NCT06924268

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
3mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress80%
Jun 2025Aug 2026

First Submitted

Initial submission to the registry

March 31, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 11, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

February 17, 2026

Status Verified

March 1, 2025

Enrollment Period

1.2 years

First QC Date

March 31, 2025

Last Update Submit

February 13, 2026

Conditions

Keywords

PalliativeEnd of lifeart therapyquality of life

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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

    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

    48 hours before and 48 hours after the art therapy session

Interventions

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.

Also known as: Visual arts therapy, Expressive arts

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Palliative Care In-Patients at the VG, 7A Palliative Care Unit

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nova Scotia Health

Halifax, Nova Scotia, B3H 1V7, Canada

Location

MeSH Terms

Conditions

PainAnxiety DisordersDeath

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersPathologic Processes

Study Officials

  • Caitlin Lees, MA, MSc, MD, FRCPC

    Nova Scotia Health Authority

    STUDY CHAIR
  • Jonathan Clements, BSc

    Dalhousie University

    PRINCIPAL INVESTIGATOR
  • Lindsay Flinn, MD, CCFP (PC)

    Nova Scotia Health Authority

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2025

First Posted

April 11, 2025

Study Start

June 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

February 17, 2026

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations