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IRCT20130424013110N14 IRCT 2026-05-08 Tehran University of Medical Sciences Feasibility, Adaptability, Acceptability, and Effectiveness of Dignity Therapy in Patients with Heart Failure Feasibility, Adaptability, Acceptability, and Effectiveness of Dignity Therapy in Patients with Heart Failure: a mixed methods study 2026-05-15 anticipated 66 Complete https://irct.ir/trial/89876 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: For allocating participants to the intervention and control groups, a randomized block design with a fixed block size will be used. In this study, blocks with a size of 4 will be generated from the letters T and C (where these letters indicate the intervention and control groups). In each block, two participants are assigned to the intervention group and two participants are assigned to the control group. The allocation sequence within each block will be placed in a sealed packet and will be selected randomly, and the order of participants for allocation to the intervention or control group for each patient will be determined according to which block is selected, upon the start of the intervention for that patient, Blinding description: According to the intervention, blinding of patients, healthcare providers and outcome assessors is not possible. N/A Heart failure. Intervention 1: Intervention group: The intervention group receives the dignity therapy intervention over three sessions, with approximate intervals of 48 to 72 hours between them. Session 1: This session is conducted through a semi-structured interview within a time frame of 30 to 60 minutes, which may be extended depending on the flow of the interview. This session focuses on reviewing the patient’s life, identifying strengths, personal and professional achievements, and expressing future hopes and aspirations. The content of this session is recorded and documented at this stage. Session 2: This session involves reviewing and discussing the content prepared in the first session with the patient’s participation, and receiving feedback for final editing and making any necessary revisions. Session 3: This session involves the preparation and presentation of the final version as a lasting document to the patient and their family. Intervention 2: Control group: Participants in the control group will undergo monitoring and receive the routine treatments and care provided by the center. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It is not yet known if there will be a plan to make this available.
public Mehdi Harorani
Tehran University of Medical Sciences., School of Nursing and Midwifery., Dr. Mirkhani St (East Nosrat)., Towhid Sq.
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6692 7171 m.harorany@gmail.com Tehran University of Medical Sciences scientific Dr. Arpi Manookian
Tehran University of Medical Sciences., School of Nursing and Midwifery., Dr. Mirkhani St (East Nosrat)., Towhid Sq.
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6692 7171 ar-manookian@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Diagnosis of class II or III IV heart failure based on the New York Heart Association (NYHA) classification by a specialist physician Willingness and informed consent to participate in the study Absence of severe illness related conditions that would prevent participation in the intervention Mental health stability and no significant psychological issues such as severe anxiety and depression according to the patient’s medical records Age over 18 years and lower 65 years 18 years 65 years Both Patients with heart failure who have not completed the consent form. Participation in educational or therapeutic sessions similar to the intervention Any life threatening emergency situation I50 Heart failure Other Other Intervention group: The intervention group receives the dignity therapy intervention over three sessions, with approximate intervals of 48 to 72 hours between them. Session 1: This session is conducted through a semi-structured interview within a time frame of 30 to 60 minutes, which may be extended depending on the flow of the interview. This session focuses on reviewing the patient’s life, identifying strengths, personal and professional achievements, and expressing future hopes and aspirations. The content of this session is recorded and documented at this stage. Session 2: This session involves reviewing and discussing the content prepared in the first session with the patient’s participation, and receiving feedback for final editing and making any necessary revisions. Session 3: This session involves the preparation and presentation of the final version as a lasting document to the patient and their family. Control group: Participants in the control group will undergo monitoring and receive the routine treatments and care provided by the center. Spiritual Well-Being. Timepoint: Before and after intervention. Method of measurement: Spiritual Well-Being Scale (FACIT-sp-12). Hope level. Timepoint: Before and after intervention. Method of measurement: Herth Hope Index (HHI). Patient Dignity. Timepoint: Before and after intervention. Method of measurement: Patient Dignity questionnaire (Patient Dignity Inventory (PDI). Tehran University of Medical Sciences Approved 2025-11-24 Ethics Committee of the Faculty of Nursing, Midwifery, and Rehabilitation Central Building, Tehran University of Medical Sciences, Intersection of Qods Street, Keshavarz Boulevard, Secretariat of the Ethics Committee in Biomedical Research, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)