Emotional DistressNCT06924268
Impact of a Single Art Therapy Session on Mood and Symptom Burden in Palliative Care
An observational study of Emotional Distress and Pain, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
The goal of this observational study is to explore whether a single art therapy session can improve mood and reduce symptom burden in adult palliative care patients at a Canadian inpatient unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emotional Distress, Pain, Anxiety
- What is being tested?
- Single Art Therapy Session
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2025to 1 Aug 2026
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Palliative Care In-Patients at the VG, 7A Palliative Care Unit
Who may be able to join
- admitted to the PCU
- have the ability to communicate
- complete self-assessments with or without facilitator assistance
- possess the ability to engage in a 30-60 minute art therapy session
Who cannot join
- Patients will be excluded if they are under 18 years of age
- within 48hrs of admission or discharge
- experiencing severe cognitive impairment, uncontrolled symptoms, or delirium.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluating the Impact of a Single Art Therapy Session on Mood and Symptom Burden in Palliative Care Patients
The goal of this observational study is to explore whether a single art therapy session can improve mood and reduce symptom burden in adult palliative care patients at a Canadian inpatient unit. The main questions it aims to answer are:
- Does a single art therapy session reduce overall symptom burden, as measured by the Edmonton Symptom Assessment System (ESAS)?
- Does a single art therapy session improve mood, as measured by the Positive and Negative Affect Schedule (PANAS)?
Participants will:
- Complete two short questionnaires (ESAS and PANAS) before and after the session
- Participate in a 30-60 minute individual art therapy session
Read the detailed description
This is a single-centre, prospective, observational pre-post study conducted at the QEII Health Sciences Centre, VG, 7A Palliative Care Unit. The aim is to evaluate whether a one-time, individualized art therapy session can positively impact emotional well-being and symptom distress in adults receiving inpatient palliative care.
Participants will be approached by the charge nurse and invited to participate if they meet the eligibility criteria. Following informed consent, participants will complete two validated self-report tools: the Edmonton Symptom Assessment System (ESAS) and the Positive and Negative Affect Schedule (PANAS). These assessments will be administered immediately before and again immediately after a 30-60 minute art therapy session, which will include open-ended creative engagement using simple materials such as watercolor and pastels.
The Study Objectives are:
- To determine whether participation in a structured art therapy session improves mood and symptom burden in palliative care patients
- Examine whether engagement in coloring activities influences emotional well-being as measured by the Positive and Negative Affect Schedule (PANAS) and symptom burden as measured by the Modified Edmonton Symptom Assessment System (ESAS).
- Is there a difference in as-needed (PRN) opioid, benzodiazepine, and Z drug use in the 48 hours before and after the session
- Examine whether specific patient characteristics, such as primary diagnosis or time from admission to intervention, impact the observed effects.
All data will be de-identified and analyzed descriptively and inferentially to assess trends in mood and symptom change following the intervention. This study does not involve randomization or a control group. It is designed to inform future research and program development in supportive care interventions within palliative settings.
- Conditions
- Emotional Distress, Pain, Anxiety
- Being tested
- Single Art Therapy Session
- Keywords
- Palliative, End of life, art therapy, quality of life
- Medical subject headings
- Pain, Anxiety Disorders, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Art Therapy SessionBehavioural
Also called Visual arts therapy, Expressive arts
Each participant will engage in a 30-60 minute structured art therapy session using pre-drawn coloring sheets featuring themes such as mandalas, nature scenes, and inspirational designs. A variety of coloring tools will be provided, including crayons, colored pencils, markers, gel pens, and watercolor paints. Sessions will be facilitated by the primary investigator, who will provide non-directive prompts and engage in casual conversation to foster comfort and engagement.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Positive and Negative Affect Scores Measured by PANAS Before and After Art Therapy
The Positive and Negative Affect Schedule (PANAS) will be administered immediately before and immediately after a single art therapy session. PANAS is a self-reported 20-item scale measuring two mood domains: positive affect (10 items) and negative affect (10 items). Each item is rated on a scale from 1 (very slightly or not at all) to 5 (extremely), with subscale scores ranging from 10 to 50. Higher positive affect scores indicate more positive mood; higher negative affect scores indicate more distress.
