To investigate the relationship between acute psychological stress and perception of acid in the distal oesophagus in healthy volunteers and GORD patients.
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
For both measurements time necessary to provoke first perception, discomfort
and pain during the acid perfusion will be assessed.
Secondary outcome
Systolic and diastolic blood pressure (mmHg) and heart rate (beats/min) will be
assessed during both measurements in order to assess the reaction to mental
stress task.
The State and Trait Anxiety Inventory (STAI)/Zelf Beoordelings Vragenlijst
(ZBV) is scored before introducing the manometry and pH catheter on both
measurement days.
The pH recording will show pH levels in the distal oesophagus during the acid
perfusion test continuously. Afterwards, total time with pH<4 will be
calculated and presented in minutes.
Background summary
Many patients with gastro-oesophageal reflux disease (GORD) report an
association between stress and symptoms of GORD. Results of studies using
experimentally induced stress show an increase in symptoms but no increase in
objective reflux parameters. This points towards a role of hypersensitivity to
gastro-oesophageal reflux during stressful circumstances. We hypothesize that
the sensitivity of the distal oesophagus to acid might be modulated by acute
stress.
Study objective
To investigate the relationship between acute psychological stress and
perception of acid in the distal oesophagus in healthy volunteers and GORD
patients.
Study design
The study consists of two parts. First the study is conducted with healthy
volunteers. After all measurements are completed, the same measurements are
performed with GORD patients. All participants will undergo stationairy
manometry, pH monitoring and an acid perfusion test twice, one measurement
without and one with the presence of an acute psychological stressor. The order
of these two measurements will be randomized. Before each measurement
participants will fill in a questionnaire om order to compare subjects'anxiety
scores on the two different days. We will use a modified Raven Progressive
Matrices IQ test to induce psychological stress.
Study burden and risks
Participants will undergo routine stationairy oesophageal manometry, pH
monitoring and acid perfusion test twice. There will be one week between woth
measurements. Oesophageal manometry and pH monitoring are routine
investigations at our department and involve no risks for the participants.
Heidelberglaan 100
3584 CX Utrecht
Nederland
Heidelberglaan 100
3584 CX Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
Healthy volunteers: no symptoms/history of gastro-oesophageal reflux disease
Patients with gastro-oesophageal reflux disease: previously diagnosed with gastro-oesophageal reflux disease with good association between symptoms and reflux episodes
Exclusion criteria
Surgery of the gastro-intestinal tract
Psychiatric disorders
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL20540.041.07 |