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IRCT20220704055366N1 IRCT 2023-03-15 Shahid Beheshti University of Medical Sciences Integrated and population-based psycho-spiritual care package Evaluation of the effectiveness of integrated and population-based psycho-spiritual care package on self-efficacy and health-related quality of life in adults with cardiovascular disease 2023-04-21 anticipated 80 Complete https://irct.ir/trial/69099 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In order to select the sample, after preparing a list of cardiovascular patients referring to Imam Hossein hospital clinics, they will be contacted. Then, 80 people who wish to participate in the research will be selected using available sampling and will be included in the study based on the criteria for entering the research. And they will be randomly assigned to two groups of psycho-spiritual approach and control, each of which will have 40 participants. In order to randomize the samples, the block randomization method, which is a limited randomization method related to studies with groups with the same sample size, will be used. Also, in this study, according to the sample size, two blocks of 40 will be considered. In order to implement this method, https://www.sealedenvelpe.com will be used. And on the mentioned site, the title of the two groups (psycho-spiritual intervention and control), the number of blocks and the volume of each block will be mentioned, which includes two blocks of 40. Then, according to the randomization obtained from the site and the last three numbers of the patients' files, randomization will be done. In this way, in the face of the obtained randomizations, we will write down the last three numbers of the patients' files in order from the least to the most, and according to that, the patients in each of the control groups and the psycho-spiritual approach will be accepted, Blinding description: This study is a blinded clinical trial. Therefore, blinding will be implemented in the evaluators who will analyze the study data. For this purpose, the questionnaires that will be completed by the researchers in all three groups, in the form of a contract between the researchers. Also, it will be specified with one of the English letters above it, which questionnaire was completed by the participants of which of the study groups; However, the evaluators of the data analysis will not be aware of the English letter of agreement between the researchers assigned to each group. N/A Cardiovascular diseases. Intervention 1: Intervention group: he intervention group will be formed in order to create group coordination in a group approved by all members. Group meetings will be held in groups of 40 people. In order to implement the psycho-spiritual approach in the intervention group, 10 sessions of 45-90 minutes will be held every week by a psychologist and a psycho-nurse with experience in the field of psycho-spiritual approach and with the coordination of the patients in a group. Considering that the conditions of cardiovascular patients are special, it is difficult for them to participate in face-to-face classes. Therefore, they may not be able to participate in the class in person. In addition, if they gather in one place for training, some diseases may be transmitted and become a problem. Therefore, according to the mentioned cases, it was preferred that the training be virtual, but nevertheless, a decision will be made according to the conditions of the patients in this field. The spiritual approach is written using the content of the chapter on spiritual methods to relieve the pain of patients from the book of spiritual care. Dr. Mino Asadzandi, a member of the academic faculty of Baqiyatullah University of Medical Sciences and the Medicine and Religion Research Center, will be implemented. Also, the psychological approach will be implemented using the contents of the group psychotherapy book (theoretical and practical basics) by Yalom and Lashech translated by Mahshid Yasai. The first session will be designed for familiarization and introduction, sessions 2 to 4 will be designed for a spiritual approach, and sessions 5 to 10 will be designed for a psychological approach. Intervention 2: Control group: The control group will receive usual care such as pharmacotherapy. Yes - There is a plan to make this available What will be shared: Only part of the data, such as information related to the main outcome and general demographic information, can be shared. When: The access period starts 3 months after the results are published To whom: Doctors, nurses, midwives, researchers working in universities as well as medical centers and hospitals and clinical psychologists Conditions: In order to use it for scientific purposes and by mentioning the source used and requesting the journal in which the article will be published. Where to obtain: Communication via e-mail (if it is possible to share information from a legal and ethical point of view, such as sharing the primary result of the study) to receive information, contact the following e-mail address: Responsible author's e-mail: zare2121@gmail.com. If you need to write a letter, the following postal address of the responsible author is available: College of Nursing and Midwifery, Nyayesh-Vali Asr junction,Tehran, How to obtain: Finding the email of the responsible author, stating the reason, complying with ethical and legal issues; In this case, a quick response will be given to the requester. Comments:
public Mohammadamin Jandaghian-Bidgoli
Vali Asr-Nyayesh Junction
Tehran Iran (Islamic Republic of) 8741668551 +98 31 5472 0297 zare2121@gmail.com Shahid Beheshti University of Medical Sciences scientific Mohammadamin Jandaghian Bidgoli
Nurisng and midwifery school, Valiasr st.,Tehran
Tehran Iran (Islamic Republic of) 8741668551 +98 31 5472 0296 mohammadaminjandaghian@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Suffering from one of the types of cardiovascular diseases Being able to speak Persian Interest in the participation 18 years 65 years Both Suffering from psychiatric disorders Participation in other similar interventions R94.3 Abnormal results of cardiovascular function studies Treatment - Other Treatment - Other Intervention group: he intervention group will be formed in order to create group coordination in a group approved by all members. Group meetings will be held in groups of 40 people. In order to implement the psycho-spiritual approach in the intervention group, 10 sessions of 45-90 minutes will be held every week by a psychologist and a psycho-nurse with experience in the field of psycho-spiritual approach and with the coordination of the patients in a group. Considering that the conditions of cardiovascular patients are special, it is difficult for them to participate in face-to-face classes. Therefore, they may not be able to participate in the class in person. In addition, if they gather in one place for training, some diseases may be transmitted and become a problem. Therefore, according to the mentioned cases, it was preferred that the training be virtual, but nevertheless, a decision will be made according to the conditions of the patients in this field. The spiritual approach is written using the content of the chapter on spiritual methods to relieve the pain of patients from the book of spiritual care. Dr. Mino Asadzandi, a member of the academic faculty of Baqiyatullah University of Medical Sciences and the Medicine and Religion Research Center, will be implemented. Also, the psychological approach will be implemented using the contents of the group psychotherapy book (theoretical and practical basics) by Yalom and Lashech translated by Mahshid Yasai. The first session will be designed for familiarization and introduction, sessions 2 to 4 will be designed for a spiritual approach, and sessions 5 to 10 will be designed for a psychological approach. Control group: The control group will receive usual care such as pharmacotherapy. Quality of life score. Timepoint: Measuring the quality of life score at the beginning of the study, 10 weeks later, 22 weeks later. Method of measurement: The 36-Item Short Form Health Survey (SF-36). Self-efficacy. Timepoint: Measuring the quality of life score at the beginning of the study, 10 weeks later, 22 weeks later. Method of measurement: Sullivan’s cardiac self-efficacy scale. Shahid Beheshti University of Medical Sciences Approved 2022-08-09 Research Ethics Committees of School of Pharmacy and Nursing & Midwifery- Shahid Beheshti University In front of Rajaee Hospital, Valiasr-Niayesh Junction,Vali Asr St. Tehran Tehran Tehran Iran (Islamic Republic of)