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IRCT20190728044351N1 IRCT 2019-08-27 Kerman University of Medical Sciences Investigating the comparative effectiveness of biofeedback and auriculotherapy on menopoused women’s hot flashes referred to private clinics of gynecologists - Investigating the comparative effectiveness of biofeedback and auriculotherapy on menopoused women’s hot flashes referred to private clinics of gynecologists in Kerman city, 2019 2019-08-23 anticipated 39 Complete https://irct.ir/trial/41161 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Simple random and accessible All postmenopausal women referred to the gynecologist's office within the first 4 days of the week Which are divided into throwing coins into specified groups. N/A Hot flashes. Intervention 1: Intervention group: Biofeedback Group:In this group of Canadian biofeedback device BioGraph Infiniti V4 Plus (Infiniti SN: CB1726 \ Enc Key Cod:(848981408 \ App Key Code: 1589114055 is used by the researcher to perform biofeedback. Each subject in the office and under controlled conditions, the relevant biofeedback is recorded and recorded as a baseline.Respiratory Biofeedback: In a respiratory biofeedback, the relevant sensors are installed around the person's chest and the person is instructed to look at the training monitor to change their breathing pattern.Biofeedback for heart rate: This type of biofeedback is known as a method for heart rate variability. As the name implies, it helps the person control their heart rate.Skin response: In skin response method, the sweat of the skin surface is measured. The level of sweating on the skin, called the skin's electrical response, is a good criterion for examining emotions in a person. That is, the emotional state of the skin's electrical response changes.Skin temperature: People experience a decrease in skin temperature during stress. By monitoring skin temperature, people learn when to enter the stress and anxiety phase and how they can control it. Intervention 2: Intervention group: Biofeedback Group:Uriculotherapy Group:Researcher after disinfecting the ear with 70% alcohol in endocrine, ovarian, Shen Man, Long I in the left ear and Master Scholler points in anxiety, thalamic in the right ear by Excel 2 device, stimulated each point for 5 seconds and then Put labels containing the plant Vakaria (Say) that can remain in spots for three days at the specified points in the ears and teach the study subjects to sit on the spot every two hours for one minute with Press the finger (emphasis added to the extent that it causes pain and burning in the outer ear). Intervention 3: Control group: Control group receiving routine care. Yes - There is a plan to make this available What will be shared: All individual data of study participants are shared after unidentifiable individuals When: The access period begins 6 months after the results are published To whom: The data will be available to researchers working in academic and scientific institutions Conditions: Applicable to complementary medicine groups Where to obtain: Email address, or website, and phone and fax numbers, along with the names and addresses of the respondent How to obtain: Minimum time needed to get one week of documentation Comments:
public Somayeh Sadat Eslami
Seven Garden Alavi Highway
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3340 1256 sos.eslami@gmail.com Kerman University of Medical Sciences scientific Somayeh Sadat Eslami
Seven Garden Alavi Highway
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3340 1256 sos.eslami@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) At least one year after menstruation Hot flashes at least twice a day Age 60-45 years old Willingness to participate in the research project and to complete the written consent form Being Iranian 45 years 60 years Female History of hysterectomy and ophorectomy Hypertension and Cardiovascular Diseases, Thromboembolic, Thyroid Endocrine Use of tobacco or alcohol Malignancy Abnormal vaginal bleeding taking hormones and taking drugs that affect vasomotor symptoms Z76.89 Chapter XXIFactors influencing health status and contact with health services(Z00-Z99) Behavior Treatment - Devices Other Intervention group: Biofeedback Group:In this group of Canadian biofeedback device BioGraph Infiniti V4 Plus (Infiniti SN: CB1726 \ Enc Key Cod:(848981408 \ App Key Code: 1589114055 is used by the researcher to perform biofeedback. Each subject in the office and under controlled conditions, the relevant biofeedback is recorded and recorded as a baseline.Respiratory Biofeedback: In a respiratory biofeedback, the relevant sensors are installed around the person's chest and the person is instructed to look at the training monitor to change their breathing pattern.Biofeedback for heart rate: This type of biofeedback is known as a method for heart rate variability. As the name implies, it helps the person control their heart rate.Skin response: In skin response method, the sweat of the skin surface is measured. The level of sweating on the skin, called the skin's electrical response, is a good criterion for examining emotions in a person. That is, the emotional state of the skin's electrical response changes.Skin temperature: People experience a decrease in skin temperature during stress. By monitoring skin temperature, people learn when to enter the stress and anxiety phase and how they can control it. Intervention group: Biofeedback Group:Uriculotherapy Group:Researcher after disinfecting the ear with 70% alcohol in endocrine, ovarian, Shen Man, Long I in the left ear and Master Scholler points in anxiety, thalamic in the right ear by Excel 2 device, stimulated each point for 5 seconds and then Put labels containing the plant Vakaria (Say) that can remain in spots for three days at the specified points in the ears and teach the study subjects to sit on the spot every two hours for one minute with Press the finger (emphasis added to the extent that it causes pain and burning in the outer ear). Control group: Control group receiving routine care Hot flashes. Timepoint: Before intervention, demographic questionnaire and hot flash questionnaire were completed by all three groups and completed 4 weeks and 8 weeks after the intervention. Method of measurement: Questionnaire. Neuroscience Research Center Approved 2019-07-24 Ethics committee of Kerman University of Medical Sciences Seven Garden Alavi Highway Kerman Kerman Iran (Islamic Republic of)