Authors
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Universidade Federal do Ceará -More
Category
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Primary study
Registry of Trials»Brazilian Registry of Clinical Trials
Year
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2022
INTERVENTION: E02.190.204 Auriculotherapy, with mustard seeds, in people living with HIV (PLHIV) with sleep disorders (scores greater than 10 on the Pittsburgh Sleep Quality Index). The sample size needed to satisfy the above requirements was calculated at 82 participants in each treatment group, ie, a total of 164 patients. To this value, 20% was added to cover eventual losses to follow‐up, so that the final sample size was estimated at 99 participants in each group, corresponding to a total of 198 participants. The protocol will have three steps. 1. Pre‐Intervention and Randomization: If the participant has scores greater than 10 on the PSQI‐BR, the Sociodemographic, Epidemiological and Clinical Form for PLHIV, Pittsburgh Sleep Quality Index (PSQI‐BR), Severity Index of Insomnia (IGI), Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI) and Quality of Life Assessment Instrument for PLHIV (WHOQOL‐HIV‐Bref), with randomization to intervention or control groups. 2. Intervention: the intervention group will receive auriculotherapy with mustard seeds at 6 points: neurasthenia, neurasthenia area, anxiety, heart, Shen Men and occiput, with instructions to press them 3 times a day for 30 seconds. After the 1st session, two more face‐to‐face sessions will take place on the 8th and 15th days, with reapplication of the PSQI‐BR and IGI instruments. The control group will receive microporous adhesives at the same points, will have the same face‐to‐face returns, but without the use of seeds and without pressure on the places. On the 22nd day, a telephone call will be made to both groups and PSQI‐BR and IGI will be reapplied, and everyone will be instructed to remove the micropores and mustard seeds. 3. Post‐intervention: volunteers from both groups will be evaluated by telephone on the 29th day, t CONDITION: Auriculotherapy; HIV; Sleep Initiation and Maintenance Disorders C01.221.250.875.040 PRIMARY OUTCOME: Improvement in Pittsburgh Sleep Quality Index (PSQI‐BR) scores (leaving the condition of having a sleep disorder), so the effectiveness will be proven through the reduction of these scores. SECONDARY OUTCOME: Improved scores on the Insomnia Severity Index (ISI), Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI) and the Quality of Life Assessment Instrument for people living with HIV (PLHIV (WHOQOL‐HIV‐Bref). INCLUSION CRITERIA: People living with HIV (PLHIV) aged 18 or over, of both sexes; On antiretroviral therapy (ART) for at least three months, a period stipulated based on the time the patient needs to adapt to the medication. According to the literature, from the first month onwards, initial adverse events are minimized, as in the case of the use of Efavirenz (EFV), which has acute effects on the central nervous system in up to 50% of patients in the first week of treatment, such as : dreams, nightmares, sadness, irritability, nervousness, dizziness and difficulty sleeping (NGUYEN et al., 2011; WATERS et al., 2011; SCOURFIELD et al., 2012; OSHINAIKE et al., 2014; ALLAVENA, 2015). Other antiretroviral drugs can also cause sleep disorders, such as Zidovudine (AZT), Stavudine (d4T), Lamivudine (3TC), Indinavir (Crixivam) (BRASIL, 2004); Complaints of poor sleep quality, confirmed by the Pittsburgh Sleep Quality Index (PSQI‐BR), with scores greater than 10 (BUYSSE et al.; 1989; BERTOLAZI e
Epistemonikos ID: 182535414e6821aa5b66262ae49b2f2bedaa738e
First added on: Aug 25, 2024