Functional Dyspepsia, Gastroparesis
Conditions
Keywords
Yoga, Disorders of the upper gastrointestinal (GI) tract, Brain-gut behavior
Brief summary
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).
Detailed description
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.
Interventions
OTHERSeated Yoga Skills Training in Functional Dyspepsia and Gastroparesis (FD-GP)
Two one-hour chair-based yoga sessions that will include gentle movements, breathing practices, and meditation, along with home practice.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years and older * Functional Dyspepsia or Gastroparesis (FP or GP) diagnosed by a physician using standard criteria * Signed, written consent
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Screening Rate | Week 0 | Tracking the number of screened participants, those who are eligible, and the percent who agree to participate. |
| Recruitment Rate | Week 0 | Total number of patients who enrolled and proportion of patients eligible who enrolled |
| Retention Rate | Week 2 | Total number of participants who enrolled in the study who remained until completion |
| Adherence Rate | 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 | Week 2 | Amount of time needed for assessments. |
| Acceptability of Intervention Score | 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 | Week 2 | Assesses satisfaction with treatment. Scores range from 8 to 32; higher scores indicate more satisfaction. |
| Intervention Usability Scale Score | 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 | 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 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORElyse Thakur, MD
Wake Forest University
Outcome results
None listed