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IRCT20221114056495N1 IRCT 2023-02-10 Qazvin University of Medical Sciences Investigating the effect of implementing Levantal's self-regulation model on sexual function and satisfaction of women with diabetes in Qazvin city. Investigating the effect of implementing Levantal's self-regulation model on sexual function and satisfaction of women with diabetes in Qazvin city. 2023-02-25 anticipated 90 Complete https://irct.ir/trial/68411 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: After the registration of the eligible people in the study, after obtaining informed consent from the participants, the questionnaires will be provided to them, and explanations will be given regarding how to complete the questionnaire, emphasizing the confidentiality of the information. Each person will receive five questionnaires, which include demographic and fertility questionnaires; sexual performance questionnaire; Sexual satisfaction questionnaire, IPQ (Illness Perception Questionnaire) and diabetes severity index will be completed in both groups. relevant questionnaires; It will be completed by face-to-face interview.- To randomize the sample, a simple random block method with 4 blocks will be used. The participants of the research will be randomly divided into two intervention groups (consulting with Leventhal's self-regulation method) and the control group (without intervention). In the test group, the intervention based on Leventhal's self-regulation model will be implemented individually in three sessions. After the completion of the intervention, one month, two months and three months after the intervention, the questionnaire of understanding of the disease, sexual performance and sexual satisfaction will be completed again in both groups, Randomization description: For random allocation, given that there is an intervention method (consulting with the self-regulation method of Levantal) and two control and intervention groups, random allocation sequence generation software will be used to determine the allocation sequence using the quadruple block method. The four-block method is used to prevent significant imbalances in the number of participants assigned to each group. Block randomization ensures that there is no significant imbalance between groups at any time during randomization, and at certain points the number of participants in each group is equal. By using the randomization block balanced method, they will be placed in two test and control groups with blocks of four. In this way, by choosing 20 blocks out of 6 possible blocks from the quadruple combination of two test and control groups, the selection process is defined by default and the patients will be assigned to two groups respectively. 1-AABB/ 2-ABBA/ 3-BAAB/ 4-ABAB/ 5-BABA/ 6-BBAA. N/A Investigating the effect of implementing Levantal's self-regulation model on sexual function and satisfaction of women with diabetes in Qazvin city. Intervention 1: Intervention group: in the test group, in addition to receiving the usual care and training, their counseling needs are first determined and a counseling program is designed based on that. The educational content is based on the stages of Loenthal's self-regulation theory, before the intervention, questionnaires on demographic characteristics, sexual performance, sexual satisfaction, and understanding of the disease will be completed. Then the researcher will start the disease understanding intervention during three sessions of 60 to 90 minutes in three consecutive weeks face to face and individually in a private place. will be completed. Intervention 2: Control group: The control group only received the usual training and care that was given to the patients by the nurse, doctor, nutritionist and other members of the care team in the clinic according to the previous routine. In this group, questionnaires of demographic characteristics, sexual function and sexual satisfaction, understanding of the disease will be completed at the beginning of the study, one month, two months, and three months later. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts 6 months after the publication of the article results To whom: The data will be available only to researchers working in academic and scientific institutions Conditions: If the results of this study show the effectiveness of the method, this counseling method can be used to improve sexual performance and increase sexual satisfaction of diabetic women. Where to obtain: Valid databases How to obtain: 1- After obtaining approval from the Ethics Committee of Qazvin University of Medical Sciences, registering the project in the National System of Clinical Trials and obtaining the necessary permits, the diabetes clinic located in Qazvin city is referred to. 2- The samples will be selected from women with diabetes (type 1 and 2) referring to the diabetes clinic in Qazvin city. 3- In these centers, people with conditions to enter the study are identified and they are invited to participate in the study 4- About the importance and objectives of the research, information, having the freedom to participate in the study, is explained to the people who have the conditions to enter the study, and in line with the ethical principles