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IRCT20100211003329N12 IRCT 2025-05-19 Kashan University of Medical Sciences The effect of ear acupressure on sexual function in women with diabetes mellitus The effect of ear acupressure on sexual function in women with diabetes mellitus 2025-06-21 anticipated 60 Complete https://irct.ir/trial/83250 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible samples will be listed in order of screening and then randomly assigned to each of the two intervention and sham groups in blocks of 4 and 6. Using Sealed Envelope Ltd. 2017 software available at www.sealedenvelope.com, 6 blocks of 6 and 6 blocks of 4 were defined, for a total of 12 blocks, and allocation to groups will be done in the order specified by the software, Blinding description: The subject/participant is unaware of the nature of the seeds prescribed to her, and the person collecting the data is also unaware of the subject's group. N/A Diabetes mellitus. Intervention 1: Intervention group: the researcher will attach ZHONG YANG brand Vaccaria seeds made in China to 5 points affecting sexual function, including: internal and external genitalia, shoulder, hip and posterior pituitary points, and the patient will be instructed to press each point using the thumb and index finger for four weeks, five days a week, four times a day, and each time for 20 seconds. It should be noted that during the 4-week intervention, Vaccaria seeds in the intervention group will be attached alternately to both ears every week by the researcher, after cleaning the skin with alcohol cotton. The seeds will be placed on the ear five days a week, and the patient will be asked to remove the adhesives at the end of the fifth day to prevent a possible allergic reaction. The patient will be instructed to contact the researcher if the adhesives come off during the five-day period so that the researcher can reattach the seeds at the agreed-upon location. During the intervention, the individual will also be provided with a weekly diary sheet in which they will record the duration of each pressure point, the occurrence of allergic reactions, and the start of new medication. The contents of the diary sheet are organized using visual symbols in a way that can be understood and completed by all subjects, both literate and illiterate, with simple training. During the intervention, all participants will be visited every week at the agreed-upon location and new seeds will be attached to them, and the diary sheet will be returned to them and another sheet will be given to them for the following week. If the average daily pressure on the testicles in the intervention group is less than 200 seconds during each week of the intervention, that person will be excluded from the study. The testicles will be taped for 4 weeks, and the samples will be followed up 4 weeks after the end of the intervention. The FSFI and SQOL-F questionnaires will be completed at the beginning of the study, after the end of the intervention, and 4 weeks after the end of the intervention for both groups through an interview with the individual by a collaborator who is not aware of the status of the allocation of the samples to the groups. At the time of sampling, the telephone number and home address of the samples will be recorded, and during the intervention period, at the end of each week, and also for the purpose of following up 4 weeks after the end of the intervention, coordination will be made with the patient by telephone regarding the time and place of the visit and, if necessary, transportation. Intervention 2: Control group: The patches will be applied to the internal and external genitalia, shoulder, hip, and posterior pituitary, but without seeds, and no pressure will be applied to them. During the 4-week intervention, the patches without seeds in the sham group will be applied alternately to both ears by the researcher every week, after cleaning the skin with alcohol swabs. The seeds will be on the ears for five days a week, and the patient will be asked to remove the patches at the end of the fifth day to prevent a possible allergic reaction. The patient will be instructed to contact the researcher if the patches are removed during the five-day period so that the patches can be reapplied by the researcher at an agreed location. No - There is not a plan to make this available Justification or reason for not sharing IPD is Not done yet.
public Zahra Tagharrobi
Kashan University of Medical Sciences, Pezeshk Blvd, Qutb Rawandi Blvd, Kashan
Kashan Iran (Islamic Republic of) 8715981151 +98 31 5510 3119 tagharrobi_z@yahoo.com Kashan University of Medical Sciences scientific Zahra Tagharrobi
Kashan University of Medical Sciences, Pezeshk Blvd, Ghotb Ravandi Blvd, Kashan
kashan Iran (Islamic Republic of) 8715981151 +98 31 5510 3119 tagharrobi_z@yahoo.com Kashan University of Medical Sciences Iran (Islamic Republic of) Obtaining a score of 28 or less on the FSFI tool At least one year has passed since the diagnosis of diabetes mellitus Consent to participate in the study living with a spouse, at least one year has passed since permanent marriage wife monogamy At least 6 months have passed since the birth or abortion Muslim couple Iranian citizenship and resident in Kashan Organ health in the earlobe area 18 years no limit Female Pregnancy, breastfeeding and menopause Suffering from serious acute or chronic complications of diabetes (such as eye, kidney, wound, infection) Suffering from physical or mental illnesses or conditions that affect sexual function (such as heart, kidney, malignant diseases, etc.) Simultaneous use of other therapeutic methods Taking medication that affects sexual function Use of acupuncture or acupressure within the past 3 months Being away from spouse for more than two weeks Allergy to glue (sensitivity, redness, etc.) Drug or alcohol abuse in couples Exposure to serious stress during the past 6 months in either partner Drug, alcohol, or cigarette abuse E08 Diabetes mellitus due to underlying condition Treatment - Drugs Placebo Intervention group: the researcher will attach ZHONG YANG brand Vaccaria seeds made in China to 5 points affecting sexual function, including: internal and external genitalia, shoulder, hip and posterior pituitary points, and the patient will be instructed to press each point using the thumb and index finger for four weeks, five days a week, four times a day, and each time for 20 seconds. It should be noted that during the 4-week intervention, Vaccaria seeds in the intervention group will be attached alternately to both ears every week by the researcher, after cleaning the skin with alcohol cotton. The seeds will be placed on the ear five days a week, and the patient will be asked to remove the adhesives at the end of the fifth day to prevent a possible allergic reaction. The patient will be instructed to contact the researcher if the adhesives come off during the five-day period so that the researcher can reattach the seeds at the agreed-upon location. During the intervention, the individual will also be provided with a weekly diary sheet in which they will record the duration of each pressure point, the occurrence of allergic reactions, and the start of new medication. The contents of the diary sheet are organized using visual symbols in a way that can be understood and completed by all subjects, both literate and illiterate, with simple training. During the intervention, all participants will be visited every week at the agreed-upon location and new seeds will be attached to them, and the diary sheet will be returned to them and another sheet will be given to them for the following week. If the average daily pressure on the testicles in the intervention group is less than 200 seconds during each week of the intervention, that person will be excluded from the study. The testicles will be taped for 4 weeks, and the samples will be followed up 4 weeks after the end of the intervention. The FSFI and SQOL-F questionnaires will be completed at the beginning of the study, after the end of the intervention, and 4 weeks after the end of the intervention for both groups through an interview with the individual by a collaborator who is not aware of the status of the allocation of the samples to the groups. At the time of sampling, the telephone number and home address of the samples will be recorded, and during the intervention period, at the end of each week, and also for the purpose of following up 4 weeks after the end of the intervention, coordination will be made with the patient by telephone regarding the time and place of the visit and, if necessary, transportation. Control group: The patches will be applied to the internal and external genitalia, shoulder, hip, and posterior pituitary, but without seeds, and no pressure will be applied to them. During the 4-week intervention, the patches without seeds in the sham group will be applied alternately to both ears by the researcher every week, after cleaning the skin with alcohol swabs. The seeds will be on the ears for five days a week, and the patient will be asked to remove the patches at the end of the fifth day to prevent a possible allergic reaction. The patient will be instructed to contact the researcher if the patches are removed during the five-day period so that the patches can be reapplied by the researcher at an agreed location. Sexual performance score. Timepoint: At the beginning of the study, after the end of the intervention, and 4 weeks after the end of the intervention. Method of measurement: Rosen et al. Female Sexual Function Questionnaire (FSFI). Sextual quality of life. Timepoint: At the beginning of the study, after the end of the intervention, and 4 weeks after the end of the intervention. Method of measurement: Women's Sexual Quality of Life Questionnaire (SQOL-F). Kashan University of Medical Sciences Approved 2025-04-26 Research Ethics Committees of Faculty of Medicine & Faculty of Dentistry- Kashan University of Medic Kashan University of Medical Sciences, Pezeshk Blvd, Qutb Rawandi Blvd, Kashan Kashan Isfehan Iran (Islamic Republic of)