Application of Diaphragmatic Breathing in Patients With Disorders of Gut-brain Interaction

Healthy Subjects Clinical Trial

Official title:

Application of Diaphragmatic Breathing in Patients With Disorders of Gut-brain Interaction: Impact on Gastrointestinal and Psychological Symptoms as Well as Autonomic Nervous System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06205446
• Other study ID #: IRB112-185-A
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Buddhist Tzu Chi General Hospital
• Contact: Ming-Wun Wong
• Phone: +886 8561825
• Email: hypertr42[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Digestive System Diseases
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases
• Healthy Subjects
• Irritable Bowel Syndrome
• Laryngopharyngeal Reflux

Intervention

Behavioral:
• Healthy 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.
• Laryngopharyngeal 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.
• Dyspepsia 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.
• Irritable 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.

Locations

Country	Name	City	State
Taiwan	Hualien Tzu Chi Hospital	Hualien City

Sponsors (1)

Lead Sponsor	Collaborator
Buddhist Tzu Chi General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (45)

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* Note: There are 45 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline on the Functional Dyspepsia Scale(FD) at 14 days	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 28 Score - Baseline Score).	Baseline and day 28
Primary	Change from Baseline on the Irritable Bowel Syndrome Scale(IBS) at 14 days	Possible scores range from 1 (Never) to 5 (Always); 1=Never 2=Sometimes 3=Often4=most of the time 5=Always Change = (day 28 Score - Baseline Score).	Baseline and day 28
Primary	Change from Baseline on the Gastroesophageal Reflux Disease Questionnaire(GERDQ) at 14 days	Possible scores range from 1 (Never) to 3 (4~7days) 0=Never 1=1 day 2=2~3days 3=4~7days Change = (day 28 Score - Baseline Score).	Baseline and day 28
Primary	Change from Baseline on the Reflux Symptom Index (RSI) at 14 days	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 28 Score - Baseline Score).	Baseline and day 28
Primary	Change from Baseline in Pain on the Gastrointestinal symptom rating scale (GSRS) at 14 days	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 28 Score - Baseline Score).	Baseline and day 28
Primary	Change from Baseline on the Pittsburgh sleep quality index (PSQI) at 14 days	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 28 Score - Baseline Score).	Baseline and day 28
Primary	Change from Baseline on the Taiwanese Depression Scale (TDQ) at 14 days	Possible scores range from 0 (Never) to 3 (Always) 0=Never 1=Sometimes 2=Often 3=Always Change = (day 28 Score - Baseline Score).	Baseline and day 28
Primary	Change from Baseline on the State-Trait Anxiety Inventory (STAI) at 14 days	Possible scores range from 1 (Never) to 4 (Always); 1=Never 2=Sometimes 3=Often 4=Always Change = (day 28 Score - Baseline Score).	Baseline and day 28
Primary	Change from Baseline on the Perceived Stress Scale(PSS-10) at 14 days	Possible scores range from 0 (Never) to 4 (Always) 0=Never 1=Rarely 2=Sometimes 3=Often 4=Always Change = (day 28 Score - Baseline Score).	Baseline and day 28
Primary	Change from Baseline on the Esophageal Hypervigilance and Anxiety Scale (EHAS) at 14 days	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 28 Score - Baseline Score).	Baseline and day 28
Primary	Change from Baseline on the Laryngeal Hypervigilance and Anxiety Scale (LHAS) at 14 days	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 28 Score - Baseline Score).	Baseline and day 28
Primary	Change from Baseline on the Visceral Sensitivity Index (VSI) at 14 days	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 28 Score - Baseline Score).	Baseline and day 28