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临床试验/ACTRN12624000691549
ACTRN12624000691549招募中Unknown

Gastric motility rhythms response to heart rate variability biofeedback interventions in individuals with functional upper gastrointestinal disorders

The University of Auckland0 个研究点目标入组 20 人开始时间: 2024年5月30日最近更新:
适应症

试验速览

阶段
Unknown
状态
招募中
入组人数
20

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Non-randomised trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
16 Years 至 o limit(—)
性别
All

入选标准

  • Eligible participants must be at least 16 years old and meet Rome IV criteria for Functional Gastrointestinal Disorders (FGIDs), specifically limited to the upper gastrointestinal tract. This includes functional dyspepsia and chronic nausea and vomiting disorders or both if they meet criteria for both. Participants who also meet Rome IV criteria for disorders outside of the upper gastrointestinal system (i.e. irritable bowel syndrome) alongside their upper gastrointestinal disorder will not be excluded from the study. Participants must also be fluent in English and able to fully understand the risks and benefits of the research process.

排除标准

  • Individuals who have chronic gastrointestinal disorders and/or a history of gastrointestinal surgery will be excluded. Females who are pregnant and/or lactating will also be excluded. Participants who have a history of cardiac disease, arrhythmia, beta blockers, calcium channel blockers or other cardiac rate-control drugs will also be excluded.
  • Patients will be required to sit in a reclined position for the duration of the study and so participants who are not able to do so will be excluded from the study.
  • The adhesive array of electrodes used as part of the BSGM test has a slight risk of irritation post-removal (incidence rate 1-2%). Thus, participants who are susceptible to skin abrasions, tears and bruises as well as participants with allergies to adhesives will be excluded.

研究者

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