[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07717541":3,"trial-entities:NCT07717541":117,"trial-summary:NCT07717541":120},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":31,"primary_purpose":32,"phases":33,"enrollment_info":35,"interventions":38,"primary_outcomes":50,"secondary_outcomes":59,"sex":60,"minimum_age":61,"maximum_age":62,"healthy_volunteers":15,"eligibility_criteria":63,"std_ages":78,"locations":81,"central_contacts":97,"overall_officials":101,"references":105,"see_also_links":116},"NCT07717541","STUDY20250588","Virtual Poetry Workshops to Enhance Patient Well Being and Reduce Anxiety","Poetry Workshops to Enhance Patient Well-Being and Reduce Anxiety Levels","RECRUITING","2028-12-31","2026-07","2026-07-21","2026-07-17","Ohio State University","OTHER",false,"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.\n\nPoetry 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.\n\nThe 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.\n\n1\\. Why is this study being done?\n\nThe 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.","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.\n\nThe 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.\n\nMoreover, 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).\n\nPrevious 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).\n\nThis 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",[19,20,21,22],"Dyspepsia","Gastroparesis","Anxiety","Depression",[24,25,26,27,28,29,30],"poetry","anxiety","depression","dyspepsia","gastroparesis","virtual","creativity","INTERVENTIONAL","SUPPORTIVE_CARE",[34],"NA",{"count":36,"type":37},80,"ESTIMATED",[39,45],{"type":40,"name":41,"description":42,"armGroupLabels":43},"BEHAVIORAL","Poetry","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.",[44],"Experimental group",{"type":40,"name":46,"description":47,"armGroupLabels":48},"Poetry Manual","Participants will receive a written manual that will guide them on how to write poetry. they will receive one manual each week.",[49],"Control Group",[51,55],{"measure":52,"description":53,"timeFrame":54},"Change in Anxiety and Depression Symptoms","Assessed using the HADS questionnaire","Between baseline and 8 weeks after start of poetry sessions",{"measure":56,"description":57,"timeFrame":58},"Change in Dyspepsia Symptoms","This will be assessed using electronic questionnaire that asks them to rate dyspepsia symptoms on a scale from None- Very severe","Assessed from Baseline to end of poetry sessions (8 weeks)",[],"ALL","18 Years",null,{"inclusion":64,"exclusion":74,"raw_text":77},[65,66,67,68,69,70,71,72,73],"• 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.",[75,76],"Unable to speak English or participate in virtual sessions","Younger than 18 years old","Inclusion Criteria:\n\n* • At least 18 years old\n\n  * Ability to provide informed consent\n  * Able to speak and understand English\n  * Able to attend virtual poetry workshops\n  * Willing to share at least 3 poems at the end of the study with the study team\n  * Have access to a high-speed internet connection and smart phone or computer\n  * Willing to participate in group activity if randomized to the facilitated workshops\n  * 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\n  * 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.\n\nExclusion Criteria:\n\n* Unable to speak English or participate in virtual sessions\n* Younger than 18 years old",[79,80],"ADULT","OLDER_ADULT",[82],{"facility":83,"status":8,"city":84,"state":85,"zip":86,"country":87,"contacts":88,"geoPoint":94},"Ohio State University Wexner Medical Center","Columbus","Ohio","43210","United States",[89],{"name":90,"role":91,"phone":92,"email":93},"Subhankar Chakraborty, MD, Ph.D.","CONTACT","614-293-6255'","subhankar.chakraborty@osumc.edu",{"lat":95,"lon":96},39.96118,-82.99879,[98],{"name":99,"role":91,"phone":92,"email":100},"SUBHANKAR CHAKRABORTY, M.D., Ph.D.","Subhankar.chakraborty@osumc.edu",[102],{"name":103,"affiliation":13,"role":104},"Subhankar CHAKRABORTY, MD, Ph.D.","PRINCIPAL_INVESTIGATOR",[106,110,113],{"pmid":107,"type":108,"citation":109},"21601157","BACKGROUND","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\u002FS1474-4422(11)70111-9. No abstract available.",{"pmid":111,"type":108,"citation":112},"33579745","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\u002Fbmjoq-2020-001076.",{"pmid":114,"type":108,"citation":115},"32406356","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\u002Fipm.2020.36. Epub 2020 May 14.",[],{"nct_id":4,"conditions":118,"biomarkers":119},[21,22,19,20],[],{"nct_id":4,"found":121,"summary":122,"prompt_version":132},true,{"design":123,"status":124,"heading":125,"summary":126,"follow_up":127,"word_count":128,"commitments":129,"compensation":130,"drugs_mentioned":131},"This is an interventional study with a planned enrollment of 80 participants. It is not specified if it is randomized or blinded.","completed","Virtual Poetry Workshops for Well-being and Anxiety","This study is exploring whether participating in virtual poetry workshops can help improve emotional well-being and reduce anxiety and depression in people who have chronic digestive conditions like dyspepsia (indigestion) or gastroparesis (a condition that affects stomach emptying). Many people with these conditions experience stress, anxiety, and difficulty expressing their feelings. The study will involve 80 participants who will either take part in poetry workshops, where they can write and share their own poems with guidance, or receive a poetry manual weekly to help them write. Researchers will measure changes in anxiety, depression, and dyspepsia symptoms over 8 weeks to see if poetry helps. You may be able to join if you are at least 18, speak English, have internet access, and are willing to share poems.","Changes in anxiety, depression, and dyspepsia symptoms will be assessed from baseline to 8 weeks after the start of poetry sessions.",127,"Participants will attend virtual poetry workshops or receive weekly poetry manuals. They will be asked to share at least 3 poems with the study team at the end of the study.","Not stated in the trial record.",[41,46],"v2"]