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IRCT20180616040113N1 IRCT 2019-02-15 Ahvaz University of Medical Sciences The effect of Cognitive Behavioral Therapy (CBT) on sexual function and satisfaction of women with breast cancer The effectiveness of Cognitive Behavioral Therapy (CBT) on sexual function and satisfaction of women with breast cancer after mastectomy 2018-07-06 anticipated 42 Complete https://irct.ir/trial/31995 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In order to intervention, the women will be divided into two groups of 21 participants as control and intervention groups in randomized blocking , using four blocks and a one to one allocation ratio by use RAS software. Then,the intervention and control group's numbers will be held in envelops by block rows. The envelops will be closed and by Golestan Hospital's oncology secretary, they will be randomly assigned to eligible individuals in the study. N/A Sexual function of women with breast cancer. Intervention 1: Intervention group: Cognitive behavioral therapy result in more positive attitude toward sexual relation and improved sexual function disorder of couples. Cognitive-behavioral therapy is organized in 8 group sessions.The research samples are divided into 3 groups of 7 people. The sessions are organized by a researcher once a week for 90 minutes. Educational content includes: Familiarity of members with each other and explaining the model of cognitive-behavioral therapy, Identifying their own thoughts and finding negative thoughts on sexual issues, types of beliefs and changing wrong beliefs, analysis of beneficial, body image and its changes during chemotherapy and mastectomy, relaxation training and imagination and confront negative excitements.Homework is given to the participants. After the end of eight sessions, the sexual function and sexual satisfaction questionnaires are completed by the intervention group. Intervention 2: Control group: Before starting treatment, sexual function Index and sexual satisfaction questionnaires are completed by the control group. Two months after starting treatment, the control group is contacted and sexual function Index and sexual satisfaction questionnaires are again completed, A training session is given to them.Educational content includes body image and its changes during chemotherapy and mastectomy, relaxation training and imagination and confront negative excitements.They are referred to consultant if they wish. No - There is not a plan to make this available Justification or reason for not sharing IPD is there is no more information
public Parvaneh Mousavi
Nursing and Midwifery faculty, Ahvaz Jundishapur University of medical sciences, Golestan Ave, Ahvaz, Iran
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3336 7543 Mousavi-p@ajums.ac.ir Ahvaz University of Medical Sciences scientific Parvaneh Mousavi
Nursing and Midwifery faculty, Ahvaz Jundishapur University of medical sciences, Golestan Ave, Ahvaz, Iran
Ahvaz Iran (Islamic Republic of) 6135715794 +98 613450547 Mousavi-p@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Women with breast cancer after mastectomy Score less than 26.5 of female sexual function index questionnaire Married To have sexual relation with husband To have minimum one child After complete of chemotherapy course Diagnosis of breast cancer 6 month till 5 years before present in research Ability to attend in group therapy session Having at least elementary education Score less than 75 of Larson sexual satisfaction questionnaire Reproductive ages 18-49 years 18 years 49 years Female Pregnancy and lactation Chronic diseases such as hypertension, diabetes and thyroid disease, and autoimmune diseases Menopause Taking antipsychotic drugs during the past 6 months Psychiatric disorders Use of Hormone Replacement Therapy (HRT) Drug addiction or alcohol dependence or psychoactive materials based on personal comments Treatment another type of cancer or malignancy Participate in concurrent therapy programs to reduce sexual problems and reduce other psychological problems The occurrence of a unpleasant event during the last 6 months Hysterectomy C50 Malignant neoplasm of breast Treatment - Other Treatment - Other Intervention group: Cognitive behavioral therapy result in more positive attitude toward sexual relation and improved sexual function disorder of couples. Cognitive-behavioral therapy is organized in 8 group sessions.The research samples are divided into 3 groups of 7 people. The sessions are organized by a researcher once a week for 90 minutes. Educational content includes: Familiarity of members with each other and explaining the model of cognitive-behavioral therapy, Identifying their own thoughts and finding negative thoughts on sexual issues, types of beliefs and changing wrong beliefs, analysis of beneficial, body image and its changes during chemotherapy and mastectomy, relaxation training and imagination and confront negative excitements.Homework is given to the participants. After the end of eight sessions, the sexual function and sexual satisfaction questionnaires are completed by the intervention group. Control group: Before starting treatment, sexual function Index and sexual satisfaction questionnaires are completed by the control group. Two months after starting treatment, the control group is contacted and sexual function Index and sexual satisfaction questionnaires are again completed, A training session is given to them.Educational content includes body image and its changes during chemotherapy and mastectomy, relaxation training and imagination and confront negative excitements.They are referred to consultant if they wish. Sexual function of women with breast cancer. Timepoint: Before the intervention- 8 weeks after intervention. Method of measurement: Female sexual function index questionnaire. Sexual satisfaction. Timepoint: Before the intervention- 8 weeks after intervention. Method of measurement: Larson sexual satisfaction questionnaire. Sexual desire. Timepoint: Before intervention- 8 weeks after intervention. Method of measurement: Female sexual function index questionnaire. Sexual arousal. Timepoint: Before intervention- 8 weeks after intervention. Method of measurement: Female sexual function index questionnaire. Vaginal Lubrication. Timepoint: Before intervention- 8 weeks after intervention. Method of measurement: Female sexual function index questionnaire. Orgasm. Timepoint: Before intervention- 8 weeks after intervention. Method of measurement: Female sexual function index questionnaire. Dyspareunia. Timepoint: Before intervention- 8 weeks after intervention. Method of measurement: Female sexual function index questionnaire. Sexual pleasure. Timepoint: Before intervention- 8 weeks after intervention. Method of measurement: Female sexual function index questionnaire. Ahvaz University of Medical Sciences Approved 2018-06-09 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Faculty of Nursing and Midwifery Ahvaz Jundishapur, Esfand Ave, Golestan Blvd, Ahvaz, Khuzestan Ahvaz Khouzestan Iran (Islamic Republic of)