|drug4062||samling of oropharynx and nasopharynx Wiki||0.58|
|drug152||Active Comparator: Self-care group Wiki||0.58|
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|D001008||Anxiety Disorders NIH||0.09|
There are 3 clinical trials
On 12 January 2020, the World Health Organization (WHO) confirmed that a novel coronavirus was the cause of a respiratory illness in a cluster of people in Wuhan City, Hubei Province, China, which was reported to the WHO on 31 December 2019. There is evidence of a high prevalence of psychiatric comorbidities in Fibromyalgia (FM )(especially depression, anxiety, post-traumatic stress disorder), which are associated with a worse clinical profile. In these challenging times of COVID-19, anxiety increased among the general population. Fibromyalgia patients are more at risk of developing anxiety in these difficult times. This might result in more frequent visits to the rheumatology clinics with an exacerbation of their chronic pain syndrome.
Description: Number of FM patients in the rheumatology outpatient clinics during the COVID-19 lockdown period (2020)Measure: Number of FM patients Time: two months
The investigators planned to analyze the effect of Covid-19 fear and anxiety on the daily life, sleep quality and depression-anxiety levels of fibromyalgia patients.
Description: It is evaluated by the Coronavirus anxiety scale (CAS). It was developed by Lee et al. and Evren et al. were made validity and reliability of this scale in Turkish. It is 5-items scale, and each item scores between 0-4. The total score (ranging from 0 to 20) is calculated by adding up each item score. The higher the score, the greater the anxiety associated with coronavirus-19. Level of Covid-19 anxiety will be compared between fibromyalgia and control groups.Measure: Level of Covid-19 anxiety Time: 15 seconds
Description: It is evaluated with The Fear Covid-19 Scale which was developed by Ahorsu et al., and it was adapted into Turkish. It is 7-item scale, each item scores with 5-pont Likert scale. Total score is 35, and the higher score describe higher fear level. Level of Covid-19 fear will be compared between fibromyalgia and control groups.Measure: Level of Covid-19 fear Time: 15 seconds
Description: The daily life of fibromyalgia patients will be analyzed with Fibromyalgia Impact questionnaire (FIQ). It has 21 individual questions. All questions are based on an 11-point numeric rating scale of 0 to 10. It is divided three domains: function, over impact, symptoms. The summed score for function (range 0 to 90) is divided by 3, the summed score or overall impact (range 0 to 20) is not changed, and the summed score for symptoms (range 0 to 100) is divided by 2. The total score is the sum of the three modified domain scores, and total score ranges from 0 to 100. Higher scores indicate worse daily life. Investigators will be analyzed the relationship between CAS, the fear Covid-19 Scale, and the FIQ.Measure: The Covid-19 anxiety and fear levels on daily life the patients with fibromyalgia Time: 15 seconds
Description: The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. The sum of scores for these seven components yields one global score.The total score ranges from 0-21. A total score greater than 5 indicates "poor sleep quality" Investigators will be analyzed the relationship between CAS, the fear Covid-19 Scale, and the PSQI.Measure: The Covid-19 anxiety and fear levels on sleep quality the patients with fibromyalgia Time: 15 seconds
Description: The anxiety and depression level will be evaluated with Hospital anxiety-and depression scale (HADS).The purpose of the scale is not to make a diagnosis. The scale is a self-report scale and consists of 14 questions, 7 of which investigate depression, and 7 of which investigate anxiety of patients.Measure: The Covid-19 anxiety and fear levels on anxiety-depression the patients with fibromyalgia Time: 15 seconds
This study is a randomized, single-blinded, parallel, superiority, controlled trial. The main objective is to verify the effects of a telehealth stretching exercise program on pain, depression, sleep parameters and functionality of women with fibromyalgia, during the Covid-19 pandemic. Participants will be women with primary fibromyalgia, seen at public and private health services, in the city of Pelotas (south of Brazil). Participants will be recruited through social networks, newspapers and support from the National Association of Fibromyalgia and Correlated Diseases (Anfibro). Eligible participants will be randomized, stratified by age (30 to 45; 46 to 60), and allocated to one of the two groups, experimental or control. The experimental group will receive a telehealth stretching exercise program twice a week (guided by a professional) and counseling guide to stretching exercises with explanatory video regarding the execution of the protocol proposed by the guide. The total duration of exercise program will be 40 minutes (will be 12 exercise, 3 sets of each stretching for 10 seconds, carried out individually by a video call application - WhatsApp). The control group will receive only counseling guide to stretching exercises with explanatory video regarding the execution of the protocol. Both interventions will last 12 weeks, with outcomes evaluations in three moments: baseline (week 0), midpoint (week 6) and after the intervention (week 13). The following outcomes will be evaluated: generalized index of pain, fatigue and severity of symptoms, depression, level of physical activity, functionality, quality of life and sleep. All outcomes will be evaluated by questionnaires self-completed, that will be answered on Google Docs by video call, with exception of functional test that will be applied by video call. The study's hypothesis consists of improving outcomes for both groups, but with superiority for the experimental group.
