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Study aim:
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