Authors
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Universidade Federal de São Paulo -More
Category
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Primary study
Registry of Trials»Brazilian Registry of Clinical Trials
Year
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2023
INTERVENTION: E02.190.888.124 The patients were randomized (aleatory) and divided into two groups: GETA (Art therapy study group) ‐ intervention group (n=21), and GDA (Random drawing group) ‐ controlled group (n=15). The protocols from both groups were 16 sections. The participants were evaluated in fourth different times (one week before the beginning of the therapeutical process, one week after sixteen sections, and si Xand twelve months after the beginning of the process. Fahn‐Tolosa‐Marin Rating Scale was a double‐blinding used to evaluate the Essential tremor signs. The World Health Organization Quality of Life‐Brief scale assesses the quality of life features. Beck Anxiety Inventory and Beck Depression Inventory were used to assessing symptoms of anxiety and depression. Medical painting therapy consists of an artistic therapeutic process, in which the patient makes charcoal works and paintings with watercolor. This therapeutic process includes a diagnosis phase and the development of acquiring artistic elements in relation to the principles of light, color, and darkness. The control group developed creative tasks sequence. (It consisted of free draws, coloring mandalas, and observing and drawing nature elements). CONDITION: C10.228.662 Essential Tremor PRIMARY OUTCOME: Expected outcome 1; To evaluate the effects of medical painting therapy, and its durability, in volunteers with essential tremor. The primary outcome expected is the diminishing of essential tremor signs and symptoms regarding to the location and severity of the tremor, the motor tasks, and the functionality of the daily activities of the volunteer. ; Is expected that the results happen after the intervention process of the art therapy, as well as after one year of the beginning of the protocol. ; The scale Fahn‐Tolosa‐Marin is used to evaluate the primary outcomes at four different times.; ; Outcomes achieved 1; The results showed the p‐values of the correlation between the first and second evaluations (after 16 sections of the therapeutic process). Using Fahn‐Tolosa‐Marin Rating Scale, we observed that the Essential tremor signs of Geta participants have decreased in location and severity, motor tasks, and functionality. The value of p < 0.05 was the parameter used to consider the results with statistical significance.; ; INCLUSION CRITERIA: Min age 18 years; both genders; diagnosed with Essential Tremor; without cognitive impairment; authorized signature of the free and consent form SECONDARY OUTCOME: Expected outcome 1 ; The first secondary outcome expected was the enhancement of the quality of life in the Physical, Psychological, Social relationship, and Environment domains. It is expected that the improvement will happen after the intervention process (16 sections) of the art therapy, and after one year of the beginning of this trial protocol. The World Health Organization Quality of Life‐Brief Version scale is used to evaluate the Quality of life domains. The p‐value < 0.05 was a parameter used to consider the statistical significance results. ; Expected outcome 2 ; Expected the diminishing of anxiety symptoms. Was estimated that the improvement remained after the intervention process of medical painting therapy (16 sections), and one year of the beginning of this trial protocol. The Beck Anxiety Inventory was used to evaluate anxiety symptoms. The p‐value < 0.05 was a parameter used to consider the statistical significance results. ; Expected outcome 3 ; Expected the diminishing of depression symptoms. Was estimated that the improvement of Geta, remained after the intervention process of the art therapy (16 sections), and one year of the beginning of this trial protocol. The Beck Depression Inventory was used to evaluate depressive symptoms. The p‐value < 0.05 was a parameter used to consider the statistical significance results. Outcomes achieved 1 ; The GETA showed an increment in quality‐of‐life domains between the first and second (after 16 sections) evaluations, and the first and fourth evaluations (after one year of the beginning of this trial). The p‐value < 0.05 was a parameter used to consider the statistical significance results presented. ; ; ; ; Outcomes achieved 2 ; The Geta showed a diminishing of anxiety symptoms when compared to the scores achieved between the first and the second (after 16 sections) evaluations, and the first and fourth evaluations (after one year of the beginning of this trial). The scores of the total sum and the qualifiers from the Beck Inventory presented statistical significance. ; ; ; Outcomes achieved 3 ; The Geta showed a diminishing of depression symptoms when compared to the scores achieved between the first and second evaluations (after 16 sections), and the first and fourth evaluations (after one year of the beginning of this trial). The Gda reached a diminishing of the symptoms also with statistical significance scores. ;
Epistemonikos ID: 8315ca1ccc6a37353dcd562b7757ebdadca12cef
First added on: Feb 20, 2024