Measured: Immediately before and immediately after the art therapy session
Change in Symptom Burden Measured by Modified ESAS Before and After Art Therapy
The Edmonton Symptom Assessment System (ESAS) will be used to assess physical and emotional symptom burden immediately before and immediately after the art therapy session. ESAS consists of 9 core symptoms (e.g., pain, fatigue, nausea, anxiety, depression) each rated on a numeric scale from 0 (none) to 10 (worst possible severity). A total symptom score is calculated as the sum of all items, with higher scores indicating greater symptom burden. We will be using a modified version that does not include nausea, drowsiness, loss of appetite and dyspnea. The symptom "sadness" will be added to our assessment.
Measured: Immediately before and immediately after the art therapy session
Secondary outcomes (2)
Changes in PRN Opioid Use in the 48 Hours Before and After Art Therapy
The total dosage (mg), number of doses, medication type, and route of administration of PRN opioid medications (e.g., hydromorphone, morphine) will be extracted from the medical chart for each participant for the 48 hours before and the 48 hours after the art therapy session. Data will be converted to oral morphine equivalents as applicable. Data will be analyzed to assess changes in frequency or total daily dose following the intervention.
Measured: 48 hours before and 48 hours after the art therapy session
Changes in PRN Benzodiazepine and Z-Drug Use in the 48 Hours Before and After Art Therapy
The total dosage (mg), number of doses, medication type, and route of administration of PRN benzodiazepines (e.g., lorazepam) and Z-drugs (e.g., zopiclone) will be recorded from participant medical charts for the 48 hours before and after the art therapy session. Data will be analyzed to assess changes in frequency or total daily dose following the intervention.
Measured: 48 hours before and 48 hours after the art therapy session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start1 Jun 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional DistressStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Dalhousie University
- Responsible party
- Sponsor
- Investigators
- Caitlin Lees, MA, MSc, MD, FRCPC, Study chair, Nova Scotia Health AuthorityJonathan Clements, BSc, Principal investigator, Dalhousie UniversityLindsay Flinn, MD, CCFP (PC), Study chair, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924268
- Sponsor's protocol ID
- 2025060172580
- Status last verified
- Mar 2025
- First submitted
- 31 Mar 2025
- Last updated
- 17 Feb 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 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of a Single Art Therapy Session on Mood and Symptom Burden in Palliative Care Patients
- ClinicalTrials.gov ID
- NCT06924268
- Acronym / sponsor ID
- 2025060172580
- Conditions
- Emotional Distress, Pain, Anxiety
- Keywords
- Palliative, End of life, art therapy, quality of life
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Dalhousie University
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 11 Apr 2025 (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 goal of this observational study is to explore whether a single art therapy session can improve mood and reduce symptom burden in adult palliative care patients at a Canadian inpatient unit. The main questions it aims to answer are:
- Does a single art therapy session reduce overall symptom burden, as measured by the Edmonton Symptom Assessment System (ESAS)?
- Does a single art therapy session improve mood, as measured by the Positive and Negative Affect Schedule (PANAS)?
Participants will:
- Complete two short questionnaires (ESAS and PANAS) before and after the session
- Participate in a 30-60 minute individual art therapy session
Detailed description
This is a single-centre, prospective, observational pre-post study conducted at the QEII Health Sciences Centre, VG, 7A Palliative Care Unit. The aim is to evaluate whether a one-time, individualized art therapy session can positively impact emotional well-being and symptom distress in adults receiving inpatient palliative care.
Participants will be approached by the charge nurse and invited to participate if they meet the eligibility criteria. Following informed consent, participants will complete two validated self-report tools: the Edmonton Symptom Assessment System (ESAS) and the Positive and Negative Affect Schedule (PANAS). These assessments will be administered immediately before and again immediately after a 30-60 minute art therapy session, which will include open-ended creative engagement using simple materials such as watercolor and pastels.
