Clinical trial NCT06732453: Brain-Gut Yoga for Functional Dyspepsia and Gastroparesis (FD-GP)
Official title: Adaptation of the Yoga Skills Training for Relief of Nausea and Vomiting in Patients With Functional Dyspepsia and Gastroparesis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Functional Dyspepsia
Gastroparesis
Keywords: Yoga
Disorders of the upper gastrointestinal (GI) tract
Brain-gut behavior
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2024-12-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Screening Rate
timeFrame: Week 0
measure: Recruitment Rate
timeFrame: Week 0
measure: Retention Rate
timeFrame: Week 2
measure: Adherence Rate
timeFrame: Week 2
measure: Assessment Process Time
timeFrame: Week 2
measure: Acceptability of Intervention Score
timeFrame: Week 2
measure: Client Satisfaction Questionnaire Score
timeFrame: Week 2
measure: Intervention Usability Scale Score
timeFrame: Week 2
measure: Visual analog scale for pain (VAS) score
timeFrame: Week 1, Week 2
measure: Semi-Structured Interview
timeFrame: Week 2
measure: Semi-Structured Interview
timeFrame: Week 3
measure: Semi-Structured Interview
timeFrame: Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Atrium Health Gastroenterology and Hepatology Kenilworth
state: North Carolina
Study officials:
affiliation: Wake Forest University
name: Elyse Thakur, MD
role: PRINCIPAL_INVESTIGATOR
References: