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IRCT20261017071464N1 IRCT 2026-10-25 Hamedan University of Medical Sciences Comparing the Effectiveness of Dignity Therapy Versus Usual Supportive Psychological Care in Reducing Demoralization and Improving Quality of Life in Patients with Limb Amputation: A Randomized Clinical Trial Comparing the Effectiveness of Dignity Therapy Versus Usual Supportive Psychological Care in Reducing Demoralization and Improving Quality of Life in Patients with Limb Amputation: A Randomized Clinical Trial 2026-10-23 anticipated 60 Recruiting https://irct.ir/trial/94188 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The study participants will be randomly assigned to two groups, A and B, using block randomization with a block size of 4. Randomization will be performed using an envelope containing four slips of paper, two labeled A and two labeled B. For each patient, one slip will be drawn to determine group allocation. The selected slip will not be returned to the envelope until all four slips have been drawn. After the allocation of the first four patients, all four slips will be returned to the envelope, and the same procedure will be repeated for each subsequent block of four patients until the required sample size is reached. Patients in Group A will receive dignity therapy, while patients in Group B will receive supportive psychological care. N/A Patients with limb amputation. Intervention 1: Intervention Group (Dignity Therapy): Dignity therapy is a brief psychotherapeutic intervention designed to enhance a sense of worth, meaning, and purpose in life and to reduce psychosocial and existential distress. The intervention will consist of three sessions. In the first session, a trained therapist will explain the goals of the therapy and the interview process to the patient and introduce the dignity therapy questions. In the second session, approximately 24–48 hours later, a semi-structured interview lasting approximately 60 minutes will be conducted, focusing on the patient’s life history, meaningful memories, accomplishments, values, hopes, and messages they wish to leave for their loved ones. The interview will be audio-recorded, transcribed, and compiled into a written document known as a generativity document. In the final session, the document will be presented to the patient for review and approval. After incorporating any requested revisions, the finalized document will be provided to the patient, who may share it with family members and loved ones if desired. At the end of the intervention, the study questionnaires will be administered again. Intervention 2: Control Group: Patients assigned to Group B, who will receive usual supportive psychological care, will have access to the full range of supportive services available to all study participants, including specialist physicians and nurses (i.e., professionals trained in providing supportive psychological care), social workers, and psychologists or psychiatrists. This will ensure that the necessary resources are available to address the physical, existential, and psychosocial needs of patients and their families. Healthcare professionals providing these services will address patients’ current concerns and problems but will not focus on enhancing their sense of legacy. In other words, a structured intervention comparable to dignity therapy will not be provided to patients randomly assigned to this group. Patients will be asked to complete the study questionnaires immediately after allocation to Group B and again after receiving usual supportive psychological care. 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 There is no further information.
public Sina Ghasemi
Hamadan University of Medical Sciences, Shahid Fahmideh Boulevard, Pajouhesh Square, Hamadan, Iran
hamadan Iran (Islamic Republic of) ۶۵۱۷۸۳۸۷۳۶ +98 901 669 0780 sinaghasemi19980@gmail.com Hamedan University of Medical Sciences scientific Sina Ghasemi
Hamadan University of Medical Sciences, Shahid Fahmideh Boulevard, Pajouhesh Square, Hamadan, Iran
hamadan Iran (Islamic Republic of) ۶۵۱۷۸۳۸۷۳۶ +98 901 669 0780 sinaghasemi19980@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Patients who underwent amputation during the study period Ability to read and speak Persian Obtaining Written Informed Consent 18 years no limit Both Individuals with cognitive disorders, such as dementia and delirium. Patients who were too ill to meet the study requirements Severe neurological disorder (the severity of the illness and neurological disorder will be assessed based on the physician’s judgment). Y83.5 Amputation of limb(s) Other Other Intervention Group (Dignity Therapy): Dignity therapy is a brief psychotherapeutic intervention designed to enhance a sense of worth, meaning, and purpose in life and to reduce psychosocial and existential distress. The intervention will consist of three sessions. In the first session, a trained therapist will explain the goals of the therapy and the interview process to the patient and introduce the dignity therapy questions. In the second session, approximately 24–48 hours later, a semi-structured interview lasting approximately 60 minutes will be conducted, focusing on the patient’s life history, meaningful memories, accomplishments, values, hopes, and messages they wish to leave for their loved ones. The interview will be audio-recorded, transcribed, and compiled into a written document known as a generativity document. In the final session, the document will be presented to the patient for review and approval. After incorporating any requested revisions, the finalized document will be provided to the patient, who may share it with family members and loved ones if desired. At the end of the intervention, the study questionnaires will be administered again. Control Group: Patients assigned to Group B, who will receive usual supportive psychological care, will have access to the full range of supportive services available to all study participants, including specialist physicians and nurses (i.e., professionals trained in providing supportive psychological care), social workers, and psychologists or psychiatrists. This will ensure that the necessary resources are available to address the physical, existential, and psychosocial needs of patients and their families. Healthcare professionals providing these services will address patients’ current concerns and problems but will not focus on enhancing their sense of legacy. In other words, a structured intervention comparable to dignity therapy will not be provided to patients randomly assigned to this group. Patients will be asked to complete the study questionnaires immediately after allocation to Group B and again after receiving usual supportive psychological care. Demoralization (Existential Distress). Timepoint: Before the intervention and after the completion of the intervention. Method of measurement: Use of questionnaire scores. Quality of Life. Timepoint: Before the intervention and after the completion of the intervention. Method of measurement: Use of questionnaire scores. Hamedan University of Medical Sciences Approved 2026-10-19 Research Ethics Committee of Hamadan University of Medical Sciences Hamadan University of Medical Sciences, Shahid Fahmideh Boulevard, Pajouhesh Square, Hamadan, Iran hamadan Hamadan Iran (Islamic Republic of)