Description: A generalized pain index is a tool used to measure the amplitude of patients' clinical symptoms with fibromyalgia. It is considered a diagnostic scale, presenting 90.8% accuracy about the American College of Rheumatology's first criteria, de1990 and validated by the same institution in 2010 (WOLFE et al., 2010) being recognized by the Brazilian Society of Rheumatology - SBR, in 2017. Comprises the body areas usually affected by the disease, where the patient indicates if he felt pain at that moment in the last seven days (HEYMANN et al., 2017). Scores considered high are higher than 7. It will be checked if there was a change in painful behavior through collections in three periods of time, which will be compared at the end of the treatment.Measure: Changes in the Widespread Pain Index Time: Zero week, six week, and twelve week
Description: The Pittsburgh Sleep Quality Index Self-Report Questionnaire has been widely used to record sleep for four weeks. It includes 19 self-reported questions, divided into seven domains (HERNÁNDEZ et al., 2020) and five questions to be answered by the roommate, with questions about the noise produced during sleep. The score ranges from 0 to 3, where higher scores indicate worse sleep quality (BERTOLAZI et al., 2011). It was developed in 1989 by Buysse et al. and validated in the Brazilian version in 2011 by Bertolazi et al. (PASSOS et al., 2017). It is hoped to find a change in sleep quality; thus, three collections will be made, at different times of time, which will be compared at the end of the treatment.Measure: Changes in Sleep Quality Time: Zero week, six week, and twelve week
Description: Symptom Severity, based on analyzing the primary symptoms reported in fibromyalgia, such as fatigue, sleep, and cognition, is considered a diagnostic criterion, with a sensitivity of 90.9% and specificity of 85.9% (HEYMANN et al., 2017). It comprises four domains, with scores ranging from 0 to 3, and scores above five are considered relevant. Validated by the American College of Rheumatology in 2010 (WOLFE et al., 2010) and recognized by the Brazilian Society of Rheumatology - SBR, 2017.Measure: Symptom Severity Scale Time: Zero week, six week, and twelve week
Description: Fibromyalgia Impact Questionnaire (FIQ) is a survey that looks at the severity of the pathology on the individual's functional capacity and the perception of the quality of life. Their scores range from 0 to 100, where higher values indicate a more significant disease impact. Scores are expressed as follows: from 0 to 38 mild effect, from 39 to 58 moderate effect, and from 59 to 100 severe impact (UMAY et al., 2019) and validated in 1991 by Burckhardt et al., Translated and adapted for the Brazilian version in 2006, by Marques et al. (MARQUES et al., 2006).Measure: Impact of fibromyalgia on daily activities Time: Zero week, six week, and twelve week
Description: Beck's Depression Inventory (BDI) is a tool whose purpose is to analyze the perception of depressive symptoms, developed and revised in 1996 by Becket al., And validated in the Brazilian version in 2012, by Gomes-Oliveira et al. (GOMES- OLIVEIRA et al., 2012). It includes 21 items, with scores ranging from 0 to 3, where the maximum score is 63, indicating severity. Values between 0 and 13 show minimal symptoms, 14 to 19 medium symptoms, 20 to 28 moderate, and 29 or more indicate severe depression (ALVENTOSA et al., 2020). Among the issues investigated there are feelings of sadness, failure, dissatisfaction, pessimism, self-judgment, distorted body vision, tiredness, lack of appetite, constant concerns, difficulty in work activities, and loss of libido (ANDRADE et al., 2020).Measure: Depressive symptoms Time: Zero week, six week, and twelve week
Description: The participants' physical activity levels will be measured using the International Physical Activity Questionnaire - IPAQ-C, in its short version, including eight self-administered questions, in different domains such as work, leisure, domestic activities, and physical exercise. The data expressed in minutes, with the metabolic equivalent calculated (1 MET: 3.5 ml/kg/min). As with other questionnaires, we will apply it in electronic format, already tested and proven by previous studies (PIRES et al., 2014). Proposed and validated by the World Health Organization in 1998, it had its Brazilian version in 2001, through the study by Pardini et al. (PARDINIA et al., 2001).Measure: Physical activity level Time: Zero week, six week, and twelve week
Description: Flexiteste is a tool developed by Araújo and Pavel in 1986 to analyze the flexibility of twenty articular movements of the human body (SALVADOR et al., 2010). Passively performed, with the examiner's aid up to the maximum joint amplitude, will adapt it for the online format, done in an active-assisted way, where the examined person assists the top angle, with the help of the opposite upper limb, with scores from 0 to 4. Higher values indicate increased mobility (ARAÚJO, 1986). The investigator masked will guide the patient's position remotely throughout the test.Measure: Functionality / Flexibility Time: Zero week, six week, and twelve week
Description: Pain intensity will be analyzed using the Visual Analog Pain Scale - VAS, which comprises values from 0 to 10, where 0 corresponds to "no pain" and 10 "means the greatest pain imaginable" (HERNÁNDEZ et al., 2019). Being a unidirectional scale allows measuring the pain felt at the test's exact moment (MARTINEZ et al., 2011). The project will be used to check the pain at rest and right after the execution of a movement, aiming to understand the pain behavior before the proposed activity, in three moments: week 0, week six, and week 13. The associated test will elevate the upper limbs, with the hands splayed upwards and the fingers intertwined, using three sustained series of ten seconds, to be performed, together with the examiner's online presence. The EVA will be shown to the participant before the exercise and immediately after.Measure: Painful intensity at rest and movement Time: Zero week, six week, and twelve week
Description: Will analyze the subjective perception of well-being through a simple question, "in your opinion, how much did participation in the project improve your feeling of general well-being," with structured responses based on the 5-point Likert Scale, varying from "dissatisfied" to "very satisfied." The same will be applied to the two groups in the same format as the questionnaires previously mentioned, through Google Docs, with a link to be made available on a scheduled date and time, through the WhatsApp application.Measure: Subjective perception of well-being Time: Twelve week
Data processed on January 01, 2021.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports