CARINAE: A Digital Health Intervention for Stress Relief in Perioperative Care: Clinical Study

General Self-Efficacy Scale

Time Frame: 2 months: from baseline to 14 days after the surgery

Patient- and caregiver-reported questionnaire on self-efficacy perception. It consists of 10 items evaluated on a 1-4 Likert scale. Scores range from 10 to 40 amd higher scores indicate higher self-efficacy.

Visual Analog Scale for Stress

Time Frame: 2 months: from baseline to 14 days after the surgery

Patient and caregiver-reported visual analog scale question to assess subjective stress. Along a 100 mm horizontal line, patient and caregiver indicate their perceived stress intensity. Rating varies from 0 (minimum values) to 100 (maximum value). Ratings of 0 to 4 mm can be considered no stress; 5 to 44 mm, mild stress; 45 to 74 mm, moderate stress; and 75 to 100 mm, severe stress.

Visual Analog Scale for Pain

Time Frame: 2 months: from baseline to 14 days after the surgery

Patient-reported visual analog scale question to assess subjective pain. Along a 100 mm horizontal line, patient and caregiver indicate their perceived pain intensity. Rating varies from 0 (minimum values) to 100 (maximum value). Ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain.

The Short Warwick-Edinburgh Mental Well-Being Scale

Time Frame: 2 months: from baseline to 14 days after the surgery

Patient- and caregiver-reported questionnaire on mental well-being. It consists of 7 items and each item is answered using a 1-5 Likert scale. Scores range from 7 to 35 and higher scores indicate higher positive mental wellbeing.

The Positive and Negative Affect Schedule

Time Frame: 45 days: From hospital admission to 14 days after the surgery

Patient-reported questionnaire on emotional status. It consists of 20 items that describe n emotions of a positive or negative nature, 10 of them positive and 10 negative. Each item is answered using an Likert-tscale with 5 response options (not at all, very little, somewhat, quite a lot, very much). Scores can range from 10 - 50, with higher scores representing higher levels of positive or negative affect.

Hospital Anxiety and Depression Scale

Time Frame: 45 days: From hospital admission to 14 days after the surgery

Patient-reported questionnaire on anxiety and depression levels during the hospital stay. Hospital Anxiety and Depression Scale is a fourteen-item scale with seven items each for anxiety and depression subscales evaluated on a 0-3 Likert Scale. Rating varies from 0 to 21 and a subscale score \>8 denotes anxiety or depression.

Patient Activation Measure

Time Frame: 45 days: From baseline to hospital discharge

Patient-reported questionnaire on the level of activation. It consists of 13 items that have four possible response options ranging from (1) strongly disagree to (4) strongly agree, and an additional "not applicable" option. To calculate the total score, the raw score is divided by the number of items answered (excepting non-applicable items) and multiplied by 13. Then, this score is transformed to a scale with a theoretical range 0-100, based on calibration tables, with higher scores indicating higher patient activation. The raw scores can be converted into four activation levels: 1 (≤47.0) not believing activation important, 2 (47.1-55.1) a lack of knowledge and confidence to take action, 3 (55.2-67.0) beginning to take action and 4 (≥67.1) taking action.

Health-related Quality of Life - EQ-5D-3L/-Y

Time Frame: 45 days: From hospital admission to 14 days after the surgery

Patient-reported questionnaire on quality of life. The questionnaire consists of five items related each to one dimension: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems (1), some problems (2), and extreme problems (3). The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems. In addition, there is a visual analogue scale (VAS) to indicate the general health status with 100 indicating the best health status.