Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06151067
Status:
COMPLETED
Last Update Posted:
2023-11-30
First Post:
2023-11-20
Brief Title:
Important Correlation Between Anxiety and Reflux Symptoms in Patients With Gastroesophageal Reflux Disease
Sponsor:
Evangelic Hospital Kalk Cologne
Organization:
Evangelic Hospital Kalk Cologne
Study Overview
Official Title:
Important Correlation Between Anxiety and Reflux Symptoms in Patients With Gastroesophageal Reflux Disease
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Gastroesophageal reflux disease GERD is one of the most common gastroenterological disorders with a reported prevalence of 10 to 20 percent in Europe and the USA and less than 5 in Asia GERD manifests as heartburn regurgitation retrosternal pain cough and in some cases dysphagia and holds the possible complication of a Barretts esophagus GERD can appear as non-erosive NERD or erosive ERD Comorbid symptoms of anxiety and depression are common in GERD patients The association between anxiety or depression and reflux symptoms has been investigated in previous studies under the aspects of whether existing reflux symptomatology leads to increased anxiety and depression or whether anxiety and depression lead to more severe reflux symptoms There is a an interaction between GERD and psychosocial disorders
A long duration of GERD was associated with higher levels of anxiety and depression and women were more likely to have these symptoms In patients with Barretts esophagus a complication of GERD in which the mucosal cells of the esophagus under constant exposure to stomach acid change into a different type of cell normally found in the intestinal tract rates of anxiety and depression have been reported to be three to five times higher than in the general population
Anxiety and depression as well as adverse events in life are also independent risk factors for NERD Patients with NERD show an increased risk for anxiety compared with patients with ERD
The reporting of somatic symptoms is multifactorial and influenced by psychosocial factors such as socioeconomic status sex and mental distress A high somatic symptom load is known to increase anxiety related to health issues psychological distress and health care utilization The increased sensation to visceral stimuli in which anxiety and depression play an important role has been discussed as visceral hypersensitivity
Several studies of patients with reflux symptoms have used the Hopsital Anxiety and Depression Scale HADS score as a measure of anxiety and depression and have reported higher anxiety scores than depression scores for this cohort
The aim of this study was to assess anxiety and depression levels of patients with physiological as well as with pathological DeMeester scores Further the modulation of anxiety on the severity of reflux symptoms such as fullness heartburn and dysphagia is examined
A long duration of GERD was associated with higher levels of anxiety and depression and women were more likely to have these symptoms In patients with Barretts esophagus a complication of GERD in which the mucosal cells of the esophagus under constant exposure to stomach acid change into a different type of cell normally found in the intestinal tract rates of anxiety and depression have been reported to be three to five times higher than in the general population
Anxiety and depression as well as adverse events in life are also independent risk factors for NERD Patients with NERD show an increased risk for anxiety compared with patients with ERD
The reporting of somatic symptoms is multifactorial and influenced by psychosocial factors such as socioeconomic status sex and mental distress A high somatic symptom load is known to increase anxiety related to health issues psychological distress and health care utilization The increased sensation to visceral stimuli in which anxiety and depression play an important role has been discussed as visceral hypersensitivity
Several studies of patients with reflux symptoms have used the Hopsital Anxiety and Depression Scale HADS score as a measure of anxiety and depression and have reported higher anxiety scores than depression scores for this cohort
The aim of this study was to assess anxiety and depression levels of patients with physiological as well as with pathological DeMeester scores Further the modulation of anxiety on the severity of reflux symptoms such as fullness heartburn and dysphagia is examined
Detailed Description:
Introduction
Gastroesophageal reflux disease GERD is one of the most common gastroenterological disorders with a reported prevalence of 10 to 20 percent in Europe and the USA and less than 5 in Asia GERD manifests as heartburn regurgitation retrosternal pain cough and in some cases dysphagia and holds the possible complication of a Barretts esophagus GERD can appear as non-erosive NERD or erosive ERD In the diagnosis of the reflux disease the DeMeester score is used as a measure of esophageal acid exposure time Important differential diagnosis are benign functional disorders of the esophagus such as is functional heartburn or functional dysphagia Comorbid symptoms of anxiety and depression are common The association between anxiety or depression and reflux symptoms has been investigated in previous studies under the aspects of whether existing reflux symptomatology leads to increased anxiety and depression or whether anxiety and depression lead to more severe reflux symptoms The results are inconsistent In younger patients 18 - 40 years with gastroesophageal reflux disease GERD the prevalence of anxiety and depression is higher than in those without GERD There is an independent association between GERD anxiety and current depression Patients with anxiety are more likely to experience GERD symptoms and these symptoms seem to be more severe in anxious patients Anxiety and depression intensify symptom perception Patients with GERD have a higher incidence of anxiety depression and sleep disturbances than those without GERD and there is an association between psychosocial disorders and an increased risk of anxiety Thus there is a an interaction between GERD and psychosocial disorders which has been discussed as the psychoemotional effects of GERD GERD is considered to be an independent source of stress
