PainNCT03755687
Art Therapy Pain Management Adolescents Pediatric ED
A study testing Art Therapy Intervention in people with Pain, run by Columbia University at 1 site in United States.
Trial summary
This project is studying adolescents between the ages of 12 to 18 years that come to the emergency department and are in pain. We want to find out how well art therapy is able to decrease the pain they are experiencing. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Art Therapy Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2019to 19 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 12 to 18 years of age, inclusive
- Painful condition with self-reported pain score of >3/10
Who cannot join
- Critical illness as per attending physician
- Any neurological or developmental condition that precludes engagement in art therapy or ability to use a self-reported measure of pain
- Chronic disease associated with pain (e.g. sickle cell disease, fibromyalgia)
- Medical condition necessitating multiple painful procedures (e.g. malignancy, organ transplant)
- Does not speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
NewYork Presbyterian Morgan Stanley Children's Hospital Emergency Department
New York, New York, 10032
About this study
Official title: Effectiveness of Art Therapy Interventions for Adolescent Pain Management in the Pediatric Emergency Department
This project is studying adolescents between the ages of 12 to 18 years that come to the emergency department and are in pain. We want to find out how well art therapy is able to decrease the pain they are experiencing. Art therapy will involve making art and working with an art therapist to find new ways of expressing thoughts and feelings through art making.
In adolescents presenting to the emergency department with a painful condition, our aims are as follows:
Read more
Aim #1: To determine the degree that art therapy intervention reduces pain and anxiety.
Aim #2: To determine the degree that art therapy reduces pain and anxiety 1 hour after the intervention.
Aim #3: To explore the qualitative experience of patients undergoing art therapy intervention.
Read the detailed description
Pain is one of the most common reasons for patients to visit the emergency department (ED), and can be treated using both complementary and pharmacological strategies. However, children are often undertreated for pain which results in not only short term problems, but long term consequences such as trauma and stress-induced disorders; health care avoidance as adults; increased pain sensitivity; and decreased response to future analgesia. There have been variable efforts made to improve the ED management of pain in children, but adolescents are frequently overlooked. A review of the literature revealed that art therapy for pain management in adolescents is understudied. The majority of studies describe the effects of art therapy on the emotional well-being in surgical and oncology populations in adults and children. The studies that did evaluate the effectiveness of art therapy for pain management in children focused primarily on surgical and medical oncology populations with children aged 2-14 years. Of these studies, none evaluated adolescents in the ED, which is a high volume and high stress environment that confers a distinct experience for patients compared to other medical settings. Evaluation of art therapy interventions using quantitative self-report measures with strong validity in children and further delineation of the patient experience related to art therapy is necessary. Advanced evaluation of aforementioned interventions would expand the evidence base needed to describe effectiveness of these interventions and support greater implementation and dissemination. These are the gaps in knowledge that the investigators aim to fill with the proposed study.
- Conditions
- Pain
- Being tested
- Art Therapy Intervention
- Keywords
- Art Therapy, Pain Management, Pediatrics, Emergency Medicine
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art Therapy InterventionOther
Standardized mixed media art directives.
| Study group | Role | What they receive |
|---|---|---|
| Art Therapy Intervention | Experimental | Standardized mixed media art therapy directives (e.g. drawing/painting/collaging within a circle) Receives: Other: Art Therapy Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient pain intensity: Verbal Numerical Rating Scale
Pain intensity measured using the Verbal Numerical Rating Scale. Minimum score (no pain) = 0, maximum score (most/worst pain) = 10.
Measured: 1 hour
Change in patient anxiety: Short Form STAI
Anxiety measured using the short form State-Trait Anxiety Inventory (STAI). Consists of six short statements (e.g. "I feel calm", "I am tense"). For each statement, subject selects a response on a 4-point Likert scale, ranging from 1=Not at all, to 4=Very much.
Measured: 1 hour
Secondary outcomes (1)
Perception of pain and anxiety: Qualitative questions
Qualitative questions (3): 1. How would you describe this art therapy session? 2. What were some sensations you experienced in your body while you were engaged in the session? 3. Is there anything else you would like to say about what you are experiencing in your body and the art therapy session?
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start12 Dec 2019
- Primary completion19 Nov 2021
- Study completion19 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective observational pilot study
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- American Art Therapy Association
- Responsible party
- Principal investigator, Daniel S Tsze, MD, MPH, Columbia University
- Investigators
- Daniel S Tsze, MD, MPH, Principal investigator, Columbia UniversitySusanne M Bifano, MPS, MSED, Study director, NewYork-Presbyterian Morgan Stanley Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03755687
- Sponsor's protocol ID
- AAAS3531
- Status last verified
- Dec 2021
- First submitted
- 26 Nov 2018
- Last updated
- 20 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992 Sep;31(3):301-6. doi: 10.1111/j.2044-8260.1992.tb00997.x.
