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
Design
A randomized, parallel-group clinical trial with intervention and control groups, no blinding, and a total of 60 patients.
Settings and conduct
This randomized clinical trial will be conducted among patients with limb amputation at a hospital affiliated with Hamadan University of Medical Sciences. Given the nature of the interventions and participants’ awareness of the intervention they receive, the study will be conducted using an open-label design.
After collecting demographic information, two questionnaires will be used: the Missoula-VITAS Quality of Life Index and the Demoralization Scale (DS-II), using their Persian versions. Participants in both groups will complete these questionnaires before the intervention begins and after it is completed to assess and compare changes in the study variables between the two groups.
Participants/Inclusion and exclusion criteria
The inclusion criteria were: being at least 18 years of age, having undergone limb amputation during the study period, being able to read and speak Persian, and providing written informed consent.
The exclusion criteria were: cognitive disorders such as dementia or delirium; being too ill to meet the study requirements; having a severe neurological disorder (the severity of the illness and neurological disorder will be assessed based on the physician’s judgment); and unwillingness to continue participating in the study.
Intervention groups
Patients in Group A (the intervention group) will receive dignity therapy, while patients in Group B (the control group) will receive usual supportive psychological care.
Main outcome variables
Demoralization (Existential Despair) – Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20261017071464N1
Registration date:2026-10-25, 1405/08/03
Registration timing:registered_while_recruiting
Last update:2026-10-25, 1405/08/03
Update count:0
Registration date
2026-10-25, 1405/08/03
Registrant information
Name
Zahra Zeinolabedini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3493 4163
Email address
zahrazeinol@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-10-23, 1405/08/01
Expected recruitment end date
2026-11-22, 1405/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
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
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who underwent amputation during the study period
Ability to read and speak Persian
Obtaining Written Informed Consent
Exclusion criteria:
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).
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Boulevard, Pajouhesh Square, Hamadan, Iran
City
hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۸۴
Approval date
2026-10-19, 1405/07/27
Ethics committee reference number
IR.UMSHA.REC.1405.581
Health conditions studied
1
Description of health condition studied
Patients with limb amputation
ICD-10 code
Y83.5
ICD-10 code description
Amputation of limb(s)
Primary outcomes
1
Description
Demoralization (Existential Distress)
Timepoint
Before the intervention and after the completion of the intervention
Method of measurement
Use of questionnaire scores
2
Description
Quality of Life
Timepoint
Before the intervention and after the completion of the intervention
Method of measurement
Use of questionnaire scores
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Other
2
Description
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.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital, Hamadan, affiliated with Hamadan University of Medical Sciences
Full name of responsible person
Sina Ghasemi
Street address
Besat Specialized and Subspecialized Hospital, Shahid Beheshti Boulevard, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 901 669 0780
Email
sinaghasemi19980@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Alireza Soltanian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Boulevard, Pajouhesh Square, Hamadan, Iran
City
hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 901 669 0780
Email
sinaghasemi19980@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Sina Ghasemi
Position
Faculty Member – Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Boulevard, Pajouhesh Square, Hamadan, Iran
City
hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 901 669 0780
Email
sinaghasemi19980@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Sina Ghasemi
Position
Faculty Member – Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Boulevard, Pajouhesh Square, Hamadan, Iran
City
hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 901 669 0780
Email
sinaghasemi19980@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Sina Ghasemi
Position
Faculty Member – Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Boulevard, Pajouhesh Square, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 901 669 0780
Email
sinaghasemi19980@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available