Auriculotherapy in improving sleep quality in people living with HIV

Not Applicable

Recruiting

• Conditions: Auriculotherapy; HIV; Sleep Initiation and Maintenance Disorders; C01.221.250.875.040

• Registration Number: RBR-34tsc8m
• Lead Sponsor: niversidade Federal do Ceará

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-09
• Last Update Posted: 29 May 2023
• Study Completion: 2023-07-31

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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 et al., 2011; FONSECA et al., 2010; ; KONRAD 2005); Availability for face-to-face return on the 8th and 15th days of the beginning of the intervention, and telephone assessment on the 22nd and 29th days of the intervention; Have your own landline or cell phone.

Exclusion Criteria

Patients with disabling mental illness; pregnant women; Homeless people and those deprived of their liberty in penitentiaries; Dermatological lesion at the site of the auriculotherapy points of the study; Allergy to the material used in the intervention.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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).