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NCT Number: NCT06205446

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

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 .

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Functional Gastrointestinal Disorders Gastroesophageal Reflux Gastrointestinal Diseases Healthy Subjects Intestinal Diseases Laryngeal Diseases Laryngopharyngeal Reflux Respiratory Tract Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hualien Tzu Chi Hospital

Hualien City, 970, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Laryngopharyngeal reflux disease 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.

Dyspepsia 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.

Irritable bowel disorder : 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.

Primary outcomes

  1. Change from Baseline on the Functional Dyspepsia Scale(FD) at 14 days

    Time frame: 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).

  2. Change from Baseline on the Irritable Bowel Syndrome Scale(IBS) at 14 days

    Time frame: 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).

  3. Change from Baseline on the Gastroesophageal Reflux Disease Questionnaire(GERDQ) at 14 days

    Time frame: 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).

  4. Change from Baseline on the Reflux Symptom Index (RSI) at 14 days

    Time frame: 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).

  5. Change from Baseline in Pain on the Gastrointestinal symptom rating scale (GSRS) at 14 days

    Time frame: 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).

  6. Change from Baseline on the Pittsburgh sleep quality index (PSQI) at 14 days

    Time frame: 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).

  7. Change from Baseline on the Taiwanese Depression Scale (TDQ) at 14 days

    Time frame: 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).

  8. Change from Baseline on the State-Trait Anxiety Inventory (STAI) at 14 days

    Time frame: 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).

  9. Change from Baseline on the Perceived Stress Scale(PSS-10) at 14 days

    Time frame: 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).

  10. Change from Baseline on the Esophageal Hypervigilance and Anxiety Scale (EHAS) at 14 days

    Time frame: 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).

  11. Change from Baseline on the Laryngeal Hypervigilance and Anxiety Scale (LHAS) at 14 days

    Time frame: 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).

  12. Change from Baseline on the Visceral Sensitivity Index (VSI) at 14 days

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Buddhist Tzu Chi General Hospital

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 16, 2024
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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