Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-27 @ 4:03 AM
Study NCT ID:
NCT06924268
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-11
First Post:
2025-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of a Single Art Therapy Session on Mood and Symptom Burden in Palliative Care
Sponsor:
Nova Scotia Health Authority
Organization:
Study Overview
Official Title:
Evaluating the Impact of a Single Art Therapy Session on Mood and Symptom Burden in Palliative Care Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
* 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: