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IRCT20220530055026N1 IRCT 2022-11-01 Birjand University of Medical Sciences Comparison of the effect of auriculotherapy and foot reflexology on chemotherapy-induced nausea and vomiting among women with breast cancer Comparison of the effect of auriculotherapy and foot reflexology on chemotherapy-induced nausea and vomiting among women with breast cancer 2022-06-22 anticipated 105 Complete https://irct.ir/trial/63983 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: They are randomly assigned to three groups control, foot reflexology intervention, and auricular therapy intervention by permutation blocking method, Blinding description: Participants will not know which group they are going to be in. Before the intervention, the permutation blocking method determines in which of the three control groups the participant will be placed, foot reflexology intervention or auricular therapy intervention. N/A Chemotherapy-induced nausea and vomiting in women with breast cancer. Intervention 1: First Intervention group: (foot reflexology), the trained person will wash his hands with antibacterial soap after washing the feet and placing the patient in the supine position to support the joint points and then reduce the irritation of the client's skin and the friction of the massage area. It is soaked in baby oil, and foot reflexology is performed continuously for 9 minutes. This massage is performed on one of the client's legs. Massage points include the spleen, stomach, and brain. Massage with a unique foot massage probe by applying moderate pressure on both sides of the upper and middle third of the sole (where the crease of the foot forms when the sole bends) along the second toe and the big toe deeply, causing Do not bother the patient (about 4 kg of alternating pressure for 5 seconds and one second of rest). This way, the spleen point massage will be done for 3 minutes, the stomach area massage will be done for 3 minutes, and the brain area will be massaged for 3 minutes. Then Rhodes nausea and vomiting questionnaire form 2 (INV-2) in patients 6, 12, and 24 hours after the intervention is completed by telephone by the researcher with the client. Intervention 2: Second Intervention group (auriculotherapy): massage points include the spleen, stomach, and subcortex. A trained person first identifies the points to perform the intervention. In the next step, the researcher applies pressure on the selected topics with a unique ear massage probe on the mentioned points (alternating pressure of about one kilogram for 5 seconds with one second of rest). This massage is performed on one of the client's ears. So that the spleen point massage will be done for 3 minutes, 3 minutes massage of the stomach area, 3 minutes massage of the area related to the subcortex in the sole. Auriculotherapy is performed continuously for 9 minutes. In patients 6, 12, and 24 hours after the intervention, the researcher completes a telephone call to the client. Intervention 3: Control group: Routine care will be performed for the control group. In addition, for this group, filling in the Rhodes questionnaire is completed similarly to the last two groups (in terms of completion time and several examinations) by the researcher. 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 Gholam Hossein Mahmoudi Rad
No 30, Ghaffari Ave
Birjand Iran (Islamic Republic of) ۹۷۱۷۸۵۳۵۷۷ +98 56 3238 1400 mahmoudirad@gmail.com Birjand University of Medical Sciences scientific Gholam Hossein Mahmoudi Rad
No. 30, Birjand University of Medical Sciences - School of Nursing and Midwifery, Ghaffari Ave
Birjand Iran (Islamic Republic of) ۹۷۱۷۸۵۳۵۷۷ +98 56 3238 1400 mahmoudirad@gmail.com Birjand University of Medical Sciences Iran (Islamic Republic of) Participants have the consent to participate in the study Have organ health in the legs in the reflexology group Have organ health in the eardrum in the auricular therapy group The patient is fully conscious The patient can understand, read, write and speak Persian. The patient is being treated and has received at least one course of chemotherapy The patient is not undergoing other studies or treatments at the same time The diagnosis of breast cancer is made by an oncologist The results of diagnostic tests have been confirmed by an oncologist 30 years 70 years Female The patient does not have the desire to participate in the study The patient has mental problems, blindness, deafness, or a history of psychological issues The patient does not feel nauseous after chemotherapy The patient is undergoing other studies or treatments at the same time The patient is not fully conscious C50 نئوپلاسم بدخیم پستان Rehabilitation Rehabilitation Rehabilitation First Intervention group: (foot reflexology), the trained person will wash his hands with antibacterial soap after washing the feet and placing the patient in the supine position to support the joint points and then reduce the irritation of the client's skin and the friction of the massage area. It is soaked in baby oil, and foot reflexology is performed continuously for 9 minutes. This massage is performed on one of the client's legs. Massage points include the spleen, stomach, and brain. Massage with a unique foot massage probe by applying moderate pressure on both sides of the upper and middle third of the sole (where the crease of the foot forms when the sole bends) along the second toe and the big toe deeply, causing Do not bother the patient (about 4 kg of alternating pressure for 5 seconds and one second of rest). This way, the spleen point massage will be done for 3 minutes, the stomach area massage will be done for 3 minutes, and the brain area will be massaged for 3 minutes. Then Rhodes nausea and vomiting questionnaire form 2 (INV-2) in patients 6, 12, and 24 hours after the intervention is completed by telephone by the researcher with the client. Second Intervention group (auriculotherapy): massage points include the spleen, stomach, and subcortex. A trained person first identifies the points to perform the intervention. In the next step, the researcher applies pressure on the selected topics with a unique ear massage probe on the mentioned points (alternating pressure of about one kilogram for 5 seconds with one second of rest). This massage is performed on one of the client's ears. So that the spleen point massage will be done for 3 minutes, 3 minutes massage of the stomach area, 3 minutes massage of the area related to the subcortex in the sole. Auriculotherapy is performed continuously for 9 minutes. In patients 6, 12, and 24 hours after the intervention, the researcher completes a telephone call to the client. Control group: Routine care will be performed for the control group. In addition, for this group, filling in the Rhodes questionnaire is completed similarly to the last two groups (in terms of completion time and several examinations) by the researcher. Nausea and vomiting score in Rhodes questionnaire INV 2. Timepoint: Before, 6 hours after, 12 hours after, 24 hours after the intervention. Method of measurement: Rhodes Nausea and Vomiting Questionnaire Form 2 (INV-2). Birjand University of Medical Sciences Approved 2022-02-20 Ethics Committee of Birjand University of Medical Sciences No.30,Central Organization of Birjand University of Medical Sciences, Ghaffari Ave., Birjand South Khorasan Iran (Islamic Republic of)