of research, they are assured that their information will remain confidential. The questionnaires will be anonymous and only coded. After taking a written consent form and obtaining permission, the samples are included in the study. Also, the researcher undertakes that the subjects can withdraw from the study whenever they wish and will be explained to the participants about receiving services by participating or not participating in the study and to some extent about how to do the work. 5- After the registration of the eligible people in the study, after obtaining informed consent from the participants, the questionnaires will be provided to them and the explanation about how to complete the questionnaire will be done with emphasis on the confidentiality of the information. Each person will receive five questionnaires, which include demographic and fertility questionnaires; sexual performance questionnaire; Sexual satisfaction questionnaire, IPQ (Illness Perception Questionnaire) and diabetes severity index will be completed in both groups. relevant questionnaires; It will be completed by face-to-face interview. 6- To randomize the sample, a simple random block method with 4 blocks will be used. The participants of the research will be randomly divided into two intervention groups (consulting with Leventhal's self-regulation method) and the control group (without intervention). In the test group, the intervention based on Leventhal's self-regulation model will be implemented individually in three sessions. After the completion of the intervention, one month, two months and three months after the intervention, the questionnaire of understanding of the disease, sexual performance and sexual satisfaction will be completed again in both groups. 7- Analysis of findings: after the end of the data collection process, the analysis of findings will be done with statistical software. Comments:
public Leila Ghorbani
No. 59, No. 48, Imamzade Ebrahim St., Qom
ghazvin Iran (Islamic Republic of) 3717689483 +98 25 3890 3256 L.ghorbani25459@gmail.com Qazvin University of Medical Sciences scientific Leila Ghorbani
No. 59, No. 48, Imamzade Ebrahim St., Qom
Ghazvin Iran (Islamic Republic of) 3717689483 +98 25 3890 3256 L.ghorbani25459@gmail.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the study Age 15-49 years Living in Qazvin province At the time of study, be married and have sex Minimum literacy Ability to verbally communicate and answer questionnaire questions Having type 1 or type 2 diabetes according to expert opinion and laboratory factors (recorded in the medical record) not pregnant At least 6 months have passed since the diagnosis of diabetes 15 years 49 years Female Any physical illness with a doctor's approval in the person or partner that affects their sexual function or sexual satisfaction Taking any type of medicine that (according to the patient) is effective on the patient's sexual function. Participation in other sexual education or counseling sessions during the last month or at the beginning of the study The existence of marital problems that affect people's sexual relations. Patients with severe psychiatric disorders that require drug therapy (clinical and semi-clinical disorders) Other N/A Intervention group: in the test group, in addition to receiving the usual care and training, their counseling needs are first determined and a counseling program is designed based on that. The educational content is based on the stages of Loenthal's self-regulation theory, before the intervention, questionnaires on demographic characteristics, sexual performance, sexual satisfaction, and understanding of the disease will be completed. Then the researcher will start the disease understanding intervention during three sessions of 60 to 90 minutes in three consecutive weeks face to face and individually in a private place. will be completed Control group: The control group only received the usual training and care that was given to the patients by the nurse, doctor, nutritionist and other members of the care team in the clinic according to the previous routine. In this group, questionnaires of demographic characteristics, sexual function and sexual satisfaction, understanding of the disease will be completed at the beginning of the study, one month, two months, and three months later. Sexual performance and sexual satisfaction. Timepoint: Before the start of the intervention, after that one month, two months and three months after the intervention. Method of measurement: Demographic and Fertility Questionnaire, Sexual Function Questionnaire (FSFI), Sexual Satisfaction Questionnaire (SSS-W), Disease Perception Questionnaire (IPQ-R) and Diabetes Severity Index (DCSI). Determining and comparing the level of understanding of the disease in women with diabetes in the control and test groups before and after the intervention. Timepoint: Before the intervention, one month, two months and three months after the intervention. Method of measurement: Illness perception will be measured with the Illness Perception Questionnaire (IPQ-R). Qazvin University of Medical Sciences Approved 2023-02-05 Ethics committee of ghazvin University of Medical Sciences No. 59, No. 48, Imamzade Ebrahim St., Qom Ghazvin Qazvin Iran (Islamic Republic of)