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IRCT20150608022609N8 IRCT 2020-07-02 Mazandaran University of Medical Sciences The effect of supportive program on sexual self-concept of women with breast cancer The effect of Social Network-Based Supportive Program (Whats App) on the sexual self-concept of women with breast cancer 2020-05-20 anticipated 60 Complete https://irct.ir/trial/46161 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: In this study, the first outcome is the impact of a social network-based support program (Whats App) on the sexual self-concept of women with breast cancer. As a secondary outcome of this study, the quality of sexual life of women with breast cancer will also be measured. Also, the clients' satisfaction questionnaire from counseling will be measured, Randomization description: After completing the informed consent form, the eligible individuals will receive an explanation about the purpose of the study and its importance. Then the Depression, Anxiety and Stress Questionnaire (DASS-21) will be administrated to participants and the one with 15 or higher score for the depression scale and 13 and above for the anxiety scale and 18 and above for the stress scale will be excluded from the study. They will be provided with additional information on how to study and randomly assign to the control and intervention groups. Also, In terms of ethics, there will be an opportunity to answer possible questions for participants, who are not eligible to continue and if necessary, they will be advised to refer to medical centers. Then, 60 eligible patients will be randomly divided into two groups. In this way, using computer software and based on the Permuted block randomization method, using 4 and 6 blocks between the numbers one to 60, two groups of A and group B will be determined. According to the statistical consultant, numbers from 1 to 60 were written on 60 envelopes, and the names of the groups were included in the each envelope according to the computer program. Patients will be randomly selected by the researcher according to the envelope and they will be randomly selected in one of the two intervention or control groups. N/A Breast cancer. Intervention 1: Intervention group: The social network-based support program (Whats App) will be implemented in 8 sessions, 2 sessions of 45 minutes per week. Each session is dedicated to the roll call and introduction of participants in the first 10 minutes. Then listening to the pre-prepared voice file in 20 minutes. After that, there will be 15 minutes for possible questions and answers. In addition, at the end of the sessions, participants are given a series of homework assignments that they must prepare for the next session and send to the personal account of the researcher in Whats App. The summary of the sessions is as follows: The first session : providing information about breast cancer, the effects of breast cancer on patients' lives and sexual self-concept, second session: training anatomy and sex cycle in men and women, third session includes: providing information about misconceptions and replacing them with correct concepts, fourth: strengthening Self-confidence and self-esteem in sexual intercourse, fifth session includes: teaching how to deal with shame in sexual intercourse and deciding to solve it and body image, sixth session: teaching the technique of sensory focus and explaining how to complete the session self-assessment form, session 7 includes: teaching strategies to enhance marital satisfaction and expressing feelings and opinions about sexual behavior, eighth session includes: training problem-solving skills and acceptance of supportive relationships. At the end of 8 sessions of intervention and 1 month later for follow-up, Snell's Multidimensional Sexual Self-Concept Questionnaire (MSSCQ), Rosen’s The Female Sexual Function Index Questionnaire (FSFI), Body Image Scale (BIS), The sexual quality of life-female Questionnaire (SQOL-F) and Customer Satisfaction Questionnaire (CSQ-8) will be completed by the intervention group by Porss Line. Intervention 2: Control group:The control group will also receive audio and video files in 8 sessions that no related to sexual self-concept. This group will complete the questionnaires again 4 weeks after completing the initial questionnaire and 1 month later. 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 The research is not over yet.
public Seyedeh Fatemeh Hamidi
Azadi Street- Nehzat Street- Imam Square
Sari Iran (Islamic Republic of) 4814864664 +98 11 3339 8858 Fateme.hamidi7575@gmail.com Mazandaran University of Medical Sciences scientific Zohreh Shahhosseni
Nasibeh Nursing And Midwifery faculty, Vesal Shirazi Street
Sari Iran (Islamic Republic of) 4816715793 +98 11 3337 4750 Zshahhosseni@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Being Iranian, At least primary education, Married women of childbearing age, One week after the last course of treatment (radiotherapy), Stage 1 to 3 of the disease, Living with a spouse for the past 4 weeks , No history of adverse event (such as death of a family member and severe accident) in the last 3 months, Failure to attend sexual health-related classes in the last 6 months, No depression, anxiety and severe stress according to the DASS-21 questionnaire, Satisfaction with participating in the research. no limit no limit Female Absence of more than 2 sessions in intervention meetings, Exacerbation of the disease (occurrence of new metastases), Occurrence of an adverse event (death of family members or accident leading to disability and divorce) during the study and until follow-up, Severe complications caused by radiotherapy, failure to continue cooperation in completing the questionnaire. c50 Malignant neoplasm of breast Other N/A Intervention group: The social network-based support program (Whats App) will be implemented in 8 sessions, 2 sessions of 45 minutes per week. Each session is dedicated to the roll call and introduction of participants in the first 10 minutes. Then listening to the pre-prepared voice file in 20 minutes. After that, there will be 15 minutes for possible questions and answers. In addition, at the end of the sessions, participants are given a series of homework assignments that they must prepare for the next session and send to the personal account of the researcher in Whats App. The summary of the sessions is as follows: The first session : providing information about breast cancer, the effects of breast cancer on patients' lives and sexual self-concept, second session: training anatomy and sex cycle in men and women, third session includes: providing information about misconceptions and replacing them with correct concepts, fourth: strengthening Self-confidence and self-esteem in sexual intercourse, fifth session includes: teaching how to deal with shame in sexual intercourse and deciding to solve it and body image, sixth session: teaching the technique of sensory focus and explaining how to complete the session self-assessment form, session 7 includes: teaching strategies to enhance marital satisfaction and expressing feelings and opinions about sexual behavior, eighth session includes: training problem-solving skills and acceptance of supportive relationships. At the end of 8 sessions of intervention and 1 month later for follow-up, Snell's Multidimensional Sexual Self-Concept Questionnaire (MSSCQ), Rosen’s The Female Sexual Function Index Questionnaire (FSFI), Body Image Scale (BIS), The sexual quality of life-female Questionnaire (SQOL-F) and Customer Satisfaction Questionnaire (CSQ-8) will be completed by the intervention group by Porss Line. Control group:The control group will also receive audio and video files in 8 sessions that no related to sexual self-concept. This group will complete the questionnaires again 4 weeks after completing the initial questionnaire and 1 month later. Sexual self-concept measurement. Timepoint: Before, immediately after the intervention and a month later. Method of measurement: Multidimensional Sexual Self-concept Questionnaire. Sexual quality of life. Timepoint: Before, immediately after the intervention and a month later. Method of measurement: Women's Sexual quality of life Questionnaire, higher scores indicate better quality of life. Client Satisfaction. Timepoint: Immediately after the intervention and a month later. Method of measurement: Client Satisfaction Questionnaire. Sari University of Medical Sciences Approved 2020-05-12 Ethics Committee of Mazandaran University Of Medical Sciences Deputy Of Research And Technology Of Mazandaran University Of Medical Sciences, Moallem Square, Moallem Street Sari Mazandaran Iran (Islamic Republic of)