- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07717541
Virtual Poetry Workshops to Enhance Patient Well Being and Reduce Anxiety
Poetry Workshops to Enhance Patient Well-Being and Reduce Anxiety Levels
This study examines whether participating in poetry workshops can improve emotional well-being among patients with chronic digestive symptoms. Many individuals with long-standing digestive conditions experience distress, anxiety, isolation, and difficulty expressing their emotions in clinical settings. These emotional challenges can negatively affect daily life, relationships, and overall health.
Poetry writing offers a creative and supportive way for participants to explore their feelings, express their experiences, and build emotional resilience. It also allows individuals to focus on aspects of their identity beyond their illness.
The purpose of this research is to evaluate whether poetry workshops can reduce anxiety, lessen feelings of isolation, and strengthen participants' sense of community and well being.
1. Why is this study being done?
The purpose of this research study is to offer a creative outlet for patients to explore their identity and story, build resilience, and seek hope. This study is being done because we understand that the psychological discomfort that can come upon hearing a diagnosis can lead to increased anxiety levels, negatively impacting a patient's well-being and relationships. Often healthcare practitioners may merely view a patient through the lens of their diagnosis, neglecting other aspects of their identity and humanity. Through reading various poems, crafting their own poems, and sharing their work with their peers, we hope the workshops offer a comforting opportunity for the participants to explore their identities and creativity.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Upon hearing a diagnosis, patients can feel overwhelmed and apprehensive as they experience a loss of control over their current state of health. This psychological discomfort combined with often life-threatening symptoms can result in increased anxiety levels in patients. While patient anxiety levels remain a critical issue for investigation, patients diagnosed with illnesses such as cancer often experience a lack of attention from providers towards their psychological wellbeing (Rickett et al. 2011). As a result, patients can feel consumed by their emotions and find difficulty in navigating the psychological complexities of a diagnosis.
The arts, especially poetry, can provide a powerful vessel through which patients can authentically and vulnerably communicate the myriad of emotions they experience. While poetry may not alter the reality of a diagnosis, it can help shift the patient's attitude from one of fear to one of hope. In addition, the active practice of writing poetry can present an opportunity for patients to regain a sense of control and recognize how their identity is more than their diagnosis.
Moreover, patients are rarely asked "What does this all mean to you?" when they are diagnosed with an illness (Rickett et al. 2011). Poetry workshops can serve as a "transformational space" where patients can reflect on their illness journey and seek meaning in their experiences (Rickett et al. 2011). In addition, poetry workshops can offer opportunities for community building and engagement which "is rare within the highly clinical treatment environment" (Tegner et al. 2009). By sharing poems with one another, patients can seek unity in their experiences and lend support to one another, leading to reductions in isolation. It has been reported that poetry can enhance skills such as listening, attentiveness, and observation which are all critical for relationship building (Barrett et al. 2020).
Previous studies have assessed the effects of poetry workshops on patients with serious illnesses; however, the need for more information surrounding this interdisciplinary approach remains pertinent. One study found that poetry therapy interventions improved both emotional resilience and anxiety in cancer patients (Tegner et. al 2009). In another study, poetry intervention was reported to have led to significant decreases in sadness, worry, and fatigue in hospitalized pediatric patients (Delamerced 2021).
This study aims to take both a qualitative and quantitative approach to understanding how poetry workshops can foster community, lessen anxiety, and enhance emotional well-being among patients diagnosed with at least moderate dyspepsia and moderate anxiety or depression
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: SUBHANKAR CHAKRABORTY, M.D., Ph.D.
- Номер телефона: 614-293-6255'
- Электронная почта: Subhankar.chakraborty@osumc.edu
Места учебы
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Ohio
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Columbus, Ohio, Соединенные Штаты, 43210
- Рекрутинг
- Ohio State University Wexner Medical Center
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Контакт:
- Subhankar Chakraborty, MD, Ph.D.
