Table 1 Steps and measures of the study
Step | Variable | Instrument | Measure | Procedure duration |
|---|---|---|---|---|
1. | Weather sensitivity | Questionnaire (short form) | The Palanga Weather Sensitivity Self-Assessment Diary (PSAD-WS) will be completed to assess weather sensitivity [22]. PSAD-WS is an 11-item (general) three-factor tool for collecting information regarding weather sensitivity in patients with CAD. The three subscales reflected (1) psychological symptoms, (2) cardiac symptoms and (3) physical. Also, patients will be asked a single question: “Do you feel the weather changes?” with possible answers of “NO” or “YES”. | up to 2 min |
2. | Cortisol level | Saliva samples will be obtained using “SaliCap Set“ releasing the saliva into the sampling tubes. Samples will then be stored at -70oC and cortisol levels will be determined in a licensed laboratory using commercial reagent kits. | To assess hypothalamic pituitary adrenocortial (HPA) axis activity, cortisol will be sampled and assayed from participants’ saliva. | up to 20 min |
3. | Sociodemographic characteristics and clinical history | Medical records | Age, sex, education, medical history [i.e., New York Heart Association (NYHA) functional class, history of ACS, and angina pectoris class], and medication. | up to 15 min |
4. | Functional capacity | The six-minute walk test (6MWT) [34] | The 6MWT will be performed in a 30 m hallway and will be monitored by a physiotherapist. The patient will instructed to remain calm, to have taken his/her medications and to wear comfortable clothing and shoes. All tests will be performed between 8:00 am and 12:00 am in a quiet indoor hallway with a flat straight floor. The floor will be marked in 1 m increments and total distance covered will be recorded. Participants will be asked to walk at their own pace, while attempting to cover as much ground as possible within the allotted six minutes. Every minute, a physiotherapist will encourage subjects to continue walking and inform them of the time elapsed, using standardized phrases (“You are doing well” or “Keep up the good work”). The patient’s heart rate, BP will be measured before and after the test. Any symptoms experienced by the patient during this test will also be recorded (Borg scale) [35]. The distance walked will be recorded after the test. | up to 10 min |
5. | Mental health outcomes | The PHQ assesses 8 diagnoses, divided into threshold disorders (disorders that correspond to specific diagnoses in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, specifically major depressive disorder, panic disorder, other anxiety disorder, and bulimia nervosa) and subthreshold disorders (disorders for which criteria encompass fewer symptoms than are required for any specific diagnoses in Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, specifically other depressive disorder, probable alcohol abuse or dependence, and somatoform and binge eating disorders). This questionnaire will be mainly treated to control our findings for confounding mental health status. | up to 15 min | |
6. | Type D personality | Type D Personality Scale (DS14) [38] | The DS14 is a 14-item self-rating questionnaire that consists of two 7-item subscales that are designed to measure personality traits of negative affectivity (NA) and social inhibition (SI), Each item is rated on a five-point Likert-type scale from 0 (false) to 4 (true) with scores ranging from 0 to 28 on each subscale. Scores equal or greater than 10 on both DS14 subscales of NA and SI, indicate Type D personality. | Up to 5 min |
7. | Compulsive Personality | Compulsive Personality Assessment Scale (CPAS) [39] | The CPAS includes 8 items and measures the severity of obsessive-compulsive personality traits and tendencies. Each of the eight diagnostic criteria is scored on a Likert scale of 0 to 4, and the maximum total score of the CPAS is 32. Diagnosis of obsessive-compulsive personality disorder can be defined as a score of three (severe) or four (very severe) on at least four of the CPAS items. | Up to 3 min |
8. | Cognitive function | Cambridge Neuropsychological Test Automated Battery [40] | CANTAB will be used to evaluate alterations in executive function as follows: - Motor screening Task (MOT) – sensorimotor function. - Cambridge Gambling Test – decision making (impulsivity, risk taking) - Delayed Matching to Sample – short-term visual recognition memory; - Intra-Extra Dimensional Set Shift (IED) – set-shifting, mental flexibility; - Match to Sample Visual Search (MTS) – attention and visual searching; - One Touch Stockings (OTS) – spatial planning and the working memory; - Rapid Visual Information Processing (RVP) – sustained attention; - Spatial Working Memory (SWM) – working memory. Tests have been validated in behavioral and psychopharmacological studies on healthy volunteers and in a range of patient groups [41]. | up to 60 min |
9. | Hemodynamic parameters | A long-term blood pressure (BP) device – The SOMNOtouch NIBP monitor | The SOMNOtouch NIBP monitor will be used to make a simultaneous, continuous, and non-reactive recording of BP, ECGs, and oxygen saturation thus a comparative analysis of several vital parameters will be provided. A long-term BP monitor will be placed on the patient at the beginning of the study. | Up to 24 h |
10. | Mood | Visual Analog Scales (VAS) [42] | Participants simply will rate the intensity of the sensation on a scale from 0–100. VAS were chosen based on its applicability in experimental clinical studies. | Up to 1 min |
11. | Cold pressure stress | Cold pressure test (CPT) [43] | CPT will be used to induce acute stress. Temperature and other environmental stressors are known to affect BP and heart rate. In this activity, participants will be performed the cold pressure test to demonstrate the changes in BP that follow an environmental stress. For cold stress, the subject will immerse his or her right hand in the ice-water bath (4 °C) to a point just above the elbow for 2 min. BP measurements will be obtained using a long-term BP device – the SOMNOtouch NIBP monitor on the wrist of the left hand at 0, 1, 2, and 4 min after the right hand will be removed from the ice-water bath. | Up to 8 min |
12. | Pain intensity | Visual Analog Scales (VAS) [42] | After the CPT, study participants will be debriefed about the purpose of the study and the subjective measure of perceived efforts and perceived difficulty of the CPT will be collected by using VAS. The scales ranged from 0 (maximum difficulty/efforts) to 100 (minimum difficulty/efforts). VAS were chosen based on its applicability in experimental clinical studies and common use in combination with CPT [44]. | Up to 1 min |