Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Pain Acceptance |
The Acceptance & Action Questionnaire (AAQ-II) is a self-report questionnaire of seven items and aims to measure experiential avoidance. The answers are arranged on a seven-point Likert scale, in which 1 corresponds to "never true" and 7 to "always true". The final scores range from 10 to 70 points, with low scores corresponding to greater acceptance and ability to act in the presence of difficult thinking and emotions. |
Change from Baseline in AAQ-II at 6 months |
|
| Secondary |
Renal disease and quality of life |
The Kidney Disease Quality of Life - Short Form (KDQOL-SF) is a self-reported measure that assesses the functioning and wellbeing of people with kidney disease and on dialysis. This scale is divided in 4 domains: Your Health, Kidney Disease, Effects of kidney disease on your daily life and Satisfaction with treatment. The scores on each dimension range from 0 (worst) to 100 range (better). |
Change from Baseline in KDQOL-SF at 6 months |
|
| Secondary |
Depression, anxiety and stress |
The Depression, Anxiety and Stress Scale DASS-21 is a self-report scale containing three subscales scored in a four-point Likert format, ranging from 0 ("Strongly Disagree") to 3 ("Strongly Agree") in increasing order of symptom severity and frequency. Each subscale of the DASS consists of seven items that assess the states of depression (range 0-21), anxiety (range 0-20) and stress (range 0-21), where higher scores are indicative of higher levels of psychological distress. |
Change from Baseline in DASS-21 at 6 months |
|
| Secondary |
Interest in Mindfulness |
Analogue scale of interest in mindfulness where participants must fill in a scale of 1 to 10, how much they are interested in mindfulness practices, where 1 corresponds to "I am not at all interested" and 10 corresponds to "I am very interested". |
Change from Baseline in Interest in Mindfulness at 6 months |
|
| Secondary |
Level of Mindfulness |
The Five Facet Mindfulness Questionnaire (FFMQ) is a self-report scale that measures the level of Mindfulness through a multidimensional evaluation of its five facets: non-reactivity to inner experience, observe, act with awareness, describe and not judgment of inner experience. It includes 39-items that are rated on a 5-point Likert-type scale ranging from 1 (never or very rarely true) to 5 (very often or always true), with higher scores indicating higher levels of mindfulness skills. |
Change from Baseline in FFMQ at 6 months |
|
| Secondary |
Pain Profile |
The Profile of Chronic Pain: Screen (PCP:S) is a self-report scale with fifteen items that allow the rapid identification of the pain experience on a multidimensional level of an individual. It is divided into three dimensions: frequency and intensity of pain (four items; score from 0 to 30), interference of pain in daily activities (six items; score from 0 to 36) and effect of pain on emotions (five items; score from 0 to 25). It guides patients to assess the frequency of any pain, average pain, severity, and the highest pain intensity over the past 6 months. |
Change from Baseline in PCP:S at 6 months |
|
| Secondary |
Self-Compassion |
The Self-Compassion Scale (SCS) is a self-report questionnaire that includes three basic components: self kindness (extend gentleness and understanding to self rather than self-criticism), ordinary humanity (see your experience as a part of the human experience, rather than being isolated) and Mindfulness (not over-identification with thoughts and more painful feelings). The answers are given on a likert scale (1- "almost never" to 5 "almost always"), when the answers are not compassionate they must be calculated inversely. |
Change from Baseline in SCS at 6 months |
|
| Secondary |
Biological markers |
Plasma concentrations of inflammatory markers (C-reactive protein and interleukin 6) will be measured. |
Change from Baseline in C-reactive protein and interleukin 6 at 6 months |
|
| Secondary |
Inquiry of the Mindfulness Practice |
In each mindfulness session, after the practices, an inquiry will be carried out focused on the participant's described experience, where one describes bodily sensations, emotions and thoughts perceived during the practice. This description is made from the investigation of the mindfulness instructor. |
During the 8 weeks of Intervention |
|
| Secondary |
Interviews |
Interviews will be carried out with participants of the studied phenomenon or with key informants who know about the phenomenon or context researched. Conducted individually and semi-structured based on a script designed to ensure coverage of the investigated indicators. |
During the 8 weeks of Intervention and after intervention |
|
| Secondary |
Feasibility of the Hemomindful Program |
Retention to the study protocol will be assessed using the primary data of all participants at the beginning of the study.
The adherence to the Hemomindful Program, implementation, security, and satisfaction of the treatment will be assessed through all the participants of the Intervention Group. |
During the 8 weeks of Intervention and after intervention |
|