- Номер телефона: 614-293-6255'
- Электронная почта: subhankar.chakraborty@osumc.edu
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
• At least 18 years old
- Ability to provide informed consent
- Able to speak and understand English
- Able to attend virtual poetry workshops
- Willing to share at least 3 poems at the end of the study with the study team
- Have access to a high-speed internet connection and smart phone or computer
- Willing to participate in group activity if randomized to the facilitated workshops
- At least moderate dyspepsia assessed by the Dyspepsia questionnaire (at least one of the following symptoms with moderate or worse severity- nausea, vomiting, early satiety, post prandial fullness AND
- At least moderate anxiety or depression assessed by HADS questionnaire. The HADS score has 2 subscores- HADS-A for anxiety and HADS-D for depression. A score of ≥ 21 indicates moderate anxiety and will be required to be eligible for the study.
Exclusion Criteria:
- Unable to speak English or participate in virtual sessions
- Younger than 18 years old
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: Experimental group
Participants selected for the facilitated poetry workshop will meet once a week for approximately 1.5 hours via Zoom.
Before each workshop, participants will complete a survey evaluating their general emotional state.
Each session will begin with a 10-minute warm-up relating to the workshop's theme to ease the participants into the workshop and to cultivate a comfortable environment for the participants to discuss with one another.
The warmup will be followed by the facilitator reading a poem and a discussion of the poem.
This discussion will pertain to the participants' initial thoughts and emotions upon hearing the poem.
Afterwards, participants will have the opportunity to craft their own poem and share their art with their fellow participants.
The workshop will close with a final reading of the poem by one of the participants.
At the end of each workshop, patients will complete a survey evaluating their emotional state,
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participants will have the opportunity to craft their own poem and share their art with their fellow participants.
This will be facilitated by one of the research team members who will help them craft their own poem.
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Активный компаратор: Control Group
Participants will be provided with a manual with the selected poems, reflection questions, and writing prompts.
In accordance with the 8-week schedule followed by the facilitated poetry workshops, participants in the control group will partake in each of the 8 workshops and complete the surveys outside of the scheduled virtual group sessions.
The last workshop will be conducted in an interview-style format.
After every two workshops, a member of the research team will call each participant to check in on their progress.
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Participants will receive a written manual that will guide them on how to write poetry.
they will receive one manual each week.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Change in Anxiety and Depression Symptoms
Временное ограничение: Between baseline and 8 weeks after start of poetry sessions
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Assessed using the HADS questionnaire
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Between baseline and 8 weeks after start of poetry sessions
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Change in Dyspepsia Symptoms
Временное ограничение: Assessed from Baseline to end of poetry sessions (8 weeks)
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This will be assessed using electronic questionnaire that asks them to rate dyspepsia symptoms on a scale from None- Very severe
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Assessed from Baseline to end of poetry sessions (8 weeks)
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Subhankar CHAKRABORTY, MD, Ph.D., Ohio State University
Публикации и полезные ссылки
Общие публикации
- Gaillard R, Mir O. Fluoxetine and motor recovery after ischaemic stroke. Lancet Neurol. 2011 Jun;10(6):499; author reply 500-1. doi: 10.1016/S1474-4422(11)70111-9. No abstract available.
- Lee B, Mafi J, Patel MK, Sorensen A, Vangala S, Wei E, Sarkisian C. Quality improvement time-saving intervention to increase use of a clinical decision support tool to reduce low-value diagnostic imaging in a safety net health system. BMJ Open Qual. 2021 Feb;10(1):e001076. doi: 10.1136/bmjoq-2020-001076.
- Barrett E, Dickson M, Hayes-Brady C, Wheelock H. Storytelling and poetry in the time of coronavirus. Ir J Psychol Med. 2020 Dec;37(4):278-282. doi: 10.1017/ipm.2020.36. Epub 2020 May 14.
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Неврологические проявления
- Психические расстройства
- Признаки и симптомы, пищеварительный тракт
- Поведенческие симптомы
- Заболевания пищеварительной системы
- Желудочно-кишечные заболевания
- Заболевания желудка
- Паралич
- Патологические состояния, признаки и симптомы
- Поведение
- Признаки и симптомы
- Тревожные расстройства
- Депрессия
- Диспепсия
- Гастропарез
Другие идентификационные номера исследования
- STUDY20250588
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .