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| ID | Type | Description | Link |
|---|---|---|---|
| 400983697 | Other Identifier | American Neurogastroenterology and Motility Society |
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The purpose of this research study is to assess whether using a yoga-based intervention in practice is feasible (possible) and acceptable to patients with Functional Dyspepsia and/or Gastroparesis (FD-GP).
This research looks to adapt an existing seated yoga intervention, designed for patients with GI cancer, for testing in patients with disorders of the upper GI tract by conducting a field test with FD-GP patients to assess feasibility and acceptability and refine the adapted intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Seated Yoga Intervention | Experimental | Two one-hour yoga sessions with home practice administered individually by a yoga interventionist in GI clinic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seated Yoga Skills Training in Functional Dyspepsia and Gastroparesis (FD-GP) | Other | Two one-hour chair-based yoga sessions that will include gentle movements, breathing practices, and meditation, along with home practice. |
| Measure | Description | Time Frame |
|---|---|---|
| Screening Rate | Tracking the number of screened participants, those who are eligible, and the percent who agree to participate. | Week 0 |
| Recruitment Rate | Total number of patients who enrolled and proportion of patients eligible who enrolled | Week 0 |
| Retention Rate | Total number of participants who enrolled in the study who remained until completion | Week 2 |
| Adherence Rate | Completion of 75% of the planned in-person sessions will be considered adherent; home practice will be tracked via daily logs sent back to study team electronically. | Week 2 |
| Assessment Process Time | Amount of time needed for assessments. | Week 2 |
| Acceptability of Intervention Score | Overall acceptability of intervention. Target acceptability ratings of at least 4 (agree/completely agree) on a scale of 1 to 5, with a score of 5 being the most acceptable. | Week 2 |
| Client Satisfaction Questionnaire Score | Assesses satisfaction with treatment. Scores range from 8 to 32; higher scores indicate more satisfaction. | Week 2 |
| Intervention Usability Scale Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elyse Thakur, MD | Wake Forest University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health Gastroenterology and Hepatology Kenilworth | Charlotte | North Carolina | 28204 | United States |
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| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
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Measures intervention usability. Scores range from 0-100; a score of 70 or greater may be considered adequate. |
| Week 2 |
| Visual analog scale for pain (VAS) score | Acute effects using a VAS scale of nausea and psychological distress ranging 0 (none at all) to 100 (as much as there could be) before and after each session to assess immediate relief of symptoms. Higher scores indicate more nausea and psychological distress. | Week 1, Week 2 |
| Semi-Structured Interview | 30-minute qualitative interview for perspectives on the barriers and facilitators to program engagement and suggestions for improvement, benefits of yoga intervention, and specific questions about format, usability, and burden of the intervention and current and future assessments. Key domains corresponding to the research goals will be developed based on the interview guide. All responses within each domain will be summarized to identify key findings which will be used to inform adaptation of the intervention. | Week 2 |
| Semi-Structured Interview | 30-minute qualitative interview for perspectives on the barriers and facilitators to program engagement and suggestions for improvement, benefits of yoga intervention, and specific questions about format, usability, and burden of the intervention and current and future assessments. Key domains corresponding to the research goals will be developed based on the interview guide. All responses within each domain will be summarized to identify key findings which will be used to inform adaptation of the intervention. | Week 3 |
| Semi-Structured Interview | 30-minute qualitative interview for perspectives on the barriers and facilitators to program engagement and suggestions for improvement, benefits of yoga intervention, and specific questions about format, usability, and burden of the intervention and current and future assessments. Key domains corresponding to the research goals will be developed based on the interview guide. All responses within each domain will be summarized to identify key findings which will be used to inform adaptation of the intervention. | Week 4 |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |