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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
10
Two one-hour chair-based yoga sessions that will include gentle movements, breathing practices, and meditation, along with home practice.
Atrium Health Gastroenterology and Hepatology Kenilworth
Charlotte, North Carolina, United States
RECRUITINGScreening Rate
Tracking the number of screened participants, those who are eligible, and the percent who agree to participate.
Time frame: Week 0
Recruitment Rate
Total number of patients who enrolled and proportion of patients eligible who enrolled
Time frame: Week 0
Retention Rate
Total number of participants who enrolled in the study who remained until completion
Time frame: 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.
Time frame: Week 2
Assessment Process Time
Amount of time needed for assessments.
Time frame: 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.
Time frame: Week 2
Client Satisfaction Questionnaire Score
Assesses satisfaction with treatment. Scores range from 8 to 32; higher scores indicate more satisfaction.
Time frame: Week 2
Intervention Usability Scale Score
Measures intervention usability. Scores range from 0-100; a score of 70 or greater may be considered adequate.
Time frame: Week 2
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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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 4