Adaptation of the Yoga Skills Training for Relief of Nausea and Vomiting in Patients With Functional Dyspepsia and Gastroparesis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Screening Rate
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 否
入选标准
- •18 years and older
- •Functional Dyspepsia or Gastroparesis (FP or GP) diagnosed by a physician using standard criteria
- •Signed, written consent
排除标准
- •Co-morbid Gastrointestinal or related disorders documents in the medical record: celiac disease, inflammatory Bowel Disease(active), gastrointestinal obstruction (if current in the last 6 months), any GI surgery within the last 6 months), chronic pancreatitis or any pancreatic or biliary disease, cirrhosis or any chronic liver disease other than metabolic associated hepatic disease (MASH), any malignancy (except skin cancer already resected and surgically in remission)
- •A positive screen for the following: current psychotic symptoms, elevated suicide risk, active eating disorder, cognitive impairment, current harmful alcohol or substance use
- •Does not understand English
- •Underwent a regular yoga or other mediative movement practice (tai chi or qi gong) in the past 6 month
研究组 & 干预措施
Seated Yoga Intervention
Two one-hour yoga sessions with home practice administered individually by a yoga interventionist in GI clinic
干预措施: Seated Yoga Skills Training in Functional Dyspepsia and Gastroparesis (FD-GP) (Other)
结局指标
主要结局
Screening Rate
时间窗: Week 0
Tracking the number of screened participants, those who are eligible, and the percent who agree to participate.
Recruitment Rate
时间窗: Week 0
Total number of patients who enrolled and proportion of patients eligible who enrolled
Retention Rate
时间窗: Week 2
Total number of participants who enrolled in the study who remained until completion
Adherence Rate
时间窗: Week 2
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.
Assessment Process Time
时间窗: Week 2
Amount of time needed for assessments.
Acceptability of Intervention Score
时间窗: Week 2
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.
Client Satisfaction Questionnaire Score
时间窗: Week 2
Assesses satisfaction with treatment. Scores range from 8 to 32; higher scores indicate more satisfaction.
Intervention Usability Scale Score
时间窗: Week 2
Measures intervention usability. Scores range from 0-100; a score of 70 or greater may be considered adequate.
Visual analog scale for pain (VAS) score
时间窗: Week 1, Week 2
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.
Semi-Structured Interview
时间窗: Week 4
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.
Semi-Structured Interview
时间窗: Week 2
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.
Semi-Structured Interview
时间窗: Week 3
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.
次要结局
未报告次要终点