A long duration of GERD was associated with higher levels of anxiety and depression and women were more likely to have these symptoms In patients with Barretts esophagus a complication of GERD in which the mucosal cells of the esophagus under constant exposure to stomach acid change into a different type of cell normally found in the intestinal tract rates of anxiety and depression have been reported to be three to five times higher than in the general population
Anxiety and depression as well as adverse events in life are also independent risk factors for NERD Patients with NERD show an increased risk for anxiety compared with patients with ERD
The reporting of somatic symptoms is multifactorial and influenced by psychosocial factors such as socioeconomic status sex and mental distress A high somatic symptom load is known to increase anxiety related to health issues psychological distress and health care utilization The increased sensation to visceral stimuli in which anxiety and depression play an important role has been discussed as visceral hypersensitivity
Several studies of patients with reflux symptoms have used the Hopsital Anxiety and Depression Scale HADS score as a measure of anxiety and depression and have reported higher anxiety scores than depression scores for this cohort
The aim of this study was to assess anxiety and depression levels of patients with physiological as well as with pathological DeMeester scores Furthermore the modulation of anxiety on the severity of reflux symptoms such as fullness heartburn and dysphagia is examined
2 Methods Statement of ethics The present study was conducted according to Declaration of Helsinki principles and was approved by the Ethics Committee of the Medical Faculty of the University of Cologne All patients provided their online informed consent The study has not been registered in any study register
Study design We conducted a prospective observational cohort study with one measurement time on admission
Participants We enrolled all patients who were referred to the Reflux and swallowing problems center of the Clinic for General and Visceral Surgery of the University Hospital Cologne Germany between January 2020 and July 2021 Only patients were included for analysis who completed the HADS-D All patients underwent gastrointestinal function diagnostics with esophagogastroduodenoscopy 24-hour pH-metry high-resolution manometry and esophagography Psychometric data were collected using the HADS The criteria for indication for surgery were positive DMS presence of hiatal hernia changes in the esophagus due to reflux such as Barrett esophagus or inflammation poor tolerance of medication low level of symptom control through medication and lifestyle decreased quality of life long duration of the disease and substantial comorbidities Not all criteria needed to be fullfied
Questionnaires We used the HADS in its German version for assessing anxiety HADS-A and depression levels HADS-D Self-report is used to assess the severity of anxious and depressive symptoms during the past week which is recorded on two subscales with seven items each each item ranging from 0 - 3 adding up to a maximal total score of 21 For both subscales a cutoff score for caseness of 8 is recommended 27
Data analysis In evaluating the HADS scores we labeled scores on the subscales of HADS-A of 8 and over 8 as anxious and those on the subscale of HADS-D of 8 and over 8 as depressed We differentiated between mildly HADS score on the subscale 8-10 moderately HADS 11 - 14 and severely HADS 15 - 21 anxious or depressed
The DMS was determined using 24h pH impedance testing which included the following values in the score percentage of time with esophageal pH 4 of the total measurement period percentage of time with pH 4 during the waking phase upright position percentage of time with pH 4 during sleep phase supine position total number of reflux episodes during the measurement period number of reflux episodes with duration 5 min duration of the longest reflux episode
In evaluating the DMS we labeled scores as negative physiological 1472 or positive pathological 1472 The positive scores were differentiated into mild 1472 - 30 moderate 30 - 80 and severe 80
Statistical Analysis Statistical analysis was performed using IBM SPSS Statistics Continuous variables were presented as mean and standard deviation categorical data as frequencies with percentages To identify differences between two groups an independent samples T-test was performed for parametric data whereas a Mann-Whitney U test was performed for non-parametric data Furthermore a Chi-square test for independence or Fischers Exact test respectively was performed in case of categorical data Correlation between parameters was investigated using Pearson correlation coefficient for parametric data and Spearman correlation coefficient for non-parametric data A p-value 005 was considered statistically significant