The Study Objectives are:
- To determine whether participation in a structured art therapy session improves mood and symptom burden in palliative care patients
- Examine whether engagement in coloring activities influences emotional well-being as measured by the Positive and Negative Affect Schedule (PANAS) and symptom burden as measured by the Modified Edmonton Symptom Assessment System (ESAS).
- Is there a difference in as-needed (PRN) opioid, benzodiazepine, and Z drug use in the 48 hours before and after the session
- Examine whether specific patient characteristics, such as primary diagnosis or time from admission to intervention, impact the observed effects.
All data will be de-identified and analyzed descriptively and inferentially to assess trends in mood and symptom change following the intervention. This study does not involve randomization or a control group. It is designed to inform future research and program development in supportive care interventions within palliative settings.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Palliative Care In-Patients at the VG, 7A Palliative Care Unit
Key inclusion criteria (4 listed)
- admitted to the PCU
- have the ability to communicate
- complete self-assessments with or without facilitator assistance
- possess the ability to engage in a 30-60 minute art therapy session
Key exclusion criteria (3 listed)
- Patients will be excluded if they are under 18 years of age
- within 48hrs of admission or discharge
- experiencing severe cognitive impairment, uncontrolled symptoms, or delirium.
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 |
|---|---|---|
| Single Art Therapy SessionAlso: Visual arts therapy, Expressive artsEach participant will engage in a 30-60 minute structured art therapy session using pre-drawn coloring sheets featuring themes such as mandalas, nature scenes, and inspirational designs. A variety of coloring tools will be provided, including crayons, colored pencils, markers, gel pens, and watercolor paints. Sessions will be facilitated by the primary investigator, who will provide non-directive prompts and engage in casual conversation to foster comfort and engagement. | Behavioural | – |
Primary outcome
Change in Positive and Negative Affect Scores Measured by PANAS Before and After Art Therapy
Time frame: Immediately before and immediately after the art therapy session
The Positive and Negative Affect Schedule (PANAS) will be administered immediately before and immediately after a single art therapy session. PANAS is a self-reported 20-item scale measuring two mood domains: positive affect (10 items) and negative affect (10 items). Each item is rated on a scale from 1 (very slightly or not at all) to 5 (extremely), with subscale scores ranging from 10 to 50. Higher positive affect scores indicate more positive mood; higher negative affect scores indicate more distress.
Change in Symptom Burden Measured by Modified ESAS Before and After Art Therapy
Time frame: Immediately before and immediately after the art therapy session
The Edmonton Symptom Assessment System (ESAS) will be used to assess physical and emotional symptom burden immediately before and immediately after the art therapy session. ESAS consists of 9 core symptoms (e.g., pain, fatigue, nausea, anxiety, depression) each rated on a numeric scale from 0 (none) to 10 (worst possible severity). A total symptom score is calculated as the sum of all items, with higher scores indicating greater symptom burden. We will be using a modified version that does not include nausea, drowsiness, loss of appetite and dyspnea. The symptom "sadness" will be added to our assessment.
2 secondary outcomes
Changes in PRN Opioid Use in the 48 Hours Before and After Art Therapy
Time frame: 48 hours before and 48 hours after the art therapy session
Changes in PRN Benzodiazepine and Z-Drug Use in the 48 Hours Before and After Art Therapy
Time frame: 48 hours before and 48 hours after the art therapy session
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 Feb 2026.
- 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.
Caitlin Lees, MA, MSc, MD, FRCPC study chair
Nova Scotia Health Authority
Jonathan Clements, BSc principal investigator
Dalhousie University
Lindsay Flinn, MD, CCFP (PC) study chair
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emotional Distress and Pain, run by Nova Scotia Health Authority at 1 site in Canada.
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 4 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: enrolling by invitation, as of the sponsor's last update on 17 Feb 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 Canada. 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?
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 Positive and Negative Affect Scores Measured by PANAS Before and After Art Therapy (time frame: Immediately before and immediately after the art therapy session). 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 Feb 2026.