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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
125
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.
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.
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.
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.
Hualien Tzu Chi Hospital
Hualien City, Taiwan
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Baseline and day 14
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 14 Score - Baseline Score).
Time frame: Baseline and day 14
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 14 Score - Baseline Score).
Time frame: Baseline and day 14
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 14 Score - Baseline Score).
Time frame: Baseline and day 14
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 14 Score - Baseline Score).
Time frame: Baseline and day 14
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 14 Score - Baseline Score).
Time frame: Baseline and day 14
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 14 Score - Baseline Score).
Time frame: Baseline and day 14
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