Application of Diaphragmatic Breathing in Patients With D... | NCT06205446

NCT06205446

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
abdominal breathing	Experimental	The relationship between respiration and the autonomic nervous system (ANS) is closely intertwined, as the phrenic nerve, responsible for controlling the movement of the diaphragm, is connected to the vagus nerve of the parasympathetic nervous system.The respiratory cycle reflects the balance between the parasympathetic and sympathetic nervous systems in the Autonomic Nervous System (ANS), which can be observed through Heart Rate Variability (HRV). The ANS state shifts from the parasympathetic nervous system to the sympathetic nervous system during inhalation, while it transitions from the sympathetic nervous system to the parasympathetic nervous system during exhalation. In HRV, an increase in heart rate indicates enhanced sympathetic nervous system activity during inhalation, whereas a decrease in heart rate signifies increased parasympathetic nervous system activity during exhalation.	Behavioral: Healthy subjects : abdominal breathing Behavioral: Laryngopharyngeal reflux disease subjects : abdominal breathing Behavioral: Dyspepsia subjects : abdominal breathing Behavioral: Irritable bowel disorder : abdominal breathing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Healthy subjects : abdominal breathing	Behavioral	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 14 Score - Baseline Score).	Baseline and day 14
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 14 Score - Baseline Score).	Baseline and day 14
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 14 Score - Baseline Score).	Baseline and day 14
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 14 Score - Baseline Score).	Baseline and day 14
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 14 Score - Baseline Score).	Baseline and day 14
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 14 Score - Baseline Score).

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Inclusion criteria for healthy subjects:

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.

Inclusion criteria for Laryngopharyngeal reflux disease subjects:

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.

dyspepsia subjects:

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).

Inclusion criteria for subjects with irritable bowel disorder:

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.

Facility	Status	City	State	ZIP	Country	Contacts
Hualien Tzu Chi Hospital		Hualien City		970	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33493503	Result	Margolis KG, Cryan JF, Mayer EA. The Microbiota-Gut-Brain Axis: From Motility to Mood. Gastroenterology. 2021 Apr;160(5):1486-1501. doi: 10.1053/j.gastro.2020.10.066. Epub 2021 Jan 22.
27147121	Result	Drossman DA, Hasler WL. Rome IV-Functional GI Disorders: Disorders of Gut-Brain Interaction. Gastroenterology. 2016 May;150(6):1257-61. doi: 10.1053/j.gastro.2016.03.035. No abstract available.

ID	Term
D043183	Irritable Bowel Syndrome
D005767	Gastrointestinal Diseases
D057045	Laryngopharyngeal Reflux

ID	Term
D003109	Colonic Diseases, Functional
D003108	Colonic Diseases
D007410	Intestinal Diseases
D004066	Digestive System Diseases
D005764	Gastroesophageal Reflux
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D007818	Laryngeal Diseases
D012140	Respiratory Tract Diseases