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IRCT20171104037220N2 IRCT 2020-06-28 Mashhad University of Medical Sciences Acupuncture and menopausal disorders control The comparison of the effect of acupuncture and drug therapy on controlling hot flash and sleep disorders in menopause women 2014-01-29 anticipated 82 Complete https://irct.ir/trial/48565 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Menopausal women who referred to the Gynecology Clinic of Imam Reza Hospital due to hot flashes and were eligible to participate in the study based on inclusion and exclusion criteria randomly assigned to intervention and control groups based on random block allocation with a block size of 2. Each block stratified based on the frequency of hot flushed per day (less than 7 times and more than 7 times) and age at menopause (younger than 45 years old and older than 45 years old). Random allocation performed by assigning the first subject based on the frequency of hot flush per day to intervention or control group and assigning it's pair based on frequency of hot flush to the other group. This method ensured the similar allocation number in the study groups. To protect patients' rights, if the subjects did not not like to continue acupuncture, they referred to the normal care. 3 Hot flash and sleep disorders. Intervention 1: Intervention group: Acupuncture performed three times a week, each session took last for 20 minutes. Intervention duration was 4 weeks. Acupuncture points determined based on traditional Korean medicine, including ST36, SP6, L14, PC6, HT7, HT8, and a point at the bottom of the CV4 abdomen. A total of 7 points selected to reduce hot flashes. Metal disposable needles used for the acupuncture in the mentioned points for 20 minutes. The length of the needles were 40 mm. The needles inserted 3-15 mm deep in the mentioned points. Intervention 2: Control group: Were received fluoxetine for 4 weeks and subjects were then be followed for 12 weeks. Yes - There is a plan to make this available What will be shared: The comparison of the effects of acupuncture and drug therapy on controlling the frequency and severity of hot flashes among menopausal women When: From now to 6 months later To whom: Midwives, Obstetricians and gynecologist and acupuncturists Conditions: Protocol and its results Where to obtain: Tahereh fathi Najafi How to obtain: The request will be sent by email Comments:
public Tahereh Fathi Najafi
Dr Mohamad Shahinfar University, Sarab Bazarche, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9179734688 +98 51 3225 0044 fathi_midwife@yahoo.com Islamic Azad University scientific Leyla Porali
Gham Hospital
Mashhad Iran (Islamic Republic of) 9179734688 +98 51 3859 1511 pouralil@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Having adequate literacy to fill out the forms Lack of menstruation at least in the past 12 months Natural menopause Experiencing at least 4 hot flashes during the day No history of ovarian surgery Confirmation of menopause with the help of hormonal testing and confirmation of E2<18 pg/ml, FSH = 30-110 IU/L Lack of thyroid disorders and TSH = 0.4-4/IU/mL Not using any over-the-counter herbal medicine based on doctor prescription to reduce hot flashes Lack of diabetes, migraine or receiving medication for any internal disorder Lack of chronic infections 45 years 65 years Female N95.1 Menopausal and female climacteric states Treatment - Other Treatment - Drugs Intervention group: Acupuncture performed three times a week, each session took last for 20 minutes. Intervention duration was 4 weeks. Acupuncture points determined based on traditional Korean medicine, including ST36, SP6, L14, PC6, HT7, HT8, and a point at the bottom of the CV4 abdomen. A total of 7 points selected to reduce hot flashes. Metal disposable needles used for the acupuncture in the mentioned points for 20 minutes. The length of the needles were 40 mm. The needles inserted 3-15 mm deep in the mentioned points. Control group: Were received fluoxetine for 4 weeks and subjects were then be followed for 12 weeks Evaluation of the frequency and severity of hot flashes. Timepoint: Before acupuncture, at the end of acupuncture period (4th week) and 12 weeks after acupuncture in the acupuncture group, before fluoxetine treatment, 4 weeks after treatment initiation and 12 weeks after treatment. Method of measurement: Severity of hot flash and Pittsburgh sleep disorder questionnaire. Mashhad University of Medical Sciences Approved 2014-01-29 Ethical Committee of the Mashhad University of Medical Sciences Daneshgah Avenue, Mashhad, Razavi Khorasan Province, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)