Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Revised Fibromyalgia Impact Questionnaire (FIQR) |
The FIQR comprises three dimensions: physical dysfunction (scores from 0 to 30), overall impact (scores from 0 to 20), and intensity of the symptoms (scores from 0 to 50) is used to measure the impact generated by FM during the last week. It consists of 21 items, which are answered on a numerical rating scale of 11 points (from 0 to 10). Total scores can range from 0 to 100, with higher scores reflecting greater deterioration. |
Through study completion, an average of 9 months |
|
Secondary |
Tampa Scale for Kinesiophobia (TSK-11) |
TSK-11 is used to assess fear of pain and movement. It consists of 11 items, which are answered on a Likert scale of 4 points. Total scores of each scale range from 11 to 44, where higher scores indicate a greater fear of pain and movement. |
Through study completion, an average of 9 months |
|
Secondary |
Hospital Anxiety and Depression Scale (HADS) |
HADS is used to quantify the severity of anxiety and depression symptoms. It consists of two dimensions (anxiety and depression) of 7 items each responding on a Likert scale of 4 points. Total scores of each scale (HADS-A and HADS-D) range from 0 to 21, where higher scores indicate greater severity of symptoms. |
Through study completion, an average of 9 months |
|
Secondary |
Pain Catastrophizing Scale (PCS) |
PCS is used to evaluate catastrophic thoughts associated with pain. It consists of three dimensions (rumination, magnification, and helplessness) of 13 items in total, which are answered on a Likert scale of 5 points. Total scores on each scale range from 0 to 52, with higher scores indicating more catastrophic thoughts. |
Through study completion, an average of 9 months |
|
Secondary |
Perceived Stress Scale (PSS) |
PSS is used to evaluate the stress perceived by people during the last month. This study will use a 4 item version. The response format of this scale is 5-point Likert type. Total scores range from 0 to 16, with higher scores indicating greater perceived stress. |
Through study completion, an average of 9 months |
|
Secondary |
Personal Perceived Competence Scale (PPCS) |
PPCS is used to measure perceived competence. It consists of 8 items that are answered on a 6-point Likert scale. Total scores of each scale range from 8 to 48, with higher scores indicating greater perceived competence. |
Through study completion, an average of 9 months |
|
Secondary |
Rosenberg Self-Esteem Scale (RSES) |
RSES is used to measure self-esteem. It consists of 10 items that are answered on a Likert scale of 4 points. Total scores of each scale range from 10 to 40, where higher scores indicate higher self-esteem. |
Through study completion, an average of 9 months |
|
Secondary |
Cognitive Emotion Regulation Questionnaire (CERQ) |
CERQ is used to assess individual differences in the cognitive regulation of emotions. The instrument measures nine 2-item dimensions (self-blame, blaming others, acceptance, refocusing on planning, positive refocusing, rumination, positive reappraisal, putting into perspective, and catastrophizing). This study will use the short version of 18 items. Responses are given on a 5-point Likert scale ranging from 1 (almost never) to 5 (almost always). Total scores for each dimension range from 2 to 10, with the highest scores indicating the specific cognitive strategy most used. |
Through study completion, an average of 9 months |
|
Secondary |
Positive and Negative Affect Schedule (PANAS) |
PANAS is used to evaluate positive and negative affect. It consists of two dimensions (positive affect and negative affect) of 10 items each answered on a Likert scale of 5 points. Total scores of each scale range from 10 to 50, where higher scores indicate a greater presence of the specific affectivity. |
Through study completion, an average of 9 months |
|
Secondary |
Ecological Momentary Assessment (EMA) |
Use of a commercial app used to assess daily (four times a day) the level of pain, fatigue, pain catastrophism during the monitoring period. |
Through intervention completion, an average of 3 months |
|