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IRCT20230124057208N1 IRCT 2023-01-30 Bagheiat-allah University of Medical Sciences Comparison of the effect of aromatherapy and acupressure on depression and quality of life in women with breast cancer Comparison of the effect of aromatherapy and acupressure on depression and quality of life in women with breast cancer 2023-02-28 anticipated 96 Complete https://irct.ir/trial/68240 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: Dividing people by random allocation method into three aromatherapy groups, acupressure and control group In order to random allocation, block random allocation method with six blocks was used. In this way, the aromatherapy test group was assigned the letter A and acupressure the letter B, and the control group was assigned the letter C, and it was written in blocks of six with the letters A, B, and C, on separate sheets, and inside A container was thrown and randomly one of these sheets was taken out of the container and the composition written on it was noted and that sheet was again thrown into the container. Because the sample size in this study was 96 patients, this procedure was repeated 16 times and each time the composition written on each sheet was noted in the sequence of the composition written on the previous sheet. Then, each letter was assigned a number from one to eighty in the order of the letters memorized one after the other, and each letter was placed in an envelope and the number of that letter was written on the envelope. Each time a patient was selected, one of these envelopes was opened in the order of the number written on the envelope and it was determined that the patient should be placed in the test or control group. N/A Condition 1: Depression in women with breast cancer. Condition 2: Quality of life in women with breast cancer. Intervention 1: Intervention group: In the case of the aromatherapy group, 7 drops of lavender essential oil are dripped with a dropper on a 20x20 non-absorbable polyethylene napkin and attached to the patient's collar with a pin, and they are asked to wear it for 30 Breathe normally for a minute. This intervention will be carried out for 3 days a week for four weeks. Intervention 2: The second intervention group: In the acupressure group, pressure will be used in the P6 area. This point is located three fingers above the crease line of the wrist, on the inner surface of the forearm, on the midline (in the cavity between the last bones of the forearm). In this method, pressure of 3 to 4 kg will be done for 8 minutes with the thumb (three minutes at each point and two minutes of rest) in a circular manner and two rounds per second in both hands and three days a week for 4 weeks. . In order to check the reliability and validity of acupressure, choosing the right points to apply pressure and the amount of pressure force, the researcher will be trained and evaluated by a traditional medicine specialist of the University of Medical Sciences, and the correctness of performing acupressure at the designated point will be confirmed. It is fully presented so that they can continue the intervention at home and the patients will also be evaluated by the researcher so that the accuracy of their work is confirmed by the researcher. Patients will also be taught that the positive effect of massage is confirmed if the client feels warmth, heaviness, swelling or numbness at that point. Intervention 3: Control group: For patients in the control group, no intervention is 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 Still undecided - no release schedule yet. There is no further information
public Leila Karimi
Vanak, Mulla Sadra St., Sheikh Bahai St
Tehran Iran (Islamic Republic of) 1435915371 +98 21 8755 5485 leilakarimi@bmsu.ac.ir Bagheiat-allah University of Medical Sciences scientific Leila Karimi
Vanak, Mulla Sadra St., Sheikh Bahai St
Tehran Iran (Islamic Republic of) 1435915371 +98 21 8755 5485 leilakarimi@bmsu.ac.ir Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Breast cancer for 1-3 years Suffering from mild and moderate depression according to the Beck depression questionnaire Not taking antidepressants and anti-anxiety drugs No consumption of psychoactive substances, alcohol and tobacco Reading and writing literacy to complete the questionnaire Married Absence of suffering from other mental problems according to the statement of the person or family member Absence of olfactory disorder according to the statement of the patient or a family member Not suffering from eczema and hives or allergies to flowers, plants and respiratory problems such as asthma 18-60 years old 18 years 60 years Female Avoiding continuing to participate in the study at any stage Any reaction to aromatherapy or acupressure Aggravation of the disease during the study in such a way that prevents the continuation of the study. C00-D49 C00-D49 Neoplasms of unspecified behavior Neoplasms of unspecified behavior Rehabilitation Rehabilitation Other Intervention group: In the case of the aromatherapy group, 7 drops of lavender essential oil are dripped with a dropper on a 20x20 non-absorbable polyethylene napkin and attached to the patient's collar with a pin, and they are asked to wear it for 30 Breathe normally for a minute. This intervention will be carried out for 3 days a week for four weeks. The second intervention group: In the acupressure group, pressure will be used in the P6 area. This point is located three fingers above the crease line of the wrist, on the inner surface of the forearm, on the midline (in the cavity between the last bones of the forearm). In this method, pressure of 3 to 4 kg will be done for 8 minutes with the thumb (three minutes at each point and two minutes of rest) in a circular manner and two rounds per second in both hands and three days a week for 4 weeks. . In order to check the reliability and validity of acupressure, choosing the right points to apply pressure and the amount of pressure force, the researcher will be trained and evaluated by a traditional medicine specialist of the University of Medical Sciences, and the correctness of performing acupressure at the designated point will be confirmed. It is fully presented so that they can continue the intervention at home and the patients will also be evaluated by the researcher so that the accuracy of their work is confirmed by the researcher. Patients will also be taught that the positive effect of massage is confirmed if the client feels warmth, heaviness, swelling or numbness at that point. Control group: For patients in the control group, no intervention is performed. Depression score in Beck Depression questionnaire. Timepoint: before intervention and four weeks after intervention. Method of measurement: Beck's Depression Questionnaire II. Quality of life. Timepoint: before intervention and four weeks after intervention. Method of measurement: Two questionnaires will be used:Quality of life questionnaire for Cancer patients Belongs to the European Organization for Research and Treatment of Cancer AND Quality of life questionnaire for Brest Cancer patients Belongs to the European Organization for Research and Treatment of Cancer. Depression score in Beck Depression questionnaire. Timepoint: before intervention and four weeks after intervention. Method of measurement: Beck's Depression Questionnaire II. Quality of life. Timepoint: before intervention and four weeks after intervention. Method of measurement: Two questionnaires will be used:Quality of life questionnaire for Cancer patients Belongs to the European Organization for Research and Treatment of Cancer AND Quality of life questionnaire for Brest Cancer patients Belongs to the European Organization for Research and Treatment of Cancer. Bagheiat-allah University of Medical Sciences Approved 2021-12-21 Ethics Committee of Baqiyatullah University Vank, Mulla Sadra St., Sheikh Bahai St., Baqiyatullah University Tehran Tehran Iran (Islamic Republic of)