PubMed 1393159
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Art Therapy Interventions for Adolescent Pain Management in the Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT03755687
- Acronym / sponsor ID
- AAAS3531
- Conditions
- Pain
- Keywords
- Art Therapy, Pain Management, Pediatrics, Emergency Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- American Art Therapy Association
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- 19 Nov 2021 (actual)
- Study completion
- 19 Nov 2021 (actual)
- First posted
- 28 Nov 2018 (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.
This project is studying adolescents between the ages of 12 to 18 years that come to the emergency department and are in pain. We want to find out how well art therapy is able to decrease the pain they are experiencing. Art therapy will involve making art and working with an art therapist to find new ways of expressing thoughts and feelings through art making.
In adolescents presenting to the emergency department with a painful condition, our aims are as follows:
Aim #1: To determine the degree that art therapy intervention reduces pain and anxiety.
Aim #2: To determine the degree that art therapy reduces pain and anxiety 1 hour after the intervention.
Aim #3: To explore the qualitative experience of patients undergoing art therapy intervention.
Detailed description
Pain is one of the most common reasons for patients to visit the emergency department (ED), and can be treated using both complementary and pharmacological strategies. However, children are often undertreated for pain which results in not only short term problems, but long term consequences such as trauma and stress-induced disorders; health care avoidance as adults; increased pain sensitivity; and decreased response to future analgesia. There have been variable efforts made to improve the ED management of pain in children, but adolescents are frequently overlooked. A review of the literature revealed that art therapy for pain management in adolescents is understudied. The majority of studies describe the effects of art therapy on the emotional well-being in surgical and oncology populations in adults and children. The studies that did evaluate the effectiveness of art therapy for pain management in children focused primarily on surgical and medical oncology populations with children aged 2-14 years. Of these studies, none evaluated adolescents in the ED, which is a high volume and high stress environment that confers a distinct experience for patients compared to other medical settings. Evaluation of art therapy interventions using quantitative self-report measures with strong validity in children and further delineation of the patient experience related to art therapy is necessary. Advanced evaluation of aforementioned interventions would expand the evidence base needed to describe effectiveness of these interventions and support greater implementation and dissemination. These are the gaps in knowledge that the investigators aim to fill with the proposed study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective observational pilot study
| Arm | Type | Receives |
|---|---|---|
| Art Therapy Intervention | Experimental | Other: Art Therapy InterventionStandardized mixed media art therapy directives (e.g. drawing/painting/collaging within a circle) |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 12 to 18 years of age, inclusive
- Painful condition with self-reported pain score of >3/10
Key exclusion criteria (5 listed)
- Critical illness as per attending physician
- Any neurological or developmental condition that precludes engagement in art therapy or ability to use a self-reported measure of pain
- Chronic disease associated with pain (e.g. sickle cell disease, fibromyalgia)
- Medical condition necessitating multiple painful procedures (e.g. malignancy, organ transplant)
- Does not speak English
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 |
|---|---|---|
| Art Therapy InterventionStandardized mixed media art directives. | Other | Art Therapy Intervention |
Primary outcome
Change in patient pain intensity: Verbal Numerical Rating Scale
Time frame: 1 hour
Pain intensity measured using the Verbal Numerical Rating Scale. Minimum score (no pain) = 0, maximum score (most/worst pain) = 10.
Change in patient anxiety: Short Form STAI
Time frame: 1 hour
Anxiety measured using the short form State-Trait Anxiety Inventory (STAI). Consists of six short statements (e.g. "I feel calm", "I am tense"). For each statement, subject selects a response on a 4-point Likert scale, ranging from 1=Not at all, to 4=Very much.
1 secondary outcome
Perception of pain and anxiety: Qualitative questions
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2021.
- Background: PubMed 1393159Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992 Sep;31(3):301-6. doi: 10.1111/j.2044-8260.1992.tb00997.x.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Daniel S Tsze, MD, MPH principal investigator
Columbia University
Susanne M Bifano, MPS, MSED study director
NewYork-Presbyterian Morgan Stanley Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Art Therapy Intervention in people with Pain, run by Columbia 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 20 Dec 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient pain intensity: Verbal Numerical Rating Scale (time frame: 1 hour). 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?
On the ClinicalTrials.gov record for NCT03755687, which also lists 1 linked publication.
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 20 Dec 2021.