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IRCT20130812014333N167 IRCT 2021-04-18 Kermanshah University of Medical Sciences The effect of acupuncture points stimulation on sleep quality and menopausal symptoms in postmenopausal women The effect of acupuncture points stimulation with transcutaneous electrical acupoint stimulation device on sleep quality and menopausal symptoms in postmenopausal women 2021-05-20 anticipated 39 Complete https://irct.ir/trial/55425 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The permutation random block is used for randomization. In this way, first, the total sample size and the ratio of sample size in groups are determined. Then, the number of samples will be selected from the table of random numbers of single-digit numbers between 0 and 9. For studies with two groups, the numbers 0-9 are divided into two equal blocks with a probability of assigning an individual to each block is 0.5. Block 4-0 for the first group and block 5-9 for the second treatment can be used. Based on the selected numbers from the table of random numbers and the determination of blocks, it is clear in which group each person who enters the study will be placed. 2-3 Condition 1: Quality of Sleep. Condition 2: Menopausal symptoms. Intervention 1: In the intervention group, six bilateral HT7, P6 and LI4 acupuncture points will be performed for four weeks twice a week (eight sessions) for five minutes each time for fifty seconds for each point. Intervention 2: In the first control group, six bilateral HT7, P6 and LI4 acupuncture points will be performed for four weeks twice a week (eight sessions) for five minutes each time for fifty seconds for each point, but the device is off. Intervention 3: In the second control group, no intervention will be performed. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Somayeh Parvandi
Isar Square, Dolatabad Blvd, Faculty of Nursing and Midwifery
Kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3826 6429 sheydarpour@kums.ac.ir Kermanshah University of Medical Sciences scientific Dr. Sosan Heydarpour
Isar Square, Dolatabad Blvd, Faculty of Nursing and Midwifery
Kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3826 6429 sheydarpour@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) No history of acupuncture; A minimum of one year and a maximum of 4 years have elapsed since the last menstrual period No use of hormone therapy for the past 6 months A normal menopause 47 years 57 years Female Very severe menopausal symptoms that affect sleep quality Severe depressive disorder and anxiety Drug addiction G47.9 N95.1 Sleep Disorder, Unspecified Menopausal and female climacteric states Treatment - Other Other N/A In the intervention group, six bilateral HT7, P6 and LI4 acupuncture points will be performed for four weeks twice a week (eight sessions) for five minutes each time for fifty seconds for each point. In the first control group, six bilateral HT7, P6 and LI4 acupuncture points will be performed for four weeks twice a week (eight sessions) for five minutes each time for fifty seconds for each point, but the device is off. In the second control group, no intervention will be performed Sleep quality. Timepoint: End of the intervention and one month after the end of the intervention. Method of measurement: Based on the Pittsburgh Sleep Quality Questionnaire. Flushing. Timepoint: Before and after the intervention (one month later). Method of measurement: Using the Visual Scale (VAS). Kermanshah University of Medical Sciences Approved 2021-03-09 Ethics committee of Kermanshah University of Medical Sciences Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard Kermanshah Kermanshah Iran (Islamic Republic of)