Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414252
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2024-05-07
Brief Title:
Social Evaluated Cold Pressor Test in Hereditary Angioedema Patients
Sponsor:
Istituti Clinici Scientifici Maugeri SpA
Organization:
Istituti Clinici Scientifici Maugeri SpA
Study Overview
Official Title:
Functional Physiological Psychological and Biochemical Reactivity to Social Evaluated Cold Pressor Test in Hereditary Angioedema Patients
Status:
COMPLETED
Status Verified Date:
2024-05
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:
FROSEN
Brief 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
Detailed 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
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