Evaluation of auriculotherapy associated with standard treatment in diabetic patients

Authors
Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2021
INTERVENTION: E02.190.044.133 The intervention will be carried out by professionals trained and trained to apply the protocols. Standard treatment (tp): includes orientation, medication in use and change of habits. 200 participants will be recruited (randomized into 4 groups of 50). Experimental groups: Auriculotherapy – (1) right ear pinna (PA) associated with tp (ADtp); (2) left PA associated with tp (AEtp); (3) alternating the laterality of the PA associated with the tp (AAtp), starting with the right and ending with the left. In these groups, roasted mustard seeds will be used, fixed with microporous tape in the ear points of the kidney, liver, stomach and small intestine, in association with the tp. Participants will be instructed to apply pressure with their fingers on the seeds, until they feel a slight pain and sustain the pressure (10 sec each point), repeating the procedure after the main meals (4 times a day). (4) False Auriculotherapy Group associated with tp (AStp) ‐ only microporous tape, without seeds, will be used, fixed in the same auricular points, but without pressure stimulation. CONDITION: Depressive episodes; non‐organic sleep disorders due to emotional factors PRIMARY OUTCOME: Evaluation of the quality of life of volunteers, using the SF‐36 questionnaire, before, at the end of treatment and after two months of the last treatment. Glucose verification, through the evaluation of capillary blood glucose with the use of strips that make electrical capture of the hemoglobin drop (Glycated Hemoglobin), before, at the end of the intervention and after two months. SECONDARY OUTCOME: Assessment of adherence to standard treatment using a questionnaire to identify how the individual is using the medication periodically. The evaluation will be carried out before, at the end of treatment and after two months of the last treatment. Assessment of mood disorders through the reduced version of the Depression, Anxiety and Stress Scale (DASS‐21). The evaluation will be carried out before, at the end of treatment and after two months of the last treatment. Evaluate the amount of plasma intracellular adhesion molecule through specific kits, before, at the end of treatment and after two months of the last treatment Evaluation of pro‐inflammatory cytokines (IL‐1beta, IL‐6 and TNF‐alpha), using specific kits. The evaluation will be carried out before, at the end of treatment and after two months of the last treatment. Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI‐BR). The PSQI‐BR assesses sleep quality over the last month. The evaluation will be carried out before, at the end of treatment and after two months of the last treatment. To assess the mobility and functional balance of individuals with T2D, the Timed Up and Go (TUG) test will be used. This test quantifies functional mobility in seconds through the time the individual performs the task of getting up from a chair. The evaluation will be carried out before, at the end of treatment and after two months of the last treatment. INCLUSION CRITERIA: Age 18 years or older diagnosed with Type 2 Diabetes Mellitus
Epistemonikos ID: 6e35a03cf5f0137c8f253781411b1e37b8cb9a50
First added on: Aug 25, 2024