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IRCT20201021049103N1 IRCT 2020-12-01 Arak University of Medical Sciences Effect of solution-Focused counseling on depression after mastectomy Determine the effect of solution-Focused counseling on depression and quality of life in women after mastectomy 2020-07-22 anticipated 70 Complete https://irct.ir/trial/51822 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After admission to the study, 70 patients will be divided into control and intervention groups in 7 blocks of 10 using block randomization method with online statistical software (www.sealedenvelope.com). Then the method of sealed opaque envelopes was used to hide the sequences. In this way, a number of envelopes with aluminum wrappers (in order to obscure the contents of the envelopes) are prepared and each of the random sequences created is recorded on a card and the cards are placed inside the envelopes in order. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed, Blinding description: In this study, patients are not aware of the type of counseling that is done for them and the number and time of sessions and the counselor is the same for all patients in both groups and the analyzer of the obtained data is not aware of the type of groups and recognizes the groups based on the letters A and B. Therefore, this study is a double-blind study. In this study, the counselor and the main executor of the study are aware of the study groups and the type of intervention. 3 Depression. Intervention 1: Intervention group: In this group, 35 patients will be treated with solution-oriented psychological counseling In addition to routine care after entering the study. Solution-oriented counseling is a counseling approach based on the De Shazer solution-oriented counseling protocol, which in this study is performed in the form of 6 sessions of 1.5 hours on women after mastectomy. Counseling in all patients will be done by a single specific counselor on a regular and weekly basis. Intervention 2: Control group: In this group, 35 patients will undergo routine care after mastectomy after entering the study, Which includes medical care and In addition, patients will receive regular (non-solution-oriented) psychological counseling, which is performed in the form of 6 1.5-hour counseling sessions for women after mastectomy. Counseling in all patients will be done by a specific and single counselor on a regular and weekly basis. 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 No more information
public Leila Pirzadi
Payambar-e-azam Complex, Basij Sq., Sardasht
Arak Iran (Islamic Republic of) 3819693145 0098864173152 pirzadil1378@gmail.com Arak University of Medical Sciences scientific Leila Pirzadi
Payambar-e-azam Complex, Basij Sq., Sardasht
Arak Iran (Islamic Republic of) 3814957558 +98 86 3223 1283 pr_valieasr@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) Age 25 to 55 years Unilateral radical mastectomy over the last 2 to 5 years 25 years 55 years Female Chronic physical illness Death of relatives Having mental diseases Get related Consulting Radiotherapy and chemotherapy F32 Major depressive disorder, single episode Rehabilitation N/A Intervention group: In this group, 35 patients will be treated with solution-oriented psychological counseling In addition to routine care after entering the study. Solution-oriented counseling is a counseling approach based on the De Shazer solution-oriented counseling protocol, which in this study is performed in the form of 6 sessions of 1.5 hours on women after mastectomy. Counseling in all patients will be done by a single specific counselor on a regular and weekly basis. Control group: In this group, 35 patients will undergo routine care after mastectomy after entering the study, Which includes medical care and In addition, patients will receive regular (non-solution-oriented) psychological counseling, which is performed in the form of 6 1.5-hour counseling sessions for women after mastectomy. Counseling in all patients will be done by a specific and single counselor on a regular and weekly basis. Depression. Timepoint: Pre-intervention evaluation using pre-test, post-intervention evaluation using post-test. Method of measurement: Beck Depression Inventory. Quality of life. Timepoint: Before the intervention and after the intervention. Method of measurement: WHOQOL-BREF questionnaire. Arak University of Medical Sciences Approved 2020-02-02 Ethics committee of Arak University of Medical Sciences Payambar-e-azam Complex, Basij Sq., Sardasht Arak Markazi Iran (Islamic Republic of)