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临床试验/NCT06924268
NCT06924268Enrolling By Invitation不适用

Evaluating the Impact of a Single Art Therapy Session on Mood and Symptom Burden in Palliative Care Patients

Nova Scotia Health Authority1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
20
试验地点
1
主要终点
Change in Positive and Negative Affect Scores Measured by PANAS Before and After Art Therapy

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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.

结局指标

主要结局

Change in Positive and Negative Affect Scores Measured by PANAS Before and After Art Therapy

时间窗: 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

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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