Social Evaluated Cold Pressor Test in Hereditary Angioedema Patients

Hereditary Angioedema Clinical Trial

— FROSEN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06414252
• Other study ID #: 2774CE
• Status: Completed
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 18, 2024
• Est. primary completion date: March 18, 2024
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Angioedema
• Hereditary Angioedema

Locations

Country	Name	City	State
Italy	Istituti Clinici Scientifici Maugeri	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituti Clinici Scientifici Maugeri SpA

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate	Changes in the heart rate (beats per minute) from resting to SECPT condition	Baseline
Primary	Systolic arterial pressure	Changes in the systolic blood pressure (mmHg) from resting to SECPT condition	Baseline
Primary	Diastolic arterial pressure	Changes in the systolic blood pressure (mmHg) from resting to SECPT condition	Baseline
Primary	Visual Analogue Scale of perceived stress	Changes in the perceived stress due to SECP. Scores ranges from 0 (no stress) to 100 (worst stress possible)	Baseline
Primary	Concentration of inflammatory cytokines	Changes in the concentration of inflammatory cytokines (pg/ml) due to SECPT	Baseline
Primary	Concentration of plasma cathecolamines	Changes in the concentration of plasma cathecolamines (pg/ml) due to SECPT	Baseline
Secondary	Hospital Anxiety and Depression Scale	A 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)	Baseline
Secondary	Perceived Stress Scale (PSS-10)	A 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).	Baseline
Secondary	Multidimensional Assessment of Interoceptive Awareness Version 1	A 32-item questionnaire to measure Interoceptive Awareness. Scores ranges from 0 (low interoceptive awareness) to 160 (high interoceptive awareness).	Baseline
Secondary	Body Appreciation Scale-2 (BAS-2)	A 10-item questionnaire to measure appreciation. Scores ranges from 10 (low body appreciation) to 50 (high body appreciation).	Baseline
Secondary	Functionality Appreciation Scale (FAS)	A 7-item questionnaire to measure body appreciation. Scores ranges from 0 (low functionality appreciation) to 35 (high functionality appreciation)	Baseline
Secondary	Pain Catastrophizing Scale (PCS)	A 13-item questionnaire to measure pain-related catastrophizing. Scores ranges from 0 (low catastrophizing ) to 52 (high catastrophizing).	Baseline