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Social Evaluated Cold Pressor Test in Hereditary Angioedema Patients

Functional Physiological, Psychological and Biochemical Reactivity to Social Evaluated Cold Pressor Test in Hereditary Angioedema Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06414252
Acronym
FROSEN
Enrollment
40
Registered
2024-05-16
Start date
2023-05-15
Completion date
2024-03-18
Last updated
2024-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hereditary Angioedema

Keywords

Hereditary Angioedema, Autonomic nervous system, Cold pressor test, Stress, Body appreciation, Rare disease

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.

Interventions

None listed

Sponsors

Istituti Clinici Scientifici Maugeri SpA
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years

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).

Design outcomes

Primary

MeasureTime frameDescription
Concentration of plasma cathecolaminesBaselineChanges in the concentration of plasma cathecolamines (pg/ml) due to SECPT
Heart rateBaselineChanges in the heart rate (beats per minute) from resting to SECPT condition
Systolic arterial pressureBaselineChanges in the systolic blood pressure (mmHg) from resting to SECPT condition
Diastolic arterial pressureBaselineChanges in the systolic blood pressure (mmHg) from resting to SECPT condition
Visual Analogue Scale of perceived stressBaselineChanges in the perceived stress due to SECP. Scores ranges from 0 (no stress) to 100 (worst stress possible)
Concentration of inflammatory cytokinesBaselineChanges in the concentration of inflammatory cytokines (pg/ml) due to SECPT

Secondary

MeasureTime frameDescription
Hospital Anxiety and Depression ScaleBaselineA 14-item questionnaire subdivided in two subscales to measure anxiety and depression. Scores for each subscale ranges from 0 (absence of symptoms) to 21 (significant symptoms)
Perceived Stress Scale (PSS-10)BaselineA 10-item questionnaire to measure stress levels related to the perception of unpredicable, uncontrollable, and overloading nature of life. Scores ranges from 0 (low levels) to 40 (high levels).
Multidimensional Assessment of Interoceptive Awareness Version 1BaselineA 32-item questionnaire to measure Interoceptive Awareness. Scores ranges from 0 (low interoceptive awareness) to 160 (high interoceptive awareness).
Body Appreciation Scale-2 (BAS-2)BaselineA 10-item questionnaire to measure appreciation. Scores ranges from 10 (low body appreciation) to 50 (high body appreciation).
Functionality Appreciation Scale (FAS)BaselineA 7-item questionnaire to measure body appreciation. Scores ranges from 0 (low functionality appreciation) to 35 (high functionality appreciation)
Pain Catastrophizing Scale (PCS)BaselineA 13-item questionnaire to measure pain-related catastrophizing. Scores ranges from 0 (low catastrophizing ) to 52 (high catastrophizing).

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026