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IRCT20240221061076N1 IRCT 2024-03-02 Shahid Beheshti University of Medical Sciences the effectiveness of the continuous care model in patients with bladder cancer Investigating the effectiveness of the continuous care model on quality of life, sexual function and sexual satisfaction of bladder cancer patients undergoing tumor removal surgery 2024-03-02 anticipated 58 Complete https://irct.ir/trial/75694 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive. N/A Bladder Cancer. Intervention 1: Intervention group: Intervention group: 1. In the familiarization phase, the first session will be held during a 30-40 minute session with the presence of the patient and his family. This step will be done the day before the patient's surgery (when the patient is admitted to the hospital for the first time). At this stage, the researcher, the patient and his family will get to know each other and express their expectations and emphasize the necessity of not interrupting the care relationship. The actions of this stage of the intervention include introducing the nurse to the patient and the family and completing the checklist of demographic status, quality of life, sexual satisfaction, women's sexual function and erectile dysfunction, clarifying the expectations of the patient and his family, completing the informed consent form, determining the agreement on times Face-to-face, telephone and virtual meetings and how communication is possible. 2. In the sensitization phase, according to the follow-up care model, the next meeting will be held in order to sensitize and involve the patient and family in the matter of care and follow-up, which will be held at the place of the research (hospital) and with prior coordination with the patients and their families. It will take 90 to 120 minutes to examine and pay attention to the care axes and all educational-care needs of the patients. This step will be done two days after surgery. The content of the educational program will be adjusted based on the latest articles and books and consultation with expert professors. The purpose of this stage is to teach information related to the familiarity with the disease, the nature of bladder cancer and tumor removal surgeries as far as the patient and their family understand, the importance of following the medication regimen, the importance of performing permitted physical activity, the importance of quitting smoking, how to perform dressings and Wound care, the need to reduce stress and mental pressure and ways to overcome it, teaching proper sexual positions and teaching how to have sex are performed with attention to surgery. This session will be conducted as face-to-face training. The mentioned interventions are during the hospitalization of the patients in the hospital and continue at home after discharge. At the end of the session, the educational package including self-care booklets will be provided to the patients and their families. This stage will only take place in the intervention group. 3. In the control phase, the goal of this phase is to continue the process of implementing the follow-up care model, because the most suitable programs without control and follow-up will be forgotten with the passage of time. A week after discharge, questionnaires on sexual satisfaction, quality of life, women's sexual performance and erectile dysfunction will be taken again. The continuous follow-up of patients after discharge from the hospital is based on the educational and self-care needs of the patients, and the researcher agrees with the patients and their families that after discharge and at home they encountered any problems and questions through phone calls, video calls or Seek solutions by sending messages in cyberspace. For 3 months, follow-up care in the form of phone calls, video and virtual pages (messages, videos and training photos will also be sent in this way) according to care needs, frequently with the aim of checking the care process and how They, checking and paying attention to care issues and problems are implemented. 4. The evaluation stage is proposed as the final step of follow-up care, but it will be taken into account and current in all stages, and finally, after 3 months of the implementation of the collection model, the collection model of the quality of life and sexual satisfaction questionnaires will be completed again by the patients. became. The data will be analyzed using statistical tests. Intervention 2: Control group: Control group: In this group, the familiarization phase will be carried out in the same way as the intervention group, but it is different from the point of view of time and the type of expectations of the next programs. Because the purpose of familiarization for the control group is to encourage them to cooperate and complete the desired data. At this stage, questionnaires on sexual satisfaction, quality of life, women's sexual performance and erectile dysfunction will be completed. The center's routine nursing care including taking vital signs, how to change dressings, post-surgery care, how to take medicines and the amount of activity allowed will be explained to the patient by the staff. Patients' numbers will be taken and a week after discharge, questionnaires on sexual satisfaction, quality of life, women's sexual performance and erectile dysfunction will be provided to patients for completion. In the meantime, no training will be given to the patients and only questionnaires will be given to the patients to complete. At the end of three months, the questionnaires will be provided to the patients for completion. After the end of the internship, flowcharts and educational resources will be provided to the patients. 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 There is no further information.
