Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06414252 |
| Other study ID # |
2774CE |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 15, 2023 |
| Est. completion date |
March 18, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
Istituti Clinici Scientifici Maugeri SpA |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This study aims to evaluate the differences in objective and subjective stress responses
between patients with hereditary angioedema and healthy individuals to a stress-induced
challenge like socially-evaluated cold pressure test. The study also investigates the role of
psychological variables in influencing the stress response.
Description:
Stressful encounters, ranging from daily hassles to major life events, are ubiquitous in our
everyday lives and are often responsible for significant changes in affective and cognitive
processes. In various physical diseases, including hereditary angioedema (HAE) due to C1
inhibitor deficiency, stressful events are also frequently reported by patients to trigger
acute attacks. These include physical stress (such as injury, pain, viral infections, medical
and dental procedures, and surgery) and mental stress (including stress from life events and
school or work, clinical depression, and anxiety), or stress originating from the disease
itself, especially if the disease is characterized by an unpredictable nature like HEA that
directly impacts patients' choices in everyday life. Available literature related to the link
between HAE and stress is limited and mainly focused on the patients' narratives.
Self-reported data suggested that the main HAE trigger seems to be stress, followed by
physical trauma. These observations suggest analyzing the perceived psychological effects
consequent to stress exposure together with biochemical and physiological responses. The
effect of stress could be systematically examined in a laboratory environment using a
standardized protocol that reliably induces stress and activates major stress responses in
experimental contexts. A reliable test to induce stress in HAE patients combining these two
aspects may be the Socially Evaluated Cold Pressor Test (SECPT). SECPT is an extension of the
classical Cold Pressor Test, in which participants immerse one of their hands in ice water
with socio-evaluative elements, and has been proven to be a highly efficient tool for
experimental stress induction in humans. Adding social-evaluative elements to the original
physical stress boosted the cortisol response, making the SECPT a well-established standard
protocol in human stress research that may represent an efficient alternative to other
established protocols, such as the Trier Social Stress Test, a 'gold standard' in the field.
A recent review confirmed that exposure to the SECPT leads to changes in subjective feeling,
and triggers a significant sharp increase in systolic and diastolic blood pressure. The
present study aims to evaluate objective and subjective stress responses between HAE patients
and healthy controls due to SECPT. Moreover, as secondary aims, the study wants to
investigate if the presence of anxiety and depressive symptoms, as well as body appreciation,
trust in the body, pain catastrophizing, pain interference, and pain intensity, affect or
mediate stress response in patients and healthy subjects similarly or differently.
