EFFECTS OF A FULL SPECTRUM CANNABIS EXTRACT WITH DIFFERENT DOSES OF CBD AND THC ON THE MODULATION OF FIBROMYALGIA: A PILOT, MULTICENTER, OPEN LABEL CLINICAL TRIAL (FRIDINHA)

It is a 21-item multiple-choice questionnaire that can be self-administered or administered by a researcher. This instrument aims to measure the impact of fibromyalgia on functional capacity, professional situation, psychological disorders, and physical symptoms. Its score is directly proportional to the impact of this pathology on quality of life and daily functioning, that is, the higher the score obtained, the worse the quality of life and the more compromised the patient's functioning.The score is: 0 good - 100 very bad

A questionnaire consisting of 10 varied open-ended and multiple-choice questions that can be self-administered or administered by a researcher, aims to measure sleep quality and disorders. Its score is tabulated as follows: 0-4 good sleep quality, 4-10 poor sleep quality, and >10 presence of sleep disorder. This instrument will be applied at times T0 to T180.

A 36-item multiple-choice questionnaire that can be self-administered or administered by a researcher. Its main objective is to measure the impact of a certain pathology on the patient's quality of life, assessing both positive and negative aspects of health. It is scored in eight functional domains, which cannot be added together or averaged, with results ranging from 0 (worst quality of life) to 100 (best quality of life)

A 48-item multiple-choice questionnaire to be administered by a researcher aims to create a method for accessing and understanding the impact of adverse effects during pharmacological treatment. Its score is directly proportional to the impact of the pathology on the patient's quality of life and daily functioning.The score is: 0 good - 144 very bad

An 8-item questionnaire with dichotomous responses (yes/no), which can be self-administered or administered by a researcher, used to screen for risk of obstructive sleep apnea. Scoring is done by assigning 1 point for each "yes" answer, with a total score ranging from 0 to 8. Scores from 0 to 2 indicate low risk, from 3 to 4 indicate intermediate risk, and scores equal to or greater than five indicate high risk for apnea. The identification of patients with this disorder is essential in studies with medications that promote sleep, as these drugs can aggravate apnea and increase the risk of adverse events

A 17-item questionnaire that investigates whether there has been exposure to potentially traumatic events and how this occurred throughout life, in this sense, classifying the experience for each item as direct, witnessing, knowledge from third parties, or occupational exposure-in order to allow for different forms of contact for the same stressful event.This questionnaire is scored based on the sum of the items marked, with each item equivalent to 1 point. In addition, information can be extracted from the domains of accidental/injury trauma (items 1, 2, 3, 4, and 12), victimization trauma (items 6, 8, and 9), and predominant life-threatening trauma (items 5,7, 10, 11, 13, 14, 15, and 16). The score is: 0-68, higher scores = greater exposure to traumatic events.

It is a brief self-administered screening questionnaire composed of 6 yes/no items. This instrument is designed to help identify patients who may have fibromyalgia among individuals presenting with chronic widespread pain. The questions assess characteristic symptoms of fibromyalgia, such as diffuse pain, fatigue, sleep disturbances, and sensitivity to stimuli. The score corresponds to the number of positive responses, with higher scores indicating a greater likelihood of fibromyalgia.