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临床试验/NCT06554431
NCT06554431已完成不适用

Assessing the Efficacy of Self-Driven Repetitive Artmaking Practice on Pain and Mood States for Patients With Chronic Pain, Opioid Use Disorder, and Opioid Misuse

Montefiore Medical Center1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2024年7月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
1
主要终点
Feasibility of the Intervention

研究概览

简要总结

The primary purpose of this study is to assess the acceptability of self-directed art making for people with chronic pain and OUD/opioid misuse, or to state it another way, whether people with chronic pain and OUD/opioid misuse will realistically do this artistic practice on their own.

A secondary question of this study is to explore whether doing this art practice can help minimize pain during the artistic process, lessen depression and anxiety, and improve feelings of social connection.

详细描述

The pilot is an exploratory evaluation of whether repetitive artmaking in home environments is acceptable for chronic pain self-management in individuals with OUD/opioid misuse, and whether self-driven repetitive artmaking can offer respite from pain, depression, and anxiety, and improve social connectivity.

The study will recruit 40 individuals living with chronic pain with an OUD diagnosis or opioid misuse from a Montefiore-led methadone clinic. The Principal Investigators (PIs) will collaborate with an Art Therapist to develop three (3) simple art kits. Patients will participate in an in-person art workshop, to be held in English with the support of a Spanish translator, and complete pre- and post-surveys assessing in-the moment pain, anxiety, depression, and social connectivity. Patients will be given all three (3) kits to take home and to complete the same pre- and post-surveys and art kits at home up to four (4) times within a four-month period to assess real-world adoptability and efficacy. The art kits will not include any visible information about Montefiore or the study in the front of the packets; paper versions of the survey will be enclosed within the kits, to support confidentiality. A subset of patients will be invited to a virtual meaning making group to capture qualitative feedback. The study staff will not share the names of patients with anyone outside the core research team - the co-PIs, Study Coordinator, Patient Advocate, Biostatistician, Art Therapist, and Photographer and Exhibit Coordinator. All patients will be invited to have their art photographed and share their experience of the artmaking process and how it relates to their chronic pain and opioid use.

Photographs and stories will be shared on the Montefiore campus as an art exhibit, and the layperson audience will be surveyed to assess any resultant alteration in feelings of stigma toward the population of those living with chronic pain and OUD/opioid misuse. Patients who share their artwork will be able to decide if their name (or a portion of their name) or a pseudonym will be included in the exhibit alongside their artwork, or whether maintaining anonymity is preferred.

Implementation:

In-Person Workshop: An Art Therapist, will lead three (3) two-hour in-person workshops, with all patients required to attend one (1) in-person workshop as part of this study. Spanish translation will be available at all workshops. The purpose of these workshops are twofold: gather patient characteristic data (demographics, Pain Catastrophizing Survey, questions on experience with art and openness to mindfulness) and orient patients to the use of the art kits available to them to take and use at home. The art therapist will develop three (3) repetitive artmaking kit options and will develop enough for patients to leave the workshop with one of each kit. Options include mandala painting, weaving, and stamp making kits. As previously stated, the art kits will be compiled to minimize visual identification from others that are part of a research study, with all survey materials asking sensitive questions buried in the middle of the packet. At the start of the in-person workshop, PI will orient patients to the pilot goals and activities, answer all questions, collect consent forms, and provide the link to the pre-survey assessing pain and mood as well as paper versions of the survey. The art therapist will provide an engaging overview of the three available kits, and patients will select a kit to try for the in-person workshop. PI will be present to provide Spanish translation and explanation as necessary. The last 15 minutes of the workshop will be saved for patients to complete the post-survey on pain and mood. Finally, patients will be informed that they will be invited to bring their artistic outputs to be photographed by a professional photographer at the end of the four month period and to share their experiences of making the art, so that they can share what they have made with the broader community.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • Experience chronic pain
  • Have received medication for OUD in the past 30 days or meet criteria for opioid misuse
  • Are aged 18 or older
  • Are fluent in English and/or Spanish

排除标准

  • Are not fluent in either English or Spanish
  • Are unable to participate in and complete the introductory workshop due to language or other barriers - physical disabilities are not exclusionary
  • Do not otherwise meet the inclusion criteria for age, OUD, Opioid misuse, and chronic pain.

研究组 & 干预措施

Art Making

Experimental

Each patient will receive artmaking kits

干预措施: Self-Driven Repetitive Artmaking (Behavioral)

结局指标

主要结局

Feasibility of the Intervention

时间窗: 4 months

Feasibility of the intervention will be measured quantitatively by the number of patients who complete the pre- and post-survey up to four (4) times. Results are summarized.

Acceptability of the Intervention

时间窗: 4 months

Acceptability of the intervention was assessed as a composite measure. Specifically, acceptability was assessed based on the number of participants who both responded affirmatively during training sessions as to whether they used the art kits at home AND also similarly reported to the Study Coordinator (SC) during monthly check-ins they engaged with the art kits on their own time. The number of participants who both responded 'Yes' on the survey and reported home use during monthly check-ins is summarized.

次要结局

  • Social Connectivity(Before and after a microintervention within a 24 hour period, up to 4 months)
  • Current Level of Pain(Before and after a microintervention within a 24 hour period, up to 4 months)
  • Mood Outcomes - Anxiety(Before and after a microintervention within a 24 hour period, up to 4 months)
  • Mood Outcomes - Depression(Before and after a microintervention within a 24 hour period, up to 4 months)
  • Previous Week Pain - at Its Worst(Before the workshop and before each microintervention within a 24 hour period, up to 4 months)
  • Previous Week Pain - at Its Least(Before the workshop and before each microintervention within a 24 hour period, up to 4 months)
  • Pain Catastrophizing Experience(Before the workshop, within 24 hours)
  • Non-prescribed Opioid Use(Before the workshop and before each microintervention within a 24-hour period, up to 4 months)
  • Level of Intoxication(Before and after a microintervention within a 24 hour period, up to 4 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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