Clinical trial NCT06924268: Impact of a Single Art Therapy Session on Mood and Symptom Burden in Palliative Care
Official title: Evaluating the Impact of a Single Art Therapy Session on Mood and Symptom Burden in Palliative Care Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Emotional Distress
Pain
Anxiety
Keywords: Palliative
End of life
art therapy
quality of life
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Dalhousie University
First posted: 2025-04-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Palliative Care In-Patients at the VG, 7A Palliative Care Unit

Brief 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. 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:

1. To determine whether participation in a structured art therapy session improves mood and symptom burden in palliative care patients
2. 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).
3. Is there a difference in as-needed (PRN) opioid, benzodiazepine, and Z drug use in the 48 hours before and after the session
4. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Positive and Negative Affect Scores Measured by PANAS Before and After Art Therapy
timeFrame: Immediately before and immediately after the art therapy session
measure: Change in Symptom Burden Measured by Modified ESAS Before and After Art Therapy
timeFrame: Immediately before and immediately after the art therapy session
Secondary outcomes:
measure: Changes in PRN Opioid Use in the 48 Hours Before and After Art Therapy
timeFrame: 48 hours before and 48 hours after the art therapy session
measure: Changes in PRN Benzodiazepine and Z-Drug Use in the 48 Hours Before and After Art Therapy
timeFrame: 48 hours before and 48 hours after the art therapy session
Other outcomes:
Locations:
Study officials:
affiliation: Nova Scotia Health Authority
name: Caitlin Lees, MA, MSc, MD, FRCPC
role: STUDY_CHAIR
affiliation: Dalhousie University
name: Jonathan Clements, BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Nova Scotia Health Authority
name: Lindsay Flinn, MD, CCFP (PC)
role: STUDY_CHAIR
References: