Clinical trial NCT06414252: Social Evaluated Cold Pressor Test in Hereditary Angioedema Patients
Official title: Functional Physiological, Psychological and Biochemical Reactivity to Social Evaluated Cold Pressor Test in Hereditary Angioedema Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hereditary Angioedema
Keywords: Hereditary Angioedema
Autonomic nervous system
Cold pressor test
Stress
Body appreciation
Rare disease
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The group of patients with hereditary angioedema were recruited during an out-patient visit in a tertiary care center. The group of healthy individuals were volunteers recruited from community.

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.

Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of hereditary angioedema due to C1 inhibitor deficiency aged between 18 and 65 years (for the group of patients)

Exclusion Criteria:

* Any type of chronic disease requiring chronic treatment (i.e. hypertension, previous myocardial infarction, diabetes, chronic heart failure, autoimmune disease, neurodegenerative disease)
* Active acute disease;
* Sars-Cov2 infection in the previous 3 months.
* An acute attack experienced within the previous week and within 72 hours after the registration (a posteriori exclusion).

Primary outcomes:
measure: Heart rate
timeFrame: Baseline
measure: Systolic arterial pressure
timeFrame: Baseline
measure: Diastolic arterial pressure
timeFrame: Baseline
measure: Visual Analogue Scale of perceived stress
timeFrame: Baseline
measure: Concentration of inflammatory cytokines
timeFrame: Baseline
measure: Concentration of plasma cathecolamines
timeFrame: Baseline
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale
timeFrame: Baseline
measure: Perceived Stress Scale (PSS-10)
timeFrame: Baseline
measure: Multidimensional Assessment of Interoceptive Awareness Version 1
timeFrame: Baseline
measure: Body Appreciation Scale-2 (BAS-2)
timeFrame: Baseline
measure: Functionality Appreciation Scale (FAS)
timeFrame: Baseline
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Baseline
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituti Clinici Scientifici Maugeri
Study officials:
References: