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Auriculotherapy in improving sleep quality in people living with HIV

Efficacy of auriculotherapy in improving sleep quality in people living with HIV: a randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-34tsc8m
Enrollment
Unknown
Registered
2022-03-09
Start date
2022-01-24
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Auriculotherapy

Interventions

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
E02.190.204

Sponsors

Universidade Federal do Ceará
Lead Sponsor
Universidade Federal do Ceará
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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).

Countries

Brazil

Contacts

Public ContactAne Ramalho

Universidade Federal do Ceará

anekellylr@gmail.com+5585999748962

Outcome results

None listed

Source: REBEC (via WHO ICTRP)