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IRCT20240725062542N3 IRCT 2024-12-14 Qazvin University of Medical Sciences The Effect of Leventhal's Self-Regulatory Model on the Cognitive Emotion Regulation Strategies in Hemodialysis Patients The Effect of Leventhal's Self-Regulatory Model on the Cognitive Emotion Regulation Strategies in Hemodialysis Patients 2025-03-21 anticipated 56 Complete https://irct.ir/trial/80687 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Initially, eligible individuals will be selected based on accessibility. Then, for random allocation considering the two-group nature of the study, a randomization method with balanced blocks of size 4 will be employed. To determine the sequence of allocations using the 4-block method, online random allocation software (https://www.sealedenvelope.com/simple-randomiser/v1/lists) will be used. Group identification papers will be placed in sequentially ordered envelopes inside a sealed package to conceal the allocation sequence. This way, the questionnaire with the corresponding code will be assigned to the individual receiving code 1. N/A Chronic Kidney Disease. Intervention 1: Intervention group: The first educational intervention session begins with exploring patients' beliefs about their illness and perceptions of dialysis using simple, clear language without medical jargon, delivered in short sentences. The focus is on addressing misconceptions the patient may have about the illness. In the second session, after reviewing the previous session's topics, patients are educated on their prognosis, disease duration, treatment methods, complications, and prescribed medications. At the end of each session, a summary of the discussions is reviewed. The content of these sessions is prepared and organized under specialists' supervision, drawing from previous research and medical reference books. In addition to educational sessions, the intervention group will also receive one month of weekly follow-up telephone interventions conducted by the researcher. Call times are determined based on the patient's availability and consent. The content of these calls will focus on encouraging and reinforcing the healthy behaviors taught in the educational sessions, as well as addressing any questions and assessing patient progress within the framework of Leventhal's self-regulation model (identity, cause, timeline, consequences, control, and treatment). Intervention 2: Control group: In the control group, questionnaires are completed initially, immediately after the intervention, and 3 months post-intervention. At the end, a booklet containing educational points on the disease and points that should be observed during the disease is given to the patient. Yes - There is a plan to make this available What will be shared: All data collected will potentially be shareable after the participants have been de-identified. When: The data will be available 6 months after the study results have been published. To whom: The data will only be accessible to academic and research institutions researchers. Conditions: Researchers may use this study's results for future studies, provided that they obtain permission from the project coordinators. Where to obtain: Executors of the plan: Sima Kazemi (nurse.simakazemi@gmail.com) Mohammad Ali Soleimani (soleimany.msn@gmail.com) How to obtain: Please contact us via email for further communication. Comments:
public Sima Kazemi
Faculty of Nursing and Midwifery, Qazvin University of Medical Sciences, Bahonar Blvd, Qazvin, Iran
Qazvin Iran (Islamic Republic of) 59811-34197 +98 28 3333 6001 nurse.simakazemi@gmail.com Qazvin University of Medical Sciences scientific Mohammad Ali Soleimani
Faculty of Nursing and Midwifery, Qazvin University of Medical Sciences, Bahonar Blvd, Qazvin, Iran
Qazvin Iran (Islamic Republic of) 59811-34197 +98 28 3333 6001 soleimany.msn@gmail.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the research and complete the consent form Full consciousness and the ability to communicate People over 18 years old Being literate in reading and writing in the Persian language Starting Hemodialysis at least 3 months ago Access to a phone or mobile for follow-up 18 years no limit Both Diagnosis of a psychiatric disorder and use of psychotropic drugs (as diagnosed by a physician) Experience of spiritual crises in the last 6 months (self-report) Use of alcohol and drugs (self-report) N18.9 Chronic kidney disease, unspecified Behavior Behavior Intervention group: The first educational intervention session begins with exploring patients' beliefs about their illness and perceptions of dialysis using simple, clear language without medical jargon, delivered in short sentences. The focus is on addressing misconceptions the patient may have about the illness. In the second session, after reviewing the previous session's topics, patients are educated on their prognosis, disease duration, treatment methods, complications, and prescribed medications. At the end of each session, a summary of the discussions is reviewed. The content of these sessions is prepared and organized under specialists' supervision, drawing from previous research and medical reference books. In addition to educational sessions, the intervention group will also receive one month of weekly follow-up telephone interventions conducted by the researcher. Call times are determined based on the patient's availability and consent. The content of these calls will focus on encouraging and reinforcing the healthy behaviors taught in the educational sessions, as well as addressing any questions and assessing patient progress within the framework of Leventhal's self-regulation model (identity, cause, timeline, consequences, control, and treatment). Control group: In the control group, questionnaires are completed initially, immediately after the intervention, and 3 months post-intervention. At the end, a booklet containing educational points on the disease and points that should be observed during the disease is given to the patient. This is a score that each participant will receive based on the 18-item Cognitive Emotion Regulation Questionnaire (CERQ-2006). Timepoint: The Cognitive Emotion Regulation Strategies questionnaire will be administered at three different time points: before the intervention, immediately after the intervention, and three months post-intervention for follow-up. Method of measurement: This tool (CERQ-2006) measures the cognitive Emotion regulation strategies in response to life-threatening events. Qazvin University of Medical Sciences Approved 2024-12-11 Ethics Committee of Qazvin University of Medical Sciences Faculty of Nursing and Midwifery, Qazvin University of Medical Sciences, Bahonar Blvd, Qazvin, Iran Qazvin Qazvin Iran (Islamic Republic of)