- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06924268
Impact of a Single Art Therapy Session on Mood and Symptom Burden in Palliative Care
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
- Nova Scotia Health
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- inclusion if they are adults (=18 years old)
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Immediately before and immediately after the art therapy session
|
|
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.
|
Immediately before and immediately after the art therapy session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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.
|
48 hours before and 48 hours after the art therapy session
|
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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
|
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.
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48 hours before and 48 hours after the art therapy session
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Caitlin Lees, MA, MSc, MD, FRCPC, Nova Scotia Health Authority
- Principal Investigator: Jonathan Clements, BSc, Dalhousie University
- Study Chair: Lindsay Flinn, MD, CCFP (PC), Nova Scotia Health Authority
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025060172580
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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