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IRCT20250714066482N1 IRCT 2025-07-15 Tehran University of Medical Sciences The Effect of Dignity Therapy on Quality of Life and Life Satisfaction in Patients with Heart Failure Investigating the Effect of In-Person and Virtual Dignity Therapy on Quality of Life and Life Satisfaction in Patients with Heart Failure 2025-08-05 anticipated 90 Complete https://irct.ir/trial/84773 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive. N/A Patients with heart failure. Intervention 1: Intervention group: In the in-person group, the intervention is carried out through a structured process consisting of three face-to-face sessions, each lasting 30 to 60 minutes, with intervals of 24 to 48 hours.In the first session, participants are introduced to the study and the Dignity Therapy interview framework. They are given the opportunity to reflect on the questions before the formal interview begins.In the second session, the researcher conducts an interview with the patient, asking specific questions to explore their life history, values, beliefs, and concerns in order to identify what matters most to them. With the participant’s consent, the interview is recorded using a voice recorder.After the second session, based on the information gathered, the researcher prepares a written narrative that includes the patient’s important memories, accomplishments, values, and messages for their family and loved ones.In the third session, the written narrative is reviewed together with the patient to ensure it accurately reflects their views and emotions. Any necessary revisions are made. Finally, the completed version is presented to the patient as a booklet and, if desired, to their family. Intervention 2: Intervention group: In the virtual group, the intervention is conducted through a structured process consisting of three individual sessions held via video calls, each lasting 30 to 60 minutes, with intervals of 24 to 48 hours.In the first session, participants are introduced to the study and the Dignity Therapy interview framework. They are given time to reflect on the questions before the formal interview begins.In the second session, the researcher conducts a virtual interview with the patient, asking specific questions to explore their life history, values, beliefs, and concerns in order to identify what matters most to them. With the participant’s consent, the interview is recorded using a voice recorder.After the second session, based on the collected information, the researcher prepares a written narrative that includes the patient’s meaningful memories, achievements, values, and messages for their family and loved ones.In the third session, the written narrative is reviewed with the patient to ensure that it accurately reflects their thoughts and feelings. Any necessary revisions are made. Finally, the finalized version is presented to the patient as a booklet and, if desired, to their family. Intervention 3: 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 No further information is available.
public Mahsa Khedmatizare
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 mahsa.khzare@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, III, or 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, depression, suicidal thoughts, obsessive-compulsive disorder, or other psychological disorders, according to the patient’s medical records Ability to use a smartphone and access the internet Adequate hearing and speaking abilities to participate in interviews Minimum literacy in reading and writing in Persian No cognitive impairments Age over 18 years 18 years no limit Both Lack of willingness to continue participation in the study Deterioration of the patient's health condition Participation in educational or therapeutic sessions similar to the intervention Death Re-hospitalization I50 Heart failure Other Other Other Intervention group: In the in-person group, the intervention is carried out through a structured process consisting of three face-to-face sessions, each lasting 30 to 60 minutes, with intervals of 24 to 48 hours.In the first session, participants are introduced to the study and the Dignity Therapy interview framework. They are given the opportunity to reflect on the questions before the formal interview begins.In the second session, the researcher conducts an interview with the patient, asking specific questions to explore their life history, values, beliefs, and concerns in order to identify what matters most to them. With the participant’s consent, the interview is recorded using a voice recorder.After the second session, based on the information gathered, the researcher prepares a written narrative that includes the patient’s important memories, accomplishments, values, and messages for their family and loved ones.In the third session, the written narrative is reviewed together with the patient to ensure it accurately reflects their views and emotions. Any necessary revisions are made. Finally, the completed version is presented to the patient as a booklet and, if desired, to their family. Intervention group: In the virtual group, the intervention is conducted through a structured process consisting of three individual sessions held via video calls, each lasting 30 to 60 minutes, with intervals of 24 to 48 hours.In the first session, participants are introduced to the study and the Dignity Therapy interview framework. They are given time to reflect on the questions before the formal interview begins.In the second session, the researcher conducts a virtual interview with the patient, asking specific questions to explore their life history, values, beliefs, and concerns in order to identify what matters most to them. With the participant’s consent, the interview is recorded using a voice recorder.After the second session, based on the collected information, the researcher prepares a written narrative that includes the patient’s meaningful memories, achievements, values, and messages for their family and loved ones.In the third session, the written narrative is reviewed with the patient to ensure that it accurately reflects their thoughts and feelings. Any necessary revisions are made. Finally, the finalized version is presented to the patient as a booklet and, if desired, to their family. Control group: Participants in the control group will undergo monitoring and receive the routine treatments and care provided by the center. ْQuality of life. Timepoint: Before intervention and one month after the end of intervention. Method of measurement: Chronic heart failure health-related quality of life questionnaire (CHFQOLQ-20). Life satisfaction. Timepoint: Before intervention and one month after the end of intervention. Method of measurement: Satisfaction With Life Scale (SWLS). Anxiety. Timepoint: Before the intervention and one month after the end of the intervention. Method of measurement: Generalized Anxiety Disorder (GAD-7). Tehran University of Medical Sciences Approved 2025-07-09 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)