Premenopause
Conditions
Interventions
The present study is a Randomized Controlled Trial. A total of 68 women aged between 40 and 60 years who present symptoms suggestive of Climacteric Syndrome, according to the Kupperman Menopausal Inde
H02.004
Sponsors
Universidade Federal da Fronteira Sul
Universidade Federal da Fronteira Sul
Eligibility
Sex/Gender
Female
Age
40 Years to 60 Years
Inclusion criteria
Inclusion criteria: Women aged between 40 and 60 years; presence of symptoms suggestive of climacteric syndrome such as hot flashes, night sweats, menstrual irregularities, mood swings, sleep disorders, reduced libido; agreement to voluntarily participate in the research after receiving detailed information and signing the Free and Informed Consent Form; availability to participate in acupuncture sessions; comply with the proposed assessments; not using hormone therapy in the last 6 months
Exclusion criteria
Exclusion criteria: Pregnancy or suspected pregnancy during the study period; history of serious psychiatric disorders; presence of dermatological diseases in the area of ??application of the needles; history of bleeding disorders; participation in other simultaneous clinical trials; use of hormonal therapy in the last 6 months; other interventions for climacteric syndrome during the study period; extreme aversion to needles or previous adverse events related to this practice; diagnosis or suspicion of Cancer. Autoimmune diseases. Endocrinopathy (except controlled diabetes mellitus). Severe heart disease and uncontrolled arterial hypertension. Total hysterectomy or bilateral oophorectomy; performance of acupuncture in the last 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main outcome of this study focuses on measuring the intensity of climacteric symptoms presented by the participants and the effects after the intervention with acupuncture. To do this, it will be used the Kupperman Menopausal Index, developed by Robert A. Kupperman and his colleagues in 1953 and translated into Portuguese, as it is a recognized scale regarding climacteric symptoms (Melo, et al., 2016). The Kupperman Menopausal Index (KIM) is an instrument that involves eleven symptoms or complaints (vasomotor symptoms, insomnia, paresthesia, nervousness, melancholy, vertigo, weakness, arthralgia/myalgia, headache, palpitation and tinnitus). Each of them is assigned different scores according to their intensity and prevalence. The total score allows the symptoms to be classified as mild (values ??up to 19), moderate (between 20 and 35) or intense (greater than 35) | — |
Secondary
| Measure | Time frame |
|---|---|
| As secondary outcomes, in order to offer a more detailed and complete analysis of the effects of acupuncture in this specific population, areas such as quality of life, sleep quality, subjective response to pain and participant satisfaction will be evaluated. This approach allows identifying the possible therapeutic impacts of acupuncture in the context of the menopausal transition, and to this end, the SF-36 questionnaire, translated into Portuguese, will be used. | — |
Countries
Brazil
Contacts
Public ContactKeli Marocco
Universidade Federal da Fronteira Sul
Outcome results
None listed