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

January 11, 2024 updated by: Buddhist Tzu Chi General Hospital

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

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 .

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Hualien City, Taiwan, 970
        • Recruiting
        • Hualien Tzu Chi Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: abdominal breathing
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
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.
Behavioral: 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.
Behavioral: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline on the Functional Dyspepsia Scale(FD) at 14 days
Time Frame: Baseline and day 28
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
Change from Baseline on the Irritable Bowel Syndrome Scale(IBS) at 14 days
Time Frame: Baseline and day 28

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
Change from Baseline on the Gastroesophageal Reflux Disease Questionnaire(GERDQ) at 14 days
Time Frame: Baseline and day 28
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
Change from Baseline on the Reflux Symptom Index (RSI) at 14 days
Time Frame: Baseline and day 28
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
Change from Baseline in Pain on the Gastrointestinal symptom rating scale (GSRS) at 14 days
Time Frame: Baseline and day 28

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
Change from Baseline on the Pittsburgh sleep quality index (PSQI) at 14 days
Time Frame: Baseline and day 28
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
Change from Baseline on the Taiwanese Depression Scale (TDQ) at 14 days
Time Frame: Baseline and day 28
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
Change from Baseline on the State-Trait Anxiety Inventory (STAI) at 14 days
Time Frame: Baseline and day 28

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
Change from Baseline on the Perceived Stress Scale(PSS-10) at 14 days
Time Frame: Baseline and day 28
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
Change from Baseline on the Esophageal Hypervigilance and Anxiety Scale (EHAS) at 14 days
Time Frame: Baseline and day 28
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
Change from Baseline on the Laryngeal Hypervigilance and Anxiety Scale (LHAS) at 14 days
Time Frame: Baseline and day 28
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
Change from Baseline on the Visceral Sensitivity Index (VSI) at 14 days
Time Frame: Baseline and day 28

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Buddhist Tzu Chi General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

December 28, 2023

First Submitted That Met QC Criteria

January 11, 2024

First Posted (Estimated)

January 15, 2024

Study Record Updates

Last Update Posted (Estimated)

January 15, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB112-185-A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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