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IRCT20251011067591N1 IRCT 2025-10-31 Shahre-kord University of Medical Sciences Communication therapy in chronic renal failure The Effect of Communication Therapy Based on the Peplau Model on Sense of Coherence and Psychological Well-Being in People Suffering from Chronic Renal Failure Undergoing Hemodialysis Referred to Hajar Hospital in Shahrekord 2024-07-10 anticipated 70 Complete https://irct.ir/trial/86857 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Participants were then randomly assigned to either the intervention or control group using a card-based random allocation rule. For this purpose, 70 cards were prepared—35 red cards for the intervention group (assigned to even-numbered dialysis days) and 35 yellow cards for the control group (assigned to odd-numbered days). All cards were placed into a container. Each eligible participant randomly drew a card from the container and was assigned to the corresponding group based on the color of the card. N/A Chronic Kidney Disease. Intervention 1: The intervention is designed based on Peplau’s Interpersonal Relations Model and is delivered in the inpatient dialysis unit. Sessions take place before or after dialysis treatments with a frequency of three times per week and 2–3 days between sessions, so that the complete intervention is delivered within three weeks for each participant. This schedule reduces patient fatigue, eliminates the need for additional clinic visits, and provides sufficient time for reflection and application of strategies between sessions.The intervention consists of seven individual sessions:Orientation Phase (1 session, 20–30 minutes)Introduction of the researcher and explanation of the intervention goalsInitial assessment including medical history, previous dialysis experiences, patient knowledge about the disease and treatment, support systems, and key concernsExplanation of required actions, physical setting, and available resourcesClarification of patient expectations from the healthcare team and establishment of trustIdentification Phase (1 session, 30–40 minutes, with a psychologist present)Encouragement of patients to express emotions and concernsCollection of psychological and physical data, including blood pressure, weight, dietary habits, and fluid intakeIdentification of care barriers and problems related to the disease and treatmentCompilation of a problem list and determination of an appropriate supportive care plan for each patientPromotion of belonging, self-efficacy, and reduction of helplessnessExploitation Phase (3 sessions, 40 minutes each)Implementation of a care plan tailored to each patient’s psychological well-being and Sense of CoherenceUse of educational tools, including brochures, visual charts, and digital resourcesActive support to help patients achieve independence in disease managementTermination Phase (2 sessions, 20–30 minutes each)Evaluation of goal attainment, effectiveness of interventions, and observed emotional and behavioral changesReview of the therapeutic communication process and planning of ongoing supportAn optional eighth session is reserved for clinical need to ensure all patients reach their therapeutic goals and maintain fidelity to the intervention. Intervention 2: Control group: Patients with chronic renal failure undergoing hemodialysis who received only their routine treatment. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to the confidentiality of patient information and the limitation of the data to the objectives of the present study, there is no plan to share the individual participant data (IPD).
public Fatemeh Tahmasebidehkordi
No.9,Shariati St
Shahrekord Iran (Islamic Republic of) 8815865489 +98 38 3334 7986 tahmasebii77@gmail.com Shahre-kord University of Medical Sciences scientific Fatemeh Tahmasebidehkordi
No9, Shariati Street, Shahrekord
Shahrekord Iran (Islamic Republic of) 8815865489 +98 38 3334 7986 tahmasebii77@gmail.com Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Informed consent of the patient indicating willingness to participate in the intended intervention Definitive diagnosis of ESRD confirmed by a nephrology specialist The patient’s age is equal to or greater than 18 years history of hemodialysis for at least 6 months the patient’s ability to learn 18 years no limit Both Patients with unstable physical conditions or those admitted to intensive care units Patients who are simultaneously enrolled in other clinical studies Patients with severe hearing or speech impairments that interfere with participation in therapeutic communication sessions. N18.4 Chronic kidney disease, stage 4 (severe) Other Other The intervention is designed based on Peplau’s Interpersonal Relations Model and is delivered in the inpatient dialysis unit. Sessions take place before or after dialysis treatments with a frequency of three times per week and 2–3 days between sessions, so that the complete intervention is delivered within three weeks for each participant. This schedule reduces patient fatigue, eliminates the need for additional clinic visits, and provides sufficient time for reflection and application of strategies between sessions.The intervention consists of seven individual sessions:Orientation Phase (1 session, 20–30 minutes)Introduction of the researcher and explanation of the intervention goalsInitial assessment including medical history, previous dialysis experiences, patient knowledge about the disease and treatment, support systems, and key concernsExplanation of required actions, physical setting, and available resourcesClarification of patient expectations from the healthcare team and establishment of trustIdentification Phase (1 session, 30–40 minutes, with a psychologist present)Encouragement of patients to express emotions and concernsCollection of psychological and physical data, including blood pressure, weight, dietary habits, and fluid intakeIdentification of care barriers and problems related to the disease and treatmentCompilation of a problem list and determination of an appropriate supportive care plan for each patientPromotion of belonging, self-efficacy, and reduction of helplessnessExploitation Phase (3 sessions, 40 minutes each)Implementation of a care plan tailored to each patient’s psychological well-being and Sense of CoherenceUse of educational tools, including brochures, visual charts, and digital resourcesActive support to help patients achieve independence in disease managementTermination Phase (2 sessions, 20–30 minutes each)Evaluation of goal attainment, effectiveness of interventions, and observed emotional and behavioral changesReview of the therapeutic communication process and planning of ongoing supportAn optional eighth session is reserved for clinical need to ensure all patients reach their therapeutic goals and maintain fidelity to the intervention. Control group: Patients with chronic renal failure undergoing hemodialysis who received only their routine treatment Sense of coherence. Timepoint: At the beginning of the study (before the intervention), immediately after the intervention, and two months later. Method of measurement: the 13-item short form of Antonovsky’s Sense of Coherence questionnaire. Psychological Well-Being. Timepoint: At the beginning of the study (before the intervention), immediately after the intervention, and two months later. Method of measurement: 18-item short form of the Psychological Well-Being questionnaire. Shahre-kord University of Medical Sciences Approved 2024-06-30 the ethics committee of Shahrekord University of Medical Sciences No. 9, Shariati St Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)