packet, Geometric Shape Coloring Packet and Activity Book in people with Anxiety and Pain, run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren M Maloney, MD (631-358-6652, lauren.maloney@stonybrookmedicine.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety and Depression Scale-Anxiety (HADS-A) Score (time frame: 8 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.