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IRCT20181130041803N1 IRCT 2018-12-03 Tehran University of Medical Sciences The effect of provision of information on anxiety before surgery in patients with breast cancer The effect of provision of information on anxiety before surgery in patients with breast cancer 2019-01-05 anticipated 80 Complete https://irct.ir/trial/35587 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random Rearranged Block Designs Two Blind Quadruple Treatments: Thus, the letter A for the intervention group and the letter B for the control group are considered. Then we write all the reciprocal combinations of the letters A, A, B and B, which are 6 different combinations, on the 6 cards, thus: 1. AABB 2. ABBA 3. ABAB 4. BAAB 5. BABA 6. BBAA Then we select random numbers from digits 1 through 6 (by random number table or patient number one we want to randomly select a card). For example, if the number 2 is selected, the concept is that the first person in the intervention group was the next two in the control group and the fourth in the intervention group, and we continue to do this until the sample size reaches the quotient. N/A Condition 1: Breast Cancer. Condition 2: Salivary cortisol. Condition 3: Anxiety before surgery. Intervention 1: Intervention group: Patients in the intervention group included all patients aged 18 years before menopause with definite diagnosis of breast cancer who were admitted for unilateral mastectomy for at least 24 hours in the Department of Women's Surgery or Immunomotor Cancer Institute who were randomly assigned to blocks Four have been selected in this group after collecting information about demographic and salivary samples from 3 to 5 cc before being informed. Saliva samples are taken to measure cortisol concentrations between 8:30 and 7:30 in the morning. Brushing and eating and drinking is not allowed for the client for half an hour before taking saliva. Samples are immediately sent to the laboratory and freeze at -20 ° F. Then it is centrifuged at 2500 rpm and ultimately measured by ELISA and using the kit of salivary cortisol. Then, the DASS-21 anxiety inventory questionnaire will be completed by patients with the presence of the researcher. To the intervention group, in order to inform and inform before surgery, the written information includes information on patient health and surgical care and post-operative care, and oral explanations and responses to the questions of the patients are also done by the researcher. The saliva sample is collected again and the DASS-21 questionnaire is completed. Intervention 2: Control group: Patients in the control group included all patients aged 18 before menopause with a diagnosis of breast cancer who were admitted for unilateral mastectomy for at least 24 hours in the gynecologic department of Imam Khomeini Cancer Institute who were randomly assigned to blocks Four have been selected in this group after collecting information about demographic and salivary samples from 3 to 5 cc before being informed. Saliva samples are taken to measure cortisol concentrations between 8:30 and 7:30 in the morning. Brushing and eating and drinking is not allowed for the client for half an hour before taking saliva. Samples are immediately sent to the laboratory and freeze at -20 ° F. Then it is centrifuged at 2500 rpm and ultimately measured by ELISA and using the kit of salivary cortisol. Then, the DASS-21 anxiety inventory questionnaire will be completed by patients with the presence of the researcher. The control group only receives routine pre-surgical training information. Then again, collect the saliva and complete the DASS-21 questionnaire. Yes - There is a plan to make this available What will be shared: The total potential data can be shared after unidentifiable individuals When: Get started 6 months after printing results To whom: Researchers in academic and scientific institutions Conditions: Post-print results will be announced Where to obtain: Library of the Faculty of Nursing and Midwifery, Tehran University of Medical Sciences How to obtain: Post-print results will be announced Comments:
public sara pakzad karamad
School of Nursing Midwifery ,Tehran University of Medical Sciences Nosrat st. Tohid sq
tehran Iran (Islamic Republic of) 1419733171 +98 21 7751 4933 sarah.pakzad.karamad.1991@gmail.com Tehran University of Medical Sciences scientific sara pakzad karamad
School of Nursing Midwifery ,Tehran University of Medical Sciences Nosrat st. Tohid sq
tehran Iran (Islamic Republic of) 141973317 +98 21 6691 4368 sarah.pakzad.karamad.1991@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) The first surgical experience Ability to read and write Mastering in Persian language There is no familial relationship with other participants in the research There is no cancer in the family Not to be a medical staff Do not have a speech and hearing problem Dementia and cognitive impairment At least 24 hours in hospital No medications that reduce or increase cortisol (such as corticosteroids, anticonvulsants, insulin) One-way mastectomy candidate is a one-way mastectomy candidate Definitive diagnosis of breast cancer 18 years 60 years Female Any severe changes and deterioration in the condition during the study Any type of offensive treatment during the study Any patient dissatisfaction during the implementation of the project N/A N/A Intervention group: Patients in the intervention group included all patients aged 18 years before menopause with definite diagnosis of breast cancer who were admitted for unilateral mastectomy for at least 24 hours in the Department of Women's Surgery or Immunomotor Cancer Institute who were randomly assigned to blocks Four have been selected in this group after collecting information about demographic and salivary samples from 3 to 5 cc before being informed. Saliva samples are taken to measure cortisol concentrations between 8:30 and 7:30 in the morning. Brushing and eating and drinking is not allowed for the client for half an hour before taking saliva. Samples are immediately sent to the laboratory and freeze at -20 ° F. Then it is centrifuged at 2500 rpm and ultimately measured by ELISA and using the kit of salivary cortisol. Then, the DASS-21 anxiety inventory questionnaire will be completed by patients with the presence of the researcher. To the intervention group, in order to inform and inform before surgery, the written information includes information on patient health and surgical care and post-operative care, and oral explanations and responses to the questions of the patients are also done by the researcher. The saliva sample is collected again and the DASS-21 questionnaire is completed Control group: Patients in the control group included all patients aged 18 before menopause with a diagnosis of breast cancer who were admitted for unilateral mastectomy for at least 24 hours in the gynecologic department of Imam Khomeini Cancer Institute who were randomly assigned to blocks Four have been selected in this group after collecting information about demographic and salivary samples from 3 to 5 cc before being informed. Saliva samples are taken to measure cortisol concentrations between 8:30 and 7:30 in the morning. Brushing and eating and drinking is not allowed for the client for half an hour before taking saliva. Samples are immediately sent to the laboratory and freeze at -20 ° F. Then it is centrifuged at 2500 rpm and ultimately measured by ELISA and using the kit of salivary cortisol. Then, the DASS-21 anxiety inventory questionnaire will be completed by patients with the presence of the researcher. The control group only receives routine pre-surgical training information. Then again, collect the saliva and complete the DASS-21 questionnaire. Measuring the salivary cortisol. Timepoint: ۶۷/۵۰۰۰Measure salivary cortisol before the intervention and the morning after the intervention. Method of measurement: Salivary Cortisol Measurement by ELISA Method by Measuring Saline Cortisol Kit. Psychological anxiety score of patients with mastectomy candidates in DASS-21 questionnaire. Timepoint: Measurement of anxiety at the beginning of the study and the day after the interventionپرسشنامه. Method of measurement: Anxiety and Stress Questionnaire DASS-21. Tehran University of Medical Sciences Approved 2018-11-06 کمیته اخلاق در پژوهش های زیست پزشکی Tehran University of Medical Sciences.,Dr Mirkhani St. (Eastern Nusrat).,Tohid Square تهران Tehran Iran (Islamic Republic of)