public Fateme Rezaeeniya
Faculty of Nursing and Midwifery, in front of Shahid Rajaei Heart Hospital, Valiasr St, Niayesh Blvd
Tehran Iran (Islamic Republic of) 1996835119 +98 21 8820 2518 fatemerezaeeniyanu@gmail.com Shahid Beheshti University of Medical Sciences scientific Soolmaz Moosavi
Faculty of Nursing and Midwifery, in front of Shahid Rajaei Heart Hospital, Hashemi Rafsanjani Blvd, Vali Asr St
Tehran Iran (Islamic Republic of) 1996835119 +98 21 8865 5366 moosavi.soolmaz@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) The patients include both men and women and are over 18 years of age. Patients have not performed two or more surgeries at the same time. Patients have sexual partners. 18 years no limit Both Failure to complete the care period Patients with previous sexual disorders based on the diagnosis of the attending physician Deterioration of the patient's condition, death of the patient, lack of access of the researcher to the samples, or any condition that makes it impossible for the samples to participate in the research. D09.0 Carcinoma in situ of bladder Rehabilitation Rehabilitation Intervention group: Intervention group: 1. In the familiarization phase, the first session will be held during a 30-40 minute session with the presence of the patient and his family. This step will be done the day before the patient's surgery (when the patient is admitted to the hospital for the first time). At this stage, the researcher, the patient and his family will get to know each other and express their expectations and emphasize the necessity of not interrupting the care relationship. The actions of this stage of the intervention include introducing the nurse to the patient and the family and completing the checklist of demographic status, quality of life, sexual satisfaction, women's sexual function and erectile dysfunction, clarifying the expectations of the patient and his family, completing the informed consent form, determining the agreement on times Face-to-face, telephone and virtual meetings and how communication is possible. 2. In the sensitization phase, according to the follow-up care model, the next meeting will be held in order to sensitize and involve the patient and family in the matter of care and follow-up, which will be held at the place of the research (hospital) and with prior coordination with the patients and their families. It will take 90 to 120 minutes to examine and pay attention to the care axes and all educational-care needs of the patients. This step will be done two days after surgery. The content of the educational program will be adjusted based on the latest articles and books and consultation with expert professors. The purpose of this stage is to teach information related to the familiarity with the disease, the nature of bladder cancer and tumor removal surgeries as far as the patient and their family understand, the importance of following the medication regimen, the importance of performing permitted physical activity, the importance of quitting smoking, how to perform dressings and Wound care, the need to reduce stress and mental pressure and ways to overcome it, teaching proper sexual positions and teaching how to have sex are performed with attention to surgery. This session will be conducted as face-to-face training. The mentioned interventions are during the hospitalization of the patients in the hospital and continue at home after discharge. At the end of the session, the educational package including self-care booklets will be provided to the patients and their families. This stage will only take place in the intervention group. 3. In the control phase, the goal of this phase is to continue the process of implementing the follow-up care model, because the most suitable programs without control and follow-up will be forgotten with the passage of time. A week after discharge, questionnaires on sexual satisfaction, quality of life, women's sexual performance and erectile dysfunction will be taken again. The continuous follow-up of patients after discharge from the hospital is based on the educational and self-care needs of the patients, and the researcher agrees with the patients and their families that after discharge and at home they encountered any problems and questions through phone calls, video calls or Seek solutions by sending messages in cyberspace. For 3 months, follow-up care in the form of phone calls, video and virtual pages (messages, videos and training photos will also be sent in this way) according to care needs, frequently with the aim of checking the care process and how They, checking and paying attention to care issues and problems are implemented. 4. The evaluation stage is proposed as the final step of follow-up care, but it will be taken into account and current in all stages, and finally, after 3 months of the implementation of the collection model, the collection model of the quality of life and sexual satisfaction questionnaires will be completed again by the patients. became. The data will be analyzed using statistical tests. Control group: Control group: In this group, the familiarization phase will be carried out in the same way as the intervention group, but it is different from the point of view of time and the type of expectations of the next programs. Because the purpose of familiarization for the control group is to encourage them to cooperate and complete the desired data. At this stage, questionnaires on sexual satisfaction, quality of life, women's sexual performance and erectile dysfunction will be completed. The center's routine nursing care including taking vital signs, how to change dressings, post-surgery care, how to take medicines and the amount of activity allowed will be explained to the patient by the staff. Patients' numbers will be taken and a week after discharge, questionnaires on sexual satisfaction, quality of life, women's sexual performance and erectile dysfunction will be provided to patients for completion. In the meantime, no training will be given to the patients and only questionnaires will be given to the patients to complete. At the end of three months, the questionnaires will be provided to the patients for completion. After the end of the internship, flowcharts and educational resources will be provided to the patients. Quality of Life. Timepoint: At the beginning of the study (before the start of the intervention), two weeks after surgery, three months after the intervention. Method of measurement: Aaronson quality of life questionnaire for cancer patients. Sexual satisfaction. Timepoint: At the beginning of the study (before the start of the intervention), two weeks after surgery, three months after the intervention. Method of measurement: Larson sexual satisfaction questionnaire. Male sexual function. Timepoint: At the beginning of the study (before the start of the intervention), two weeks after surgery, three months after the intervention. Method of measurement: Questionnaire of the International Index of Erectile Function. Women's sexual performance. Timepoint: At the beginning of the study (before the start of the intervention), two weeks after surgery, three months after the intervention. Method of measurement: Rozen Women's Sexual Performance Questionnaire. Shahid Beheshti University of Medical Sciences Approved 2024-02-12 Ethics committee in research of pharmacy, nursing and midwifery faculties of Shahid Beheshti Univers Faculty of Nursing and Midwifery, in front of Shahid Rajaei Heart Hospital, Hashemi Rafsanjani Blvd, Vali Asr St Tehran Tehran Iran (Islamic Republic of)