Functional Gastrointestinal Disorders, Healthy Subjects, Irritable Bowel Syndrome, Laryngopharyngeal Reflux
Conditions
Keywords
Heart rate variability, Diaphragmatic breathing, Gut-brain axis dysregulation
Brief 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 .
Interventions
BEHAVIORALHealthy subjects : abdominal breathing
The guidance content for the second session of self-practice in the first week involves practicing for 5 minutes each day, and recording a week-long diary of diaphragmatic breathing. After the first week, the subjects will undergo a once-off autonomic nervous system test and a questionnaire assessment of physical and mental symptoms. In the second week, the subjects will receive guidance for the second session of daily self-practice, practicing for 5 minutes each time, and recording a week-long diary of diaphragmatic breathing. After the second week, the subjects will undergo another round of autonomic nervous system testing and a questionnaire assessment of physical and mental symptoms.
BEHAVIORALLaryngopharyngeal reflux disease subjects : abdominal breathing
The guidance content for the second session of self-practice in the first week involves practicing for 5 minutes each day, and recording a week-long diary of diaphragmatic breathing. After the first week, the subjects will undergo a once-off autonomic nervous system test and a questionnaire assessment of physical and mental symptoms. In the second week, the subjects will receive guidance for the second session of daily self-practice, practicing for 5 minutes each time, and recording a week-long diary of diaphragmatic breathing. After the second week, the subjects will undergo another round of autonomic nervous system testing and a questionnaire assessment of physical and mental symptoms.
BEHAVIORALDyspepsia subjects : abdominal breathing
The guidance content for the second session of self-practice in the first week involves practicing for 5 minutes each day, and recording a week-long diary of diaphragmatic breathing. After the first week, the subjects will undergo a once-off autonomic nervous system test and a questionnaire assessment of physical and mental symptoms. In the second week, the subjects will receive guidance for the second session of daily self-practice, practicing for 5 minutes each time, and recording a week-long diary of diaphragmatic breathing. After the second week, the subjects will undergo another round of autonomic nervous system testing and a questionnaire assessment of physical and mental symptoms.
BEHAVIORALIrritable bowel disorder : abdominal breathing
The guidance content for the second session of self-practice in the first week involves practicing for 5 minutes each day, and recording a week-long diary of diaphragmatic breathing. After the first week, the subjects will undergo a once-off autonomic nervous system test and a questionnaire assessment of physical and mental symptoms. In the second week, the subjects will receive guidance for the second session of daily self-practice, practicing for 5 minutes each time, and recording a week-long diary of diaphragmatic breathing. After the second week, the subjects will undergo another round of autonomic nervous system testing and a questionnaire assessment of physical and mental symptoms.
Sponsors
Buddhist Tzu Chi General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion criteria for healthy subjects: 1. Age between 18 and 70, mentally alert and willing to sign the consent form for the study. 2. No gastrointestinal symptoms or use of gastrointestinal medication. Inclusion criteria for Laryngopharyngeal reflux disease subjects: 1. Age between 18 and 70, mentally alert and willing to sign the consent form for the study. 2. 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. dyspepsia subjects: 1. Age between 18 and 70, mentally alert and willing to sign the consent form for the study. 2. 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). Inclusion criteria for subjects with irritable bowel disorder: 1. Age between 18 and 70, mentally alert and willing to sign the consent form for the study. 2. 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
1. Pregnant or lactating women. 2. Infected with antibiotic resistance. 3. Received endotracheal intubation in the past two months . 4. Having myocardial ischemia or recently experienced a myocardial infarction. 5. Unable to collaborate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline on the Functional Dyspepsia Scale(FD) at 14 days | Baseline and day 14 | Possible scores range from 0 (Very slightly) to 6 (Very serious) 0=Very slightly 1=Slight 2=A little slightly 3=About medium 4=A bit serious 5=Severe 6=Very serious Change = (day 14 Score - Baseline Score). |
| Change from Baseline on the Irritable Bowel Syndrome Scale(IBS) at 14 days | Baseline and day 14 | Possible scores range from 1 (Never) to 5 (Always) 1=Never 2=Sometimes 3=Often4=most of the time 5=Always Change = (day 14 Score - Baseline Score). |
| Change from Baseline on the Gastroesophageal Reflux Disease Questionnaire(GERDQ) at 14 days | Baseline and day 14 | Possible scores range from 1 (Never) to 3 (4\ 7days) 0=Never 1=1 day 2=2\ 3days 3=4\ 7days Change = (day 14 Score - Baseline Score). |
| Change from Baseline on the Reflux Symptom Index (RSI) at 14 days | Baseline and day 14 | Possible scores range from 0 (no symptoms) to 5 (most severe) 0= No Problem 1=very slight 2=slight 3=About medium 4=moderate to severe 5=Severe Problem Change = (day 14 Score - Baseline Score). |
| Change from Baseline in Pain on the Gastrointestinal symptom rating scale (GSRS) at 14 days | Baseline and day 14 | Possible scores range from 1 (No pain) to 4 (Worst possible pain) 1=No pain 2=Mild 3=Moderate 4=Worst possible pain Change = (day 14 Score - Baseline Score). |
| Change from Baseline on the Pittsburgh sleep quality index (PSQI) at 14 days | Baseline and day 14 | Possible scores range from 0 (Never) to 3 (Occurs three times a week times or more) 0=Never 1=Less than once a week 2=Occurs once or twice a week 3=Occurs three times a week times or more Change = (day 14 Score - Baseline Score). |
| Change from Baseline on the Taiwanese Depression Scale (TDQ) at 14 days | Baseline and day 14 | Possible scores range from 0 (Never) to 3 (Always) 0=Never 1=Sometimes 2=Often 3=Always Change = (day 14 Score - Baseline Score). |
| Change from Baseline on the State-Trait Anxiety Inventory (STAI) at 14 days | Baseline and day 14 | Possible scores range from 1 (Never) to 4 (Always) 1=Never 2=Sometimes 3=Often 4=Always Change = (day 14 Score - Baseline Score). |
| Change from Baseline on the Perceived Stress Scale(PSS-10) at 14 days | Baseline and day 14 | Possible scores range from 0 (Never) to 4 (Always) 0=Never 1=Rarely 2=Sometimes 3=Often 4=Always Change = (day 14 Score - Baseline Score). |
| Change from Baseline on the Esophageal Hypervigilance and Anxiety Scale (EHAS) at 14 days | Baseline and day 14 | Possible scores range from 0 (Strongly disagree) to 4 (Strongly agree) 0=Strongly disagree 1=Somewhat disagree 2=Neiteher agree nor disagree 3=Somewhat agree 4 =Strongly agree Change = (day 14 Score - Baseline Score). |
| Change from Baseline on the Laryngeal Hypervigilance and Anxiety Scale (LHAS) at 14 days | Baseline and day 14 | Possible scores range from 0 (Strongly disagree) to 4 (Strongly agree) 0=Strongly disagree 1=Somewhat disagree 2=Neiteher agree nor disagree 3=Somewhat agree 4 =Strongly agree Change = (day 14 Score - Baseline Score). |
| Change from Baseline on the Visceral Sensitivity Index (VSI) at 14 days | Baseline and day 14 | Possible scores range from 1 (Strongly disagree) to 6 (Strongly agree) 1=Strongly agree 2=Moderately agree 3=Mildly agree 4=Mildly disagree 5 =Moderately disagree 6=Strongly disagree Change = (day 14 Score - Baseline Score). |
Countries
Taiwan
Outcome results
None listed