Determine the effect of solution-Focused counseling on depression and quality of life in women after mastectomy

The effect of solution-oriented counseling on depression and quality of life in women after mastectomy

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3, on 70 patients. For randomization, block randomization method was used in 7 blocks of 10 using online software www.sealedenvelope.com.

This study will be performed in Valiasr Hospital in Arak. So that 70 female patients after mastectomy will be randomly divided into two groups of control and intervention. patients in both groups will be assessed by a pre-test and will be referred to a psychiatrist in case of severe depression and will be excluded from the study. Patients in the control group will receive routine care, and patients in the intervention group will receive solution-oriented counseling in addition to routine care. Patients are not aware of the type of counseling performed and The person who analyzes the information is blinded too, So the study will be double-blind. After the intervention, the severity of depression in patients and their quality of life will be re-evaluated.

Inclusion criteria: age 25 to 55 years, unilateral radical mastectomy during the last 2 to 5 years. exclusion criteria: Chronic physical illness, death of relatives, mental illness, related counseling, chemotherapy and radiotherapy

Control group: 35 patients will receive routine post-mastectomy care after enrollment. Intervention group:35 patients will be treated with solution-oriented psychological counseling In addition to routine care after entering the study. counseling 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 specific and single counselor on a regular and weekly basis.

Depression, quality of life

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.

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.