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IRCT20231128060209N1 IRCT 2024-02-05 Ahvaz University of Medical Sciences the effect of mindfulness – based cognitive counseling on women with breast cancer . Investigating the effect of mindfulness – based cognitive counseling on sexual self-esteem of women with breast cancer after mastectomy. 2024-02-14 anticipated 52 Complete https://irct.ir/trial/74072 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, the total sample size is 52 participants (26 participants in each group, considering the potential for drop), selected in the form of 13 blocks of 4. The random allocation of research samples to Group A (control) and Group B (intervention) will be done by generating random sequences, and the formation of blocks will be done using the Random Allocation Software. Each of the generated random sequences is recorded on a registration card, and the cards are placed inside opaque envelopes (13 envelopes). Finally, the sealed envelopes are placed in a box in order. When the study participants who meet the criteria enter, one of the envelopes is randomly opened by a third person, who is a secretary, and the assigned group becomes apparent. Each block consists of 4 patients, and the order of patients being assigned to Group A or B is determined based on the selected block sequence. The fifth patient is again randomly selected from one of the blocks (selected by the secretary), and the type of intervention is assigned to the fifth to eighth patients according to the order of the blocks, Blinding description: Due to the fact that our intervention is a consultation method, it is not possible to blind the researcher, the consultant (specialist related to the treatment) and the participants, so we can only have the blinding of the analyst (statistician). N/A Sexual self-esteem in women with breast cancer after mastectomy. Intervention 1: The intervention will consist of 8 sessions of 90 minutes in one day, but in 2 separate hours and for 2 groups of 12 people. mindfulness based cognitive counseling will be done for the test group. The content of the counseling sessions is according to the protocol of mindfulness treatment and reference books and includes : meditation - breathing exercises - kindness to painful and damaged body parts - cognitive beliefs - home practice, etc. This process will be done in cooperation with Ahvaz University of Medical Sciences and Ahvaz Hospital. Intervention 2: Control group: If the intervention is effective, the control group will also receive the educational package of Mindfulness based cognitive counseling (including video, audio, PowerPoint, etc.) after completing the study in the form of a CD or file. 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 After consulting with the supervisor and obtaining the consent of the people involved in the study and Ahvaz University of Medical Sciences, I will specify the sharing method. ​
public Sareh Khosravikhorram
Floor 1 , Unit 9, Alley 10 , Imam Hasan Avenue, Shahrak Azadi (District 21), Tehran.
Tehran Iran (Islamic Republic of) 1398675561 +98 21 4459 7092 khosravi.s@ajums.ac.ir Ahvaz University of Medical Sciences scientific Parvaneh Mousavi
School of Nursing and Midwifery - Jundishapur University of Medical Sciences Ahvaz – - Esfand Street – Golestan - Ahvaz – Iran
Ahvaz Iran (Islamic Republic of) 33337- 61357 +98 61 3373 8331 mousavi-p@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) being married Having sex with her husband Having at least one child Women of reproductive age with breast cancer who have undergone total mastectomy surgery After completing chemotherapy Ability to participate in group therapy sessions possessing at least a middle school education Breast cancer diagnosis 6 months to 5 years before participating in the research Obtaining a score lower than 87 from the sexual self-esteem questionnaire Women aged 30 to 49 30 years 49 years Female Suffering from chronic diseases such as blood pressure, diabetes and thyroid and autoimmune diseases Taking Antipsychotic drugs in the last 6 months Active psychotic disorders Use of hormone replacement drugs Drug addiction or dependence on alcohol or psychoactive substances based on the individual's own opinion Treatment of another type of cancer or malignancy The occurrence of an unfortunate event during the last 6 months Participation in concurrent treatment programs to reduce sexual problems and reduce other psychological problems hysterectomy metastasis C50 Malignant neoplasm of breast Rehabilitation Rehabilitation The intervention will consist of 8 sessions of 90 minutes in one day, but in 2 separate hours and for 2 groups of 12 people. mindfulness based cognitive counseling will be done for the test group. The content of the counseling sessions is according to the protocol of mindfulness treatment and reference books and includes : meditation - breathing exercises - kindness to painful and damaged body parts - cognitive beliefs - home practice, etc. This process will be done in cooperation with Ahvaz University of Medical Sciences and Ahvaz Hospital. Control group: If the intervention is effective, the control group will also receive the educational package of Mindfulness based cognitive counseling (including video, audio, PowerPoint, etc.) after completing the study in the form of a CD or file. Sexual self-esteem of breast cancer patients after mastectomy. Timepoint: Comparison of the scores obtained from the short-form female sexual self-esteem questionnaire (SSEI-W-SF ) before and after the intervention in both intervention and control groups. Method of measurement: Women's Sexual Self-Esteem Questionnaire of Zeanah and Schwarz Short Form Persian Version . Ahvaz University of Medical Sciences Approved 2023-11-26 Ethics committee of Ahvaz Jundishapur University of Medical Sciences School of Nursing and Midwifery - Jundishapur University of Medical Sciences Ahvaz – - Esfand Street – Golestan - Ahvaz - Iran Ahvaz Khouzestan Iran (Islamic Republic of)