Gastroesophageal reflux disease GERD is one of the most common gastroenterological disorders with a reported prevalence of 10 to 20 percent in Europe and the USA and less than 5 in Asia GERD manifests as heartburn regurgitation retrosternal pain cough and in some cases dysphagia and holds the possible complication of a Barretts esophagus GERD can appear as non-erosive NERD or erosive ERD In the diagnosis of the reflux disease the DeMeester score is used as a measure of esophageal acid exposure time Important differential diagnosis are benign functional disorders of the esophagus such as is functional heartburn or functional dysphagia Comorbid symptoms of anxiety and depression are common The association between anxiety or depression and reflux symptoms has been investigated in previous studies under the aspects of whether existing reflux symptomatology leads to increased anxiety and depression or whether anxiety and depression lead to more severe reflux symptoms The results are inconsistent In younger patients 18 - 40 years with gastroesophageal reflux disease GERD the prevalence of anxiety and depression is higher than in those without GERD There is an independent association between GERD anxiety and current depression Patients with anxiety are more likely to experience GERD symptoms and these symptoms seem to be more severe in anxious patients Anxiety and depression intensify symptom perception Patients with GERD have a higher incidence of anxiety depression and sleep disturbances than those without GERD and there is an association between psychosocial disorders and an increased risk of anxiety Thus there is a an interaction between GERD and psychosocial disorders which has been discussed as the psychoemotional effects of GERD GERD is considered to be an independent source of stress
A long duration of GERD was associated with higher levels of anxiety and depression and women were more likely to have these symptoms In patients with Barretts esophagus a complication of GERD in which the mucosal cells of the esophagus under constant exposure to stomach acid change into a different type of cell normally found in the intestinal tract rates of anxiety and depression have been reported to be three to five times higher than in the general population
Anxiety and depression as well as adverse events in life are also independent risk factors for NERD Patients with NERD show an increased risk for anxiety compared with patients with ERD
The reporting of somatic symptoms is multifactorial and influenced by psychosocial factors such as socioeconomic status sex and mental distress A high somatic symptom load is known to increase anxiety related to health issues psychological distress and health care utilization The increased sensation to visceral stimuli in which anxiety and depression play an important role has been discussed as visceral hypersensitivity
Several studies of patients with reflux symptoms have used the Hopsital Anxiety and Depression Scale HADS score as a measure of anxiety and depression and have reported higher anxiety scores than depression scores for this cohort
The aim of this study was to assess anxiety and depression levels of patients with physiological as well as with pathological DeMeester scores Furthermore the modulation of anxiety on the severity of reflux symptoms such as fullness heartburn and dysphagia is examined
2 Methods Statement of ethics The present study was conducted according to Declaration of Helsinki principles and was approved by the Ethics Committee of the Medical Faculty of the University of Cologne All patients provided their online informed consent The study has not been registered in any study register
Study design We conducted a prospective observational cohort study with one measurement time on admission
Participants We enrolled all patients who were referred to the Reflux and swallowing problems center of the Clinic for General and Visceral Surgery of the University Hospital Cologne Germany between January 2020 and July 2021 Only patients were included for analysis who completed the HADS-D All patients underwent gastrointestinal function diagnostics with esophagogastroduodenoscopy 24-hour pH-metry high-resolution manometry and esophagography Psychometric data were collected using the HADS The criteria for indication for surgery were positive DMS presence of hiatal hernia changes in the esophagus due to reflux such as Barrett esophagus or inflammation poor tolerance of medication low level of symptom control through medication and lifestyle decreased quality of life long duration of the disease and substantial comorbidities Not all criteria needed to be fullfied
Questionnaires We used the HADS in its German version for assessing anxiety HADS-A and depression levels HADS-D Self-report is used to assess the severity of anxious and depressive symptoms during the past week which is recorded on two subscales with seven items each each item ranging from 0 - 3 adding up to a maximal total score of 21 For both subscales a cutoff score for caseness of 8 is recommended 27
Data analysis In evaluating the HADS scores we labeled scores on the subscales of HADS-A of 8 and over 8 as anxious and those on the subscale of HADS-D of 8 and over 8 as depressed We differentiated between mildly HADS score on the subscale 8-10 moderately HADS 11 - 14 and severely HADS 15 - 21 anxious or depressed
The DMS was determined using 24h pH impedance testing which included the following values in the score percentage of time with esophageal pH 4 of the total measurement period percentage of time with pH 4 during the waking phase upright position percentage of time with pH 4 during sleep phase supine position total number of reflux episodes during the measurement period number of reflux episodes with duration 5 min duration of the longest reflux episode
In evaluating the DMS we labeled scores as negative physiological 1472 or positive pathological 1472 The positive scores were differentiated into mild 1472 - 30 moderate 30 - 80 and severe 80
Statistical Analysis Statistical analysis was performed using IBM SPSS Statistics Continuous variables were presented as mean and standard deviation categorical data as frequencies with percentages To identify differences between two groups an independent samples T-test was performed for parametric data whereas a Mann-Whitney U test was performed for non-parametric data Furthermore a Chi-square test for independence or Fischers Exact test respectively was performed in case of categorical data Correlation between parameters was investigated using Pearson correlation coefficient for parametric data and Spearman correlation coefficient for non-parametric data A p-value 005 was considered statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None