Skip to content

Acupuncture to treat the symptoms of Premenstrual Syndrome - randomized controlled study

Acupuncture as a therapeutic resource for treatment of symptoms of Premenstrual Syndrome - a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5s4czx
Enrollment
Unknown
Registered
2018-05-16
Start date
2018-06-01
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

Menstruation Disturbances, Women

Interventions

GROUP A (experimental) - 15 women will receive the intervention of the acupuncture application in the specific acupoints (BP-6, BP-10, E-30, F-3, IG-4, P7, R-3, R-7
VC-12, VC-17, and Yintang) for the treatment of symptoms of premenstrual syndrome. The needles will remain for 30 minutes. There will be 12 treatment sessions once a week (3 months of intervention).
Luozhen
GB-20, VG-16, TA-14, and MT-15), unrelated to the premenstrual syndrome. The needles will remain for 30 minutes. There will be 12 treatment sessions once a week (3 months of intervention). After the e
Other
H02.004

Sponsors

Universidade de Mogi das Cruzes
Lead Sponsor
Universidade de Mogi das Cruzes
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Will include women aged between 18 and 40 years; presence of at least one physical symptom and one emotional symptom in the pre-menstrual and/or menstrual period observed in the two cycles prior to the study in non-users or users of oral contraceptives and who present three regular menstrual cycles before the study.

Exclusion criteria

Exclusion criteria: Women who use anxiolytics or antidepressants will not be included; with liver diseases; carriers of coagulation disorders, oophorectomized; carriers of cancer or serious diseases; carriers of psychiatric illnesses; history of radiation therapy or chemotherapy; illicit drugs and/or excessive alcoholic beverages, pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Presentation of the expected outcome 1: it is expected that acupuncture to reduce the percentage (%) of physical symptoms (edema in the hands and feet, breast tenderness and swelling, headache, pelvic discomfort, mood changes, feeling of weight gain, changes in bowel habit, sexual desire and lack of energy / tiredness / weakness). The evaluation of these symptoms will be performed through a specific questionnaire. This evaluation will be performed in 4 moments (initial, 2nd month, 3rd month, end of intervention).;Presentation of the expected outcome 2: It is expected that acupuncture to reduce the percentage (%) of emotional symptoms (depression, anxiety, anger / irritability, sadness / crying crises, and aggressiveness). The evaluation of these symptoms will be performed through a specific questionnaire. This evaluation will be carried out in 4 moments (initial, 2nd month, 3rd month, final).

Secondary

MeasureTime frame
Presentation of the expected secondary outcome 1: It is expected that acupuncture reduces the daily premenstrual symptoms. The symptoms will be evaluated by the Penn Daily Symptom Report. The scale evaluates the menstrual period, and the symptoms presented on each day of the month and will be graded according to the Likert scale (0-4). It will also note the use of medication for symptom relief. This evaluation will be carried out in 4 moments (initial, 2nd month, 3rd month).;Presentation of the expected secondary outcome 2: It is expected that acupuncture reduces pain intensity (when present). The intensity of the pain will be evaluated by the Visual Analog Scale. The evaluator should question the patient about their degree of pain with 0 (zero) meaning total absence of pain and 10 (ten) the maximum pain level that the patient can bear. This evaluation will be carried out in 4 moments (initial, 2nd month, 3rd month, final).;Presentation of the expected secondary outcome 3: It is expected that acupuncture improves the quality of life of women with premenstrual tension syndrome. The quality of life will be assessed by the WHOQOL-Bref questionnaire on different aspects of the participant's life: on physical health, emotional life, relationship with friends and family, and their environment. In order to analyze the life profile of the participants. The classification is: needs to improve (1 to 2,9); regular (3 to 3.9); good (4 to 4.9) and very good (5). This evaluation will be carried out in 4 moments (initial, 2nd month, 3rd month, final).

Countries

Brazil

Contacts

Public ContactFatima Fitz

Universidade de Mogi das Cruzes

fanifitz@yahoo.com.br+55011999651084

Outcome results

None listed

Source: REBEC (via WHO ICTRP)