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IRCT20180218038789N7 IRCT 2023-07-28 Qazvin University of Medical Sciences The effect of ear acupressure on Quality of Life among menopausal women Investigating the effect of ear acupressure on Quality of Life among menopausal women : A randomized sham controlled trial 2023-09-06 anticipated 120 Complete https://irct.ir/trial/71613 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random allocation will be done by balanced blocks randomization method with blocks size of 4. The randomization unit will be the participants. Each letter is assigned to each group to construct the allocation sequence (A: Ear Acupressure Intervention Group, B: Sham control Group). The allocation sequence will then be generated using online methods without individual intervention. Then, to conceal the allocation sequence, the sequence is written on the sheets and placed in sealed envelopes, respectively, Blinding description: For blinding, the placebo group will be used as a sham. The sham group is used in such a way that special labels for auriculotherapy, which contain SID to create pressure in the position, will be used in the auriculotherapy group. In the sham group, the same labels but without seeds will be used to remove the pressure effect at the same points. In this way, none of the eligible people know which group they are in. The outcome assessment will be done by a trained person outside the research team without knowing the assigned group of people and using a telephone interview. The person who will do the analysis will also do the analysis only based on the codes and will not know about the intervention and control groups. 3 Quality of life. Intervention 1: Intervention group with ear acupressure: acupressure intervention will be done by placing special adhesives containing Vacaria seeds on points of the ear including Chinese and European uterine points, ovary point, zero point, Shan Man point and brain point, gonadotrophin point and sympathetic point. A number of 10 sessions will be held at intervals of four days for each person, and during this period, each point should press selected ear acupoints three times a day for twenty seconds. The material used in this study is special auriculotherapy adhesives containing vacaria seeds, which is a product of China. This product will be available from medical equipment stores. Intervention 2: Control group (sham): will receive the same visits as the intervention group. In this group, special adhesives without Vacaria seeds will be placed on the same points of the ear as the intervention group. A number of 10 sessions will be held at four-day intervals for each person, and they are also asked to press the identified ear acupoints three times a day for twenty seconds. Yes - There is a plan to make this available What will be shared: Data can be shared after de-identifying individuals in correspondence with the responsible researcher. When: As soon as the findings are published as articles in scientific journals To whom: For academic researchers and after submitting a formal request and explaining the reasons for needing access to the data Conditions: For use in secondary analysis and meta-analysis Where to obtain: Send the request to the responsible researcher's email (Zainab Alimoradi) How to obtain: The data will be sent to the requester within one month after sending the request with sufficient explanation Comments:
public Zainab Alimoradi
Qazvinو Bahonar blevard
Qazvin Iran (Islamic Republic of) 3419759811 +98 28 3333 6003 zainabalimoradi@yahoo.com Qazvin University of Medical Sciences scientific Zainab Alimoradi
Bahonar blevard, Qazvin university of Medical Science, School of Nursing & Midwifery
Qazvin Iran (Islamic Republic of) 3419759811 +98 28 3333 6003 zainabalimoradi@yahoo.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Being married Being menopause Has a natural earlobe without lesions, sores and pain in the earlobe Having a literacy education Availability during the study period 45 years no limit Female History of chronic mental and physical illness (self-report and review of the individual's file) Substance abuse in the person or his spouse History of using acupressure in the last three months History of stressful events in the last three months (such as the loss of a loved one) Treatment - Other Placebo Intervention group with ear acupressure: acupressure intervention will be done by placing special adhesives containing Vacaria seeds on points of the ear including Chinese and European uterine points, ovary point, zero point, Shan Man point and brain point, gonadotrophin point and sympathetic point. A number of 10 sessions will be held at intervals of four days for each person, and during this period, each point should press selected ear acupoints three times a day for twenty seconds. The material used in this study is special auriculotherapy adhesives containing vacaria seeds, which is a product of China. This product will be available from medical equipment stores. Control group (sham): will receive the same visits as the intervention group. In this group, special adhesives without Vacaria seeds will be placed on the same points of the ear as the intervention group. A number of 10 sessions will be held at four-day intervals for each person, and they are also asked to press the identified ear acupoints three times a day for twenty seconds. Quality of life of postmenopausal women. Timepoint: Before the intervention, one and two months after the end of the intervention. Method of measurement: Quality of life questionnaire for postmenopausal women. Qazvin University of Medical Sciences Approved 2023-07-12 Ethics committee of Qazvin University of Medical Sciences Qazvin, Bahonar blevard Qazvin Qazvin Iran (Islamic Republic of)