]>
IRCT20220704055367N2 IRCT 2022-09-10 Karaj University of Medical Sciences The effect of Psycho-spiritual approach in women with type 2 diabetes PSA (Psycho-Spiritual Approach) Investigating the effect of of Psycho-spiritual approach in improving sexual performance, sleep quality and depression in women with type 2 diabetes: randomized clinical trial 2022-10-22 anticipated 60 Complete https://irct.ir/trial/65365 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to select the sample, after preparing a list of type 2 diabetes patients who referred to the diabetes clinic of Shahid Rajaei Alborz Hospital, they will be contacted. Then, 60 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 30 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 30 will be considered. In order to implement this method, jerrydallal.com/random/assign.htm 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. 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 They will be, 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 Type 2 diabetes. Intervention 1: Intervention group: It will be formed in the intervention group in order to create group coordination in WhatsApp. Group meetings will be held in groups of 30 people. In order to implement the psycho-spiritual approach in the intervention group, 10 sessions of 45-90 minutes each week will be held by a psychologist and a psycho-nurse with experience in the field of psycho-spiritual approach and with the coordination of patients in a group. Considering that the conditions of diabetic 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 still, a decision will be made according to the conditions of the patients in this field. The spiritual approach is written by 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 the Baqiyatullah University of Medical Sciences and the Medicine and Religion Research Center, will be implemented. Also, the psychological approach will be implemented using the content of the group psychotherapy book (theoretical and practical basics) by Yalom and Lashech translated by Mahshid Yasai. The first session is for familiarization and introduction, sessions 2 to 4 are 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. 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 and medical centers and hospitals, 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 through e-mail (if possible to share information from a legal and ethical point of view, such as sharing the primary outcome of the study) To receive information, contact the following email address: fatemeh.abdi87@yahoo.com In the case of sending letter with regard to the current study, the following postal address of the corresponding author is available: School of nursing, Eshteraki street, Takhti Park, Baghestan BLVD How to obtain: Finding the responsible author's email, stating the reason, complying with ethical and legal issues; In this case, a quick response will be given to the requester. Comments:
public Fatemeh Abdi
School of nursing, Eshteraki street, Baghestan BLVD, Karaj, Iran
Karaj Iran (Islamic Republic of) 3146883811 +98 26 3433 6007 fatemeh.abdi87@yahoo.com Karaj University of Medical Sciences scientific Fatemeh Abdi
Taleghani Boulevard,Taleghani square, Karaj, Iran
Karaj Iran (Islamic Republic of) 3146883811 +98 26 3419 7000 fatemeh.abdi87@yahoo.com Karaj University of Medical Sciences Iran (Islamic Republic of) Married women aged 18 to 45 with type 2 diabetes Diagnosed with diabetes by a doctor and at least one year has passed since the diagnosis of diabetes Being interested in participating in the study Not having mental incompetence, including any kind of mental or cognitive disorder that prevents participation in the interaction process, adherence to the program, or giving informed consent to participate in this study Having Persian dialect 18 years 45 years Female Participating in unusual educational programs or similar research while conducting research Inability to continue participating in the study for any reason (need for special care, immigration, death) Failure to participate in all meetings E08 Diabetes mellitus due to underlying condition Treatment - Other Treatment - Other Intervention group: It will be formed in the intervention group in order to create group coordination in WhatsApp. Group meetings will be held in groups of 30 people. In order to implement the psycho-spiritual approach in the intervention group, 10 sessions of 45-90 minutes each week will be held by a psychologist and a psycho-nurse with experience in the field of psycho-spiritual approach and with the coordination of patients in a group. Considering that the conditions of diabetic 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 still, a decision will be made according to the conditions of the patients in this field. The spiritual approach is written by 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 the Baqiyatullah University of Medical Sciences and the Medicine and Religion Research Center, will be implemented. Also, the psychological approach will be implemented using the content of the group psychotherapy book (theoretical and practical basics) by Yalom and Lashech translated by Mahshid Yasai. The first session is for familiarization and introduction, sessions 2 to 4 are 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. Sexual performance scores on Female Sexual Function Index. Timepoint: Measurement of women's sexual performance scores at the beginning of the study, 10 weeks later, 22 weeks later. Method of measurement: Female Sexual Function Index. Sleep quality scores in the Pittsburgh Sleep Quality Index. Timepoint: Measurement of sleep quality score at the beginning of the study, 10 weeks later, 22 weeks later. Method of measurement: Pittsburgh Sleep Quality Index. Depression scores in Beck depression Inventory. Timepoint: Measurement of depression score at the beginning of the study, 10 weeks later, 22 weeks later. Method of measurement: Beck Depression Inventory. Patient's treatment compliance. Timepoint: Measurement of treatment compliance score at the beginning of the study, 10 weeks later, 22 weeks later. Method of measurement: Morisky Medication Adherence Scale. Karaj University of Medical Sciences Approved 2022-08-12 Research Ethics Committee of Alborz University of Medical Sciences Ethics committee office, Second floor, Safarian alley, 45 meters to Golshahr Karaj Alborz Iran (Islamic Republic of)