Application of Diaphragmatic Breathing in Patients With Disorders of Gut-brain Interaction (NCT06205446) | Clinical Trial Compass
CompletedNot Applicable
Application of Diaphragmatic Breathing in Patients With Disorders of Gut-brain Interaction
Taiwan125 participantsStarted 2023-09-01
Plain-language summary
Patients with disorders of gut-brain interaction (DGBI) often present gastrointestinal symptoms that do not show noticeable irregularities in standard examinations. However, due to unclear causes and a high prevalence rate, this condition often exerts a profound impact on the physical and mental health of patients. The scope of DGBI encompasses conditions such as laryngopharyngeal reflux, functional dyspepsia, and irritable bowel syndrome. Previous research has confirmed that in patients with DGBI, their autonomic nervous system exhibits an imbalance, charact erized by decreased parasympathetic activity and dominant sympathetic activity. Diaphragmatic breathing helps reduce the respiratory rate and can stimulate parasympathetic activity while suppressing sympathetic activity. Hence, it is now officially recommended as an effective adjunct therapy for relieving symptoms of gastroesophageal reflux. Accordingly, this study plans to implement a randomized controlled trial, introducing diaphragmatic breathing to patients with DGBI who exhibit normal results in objective examinations. This work allows evaluate changes in their psychophysical symptoms before and after treatment, as well as alterations in the autonomic nervous system .
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Age between 18 and 70, mentally alert and willing to sign the consent form for the study.
✓. No gastrointestinal symptoms or use of gastrointestinal medication.
✓. Age between 18 and 70, mentally alert and willing to sign the consent form for the study.
✓. Gastroesophageal reflux disease (GERD) is defined as the condition characterized by experiencing symptoms for at least three months (such as hoarseness, sensation of a foreign body in the throat, chronic cough, and frequent throat clearing) occurring at least once a week. Reflux Symptom Index (RSI) is a standardized questionnaire for evaluating laryngopharyngeal reflux. It consists of nine reflux-related symptoms, with severity scores ranging from 0 (no symptoms) to 5 (most severe). A total score exceeding 13 indicates the criteria for inclusion of a patient as having laryngopharyngeal reflux.
✓. Age between 18 and 70, mentally alert and willing to sign the consent form for the study.
✓. Those who meet the definition of functional dyspepsia (FD). (Functional dyspepsia is chronic ( once a week , lasting for at least three months, at least six months before the first symptom) upper gastrointestinal symptoms (any of the following ) : postprandial abdominal distension, easy feeling of fullness, upper abdominal pain Or upper abdominal burning sensation, and no symptoms of gastrointestinal bleeding or significant weight loss, no abnormality after upper gastrointestinal endoscopy).
What they're measuring
1
Change from Baseline on the Functional Dyspepsia Scale(FD) at 14 days
Timeframe: Baseline and day 14
2
Change from Baseline on the Irritable Bowel Syndrome Scale(IBS) at 14 days
Timeframe: Baseline and day 14
3
Change from Baseline on the Gastroesophageal Reflux Disease Questionnaire(GERDQ) at 14 days
Timeframe: Baseline and day 14
4
Change from Baseline on the Reflux Symptom Index (RSI) at 14 days
Timeframe: Baseline and day 14
5
Change from Baseline in Pain on the Gastrointestinal symptom rating scale (GSRS) at 14 days
Timeframe: Baseline and day 14
6
Change from Baseline on the Pittsburgh sleep quality index (PSQI) at 14 days
Timeframe: Baseline and day 14
7
Change from Baseline on the Taiwanese Depression Scale (TDQ) at 14 days
Timeframe: Baseline and day 14
8
Change from Baseline on the State-Trait Anxiety Inventory (STAI) at 14 days
✓. Age between 18 and 70, mentally alert and willing to sign the consent form for the study.
✓. meet the definition of irritable bowel disorder (IBS) . Irritable bowel syndrome is chronic ( once a week , lasting for at least three months) lower gastrointestinal symptoms: abdominal pain combined with diarrhea or constipation , and no symptoms of gastrointestinal bleeding or significant weight loss, no abnormalities after colonoscopy) .
Exclusion criteria
✕. Pregnant or lactating women.
✕. Infected with antibiotic resistance.
✕. Received endotracheal intubation in the past two months .
✕. Having myocardial ischemia or recently experienced a myocardial infarction.
✕. Unable to collaborate.
Timeframe: Baseline and day 14
9
Change from Baseline on the Perceived Stress Scale(PSS-10) at 14 days
Timeframe: Baseline and day 14
10
Change from Baseline on the Esophageal Hypervigilance and Anxiety Scale (EHAS) at 14 days
Timeframe: Baseline and day 14
11
Change from Baseline on the Laryngeal Hypervigilance and Anxiety Scale (LHAS) at 14 days
Timeframe: Baseline and day 14
12
Change from Baseline on the Visceral Sensitivity Index (VSI) at 14 days