The Effectiveness of Dignity Therapy in Terminal Ill Patients

NCT ID: NCT07150728

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-14
• Study Completion Date: 2025-08-25

Brief Summary

Maintaining patient dignity is the moral obligation and an important ethical consideration of health professionals; it is also the primary connotation of medical care. Previous research revealed that terminal patients had moderate to severe dignity loss, and approximately 40% of them suffered from dignity-related distress, which required assistance from health professionals. This is a second- and third-year study project. The first-year study established and developed the localized "Terminal Patient Dignity Model" and "Terminal Patient Dignity Scale" for Taiwan. At present, the reliability and validity of the scale are being continuously tested. The second-year study adopts a longitudinal study design. The dignity therapy is referred for intervention. It adopts the randomized controlled experimental study method. Patients with terminal illness in a medical center will be randomly assigned to two groups, and each group is expected to have 34 patients. The experimental group will be provided with dignity therapy, whereas hospice palliative care will be adopted for the control group. Dignity, demoralization, depression, and other indicators will be measured in the pretest, immediately after the intervention, at 1 month and 3 months. In the third year, the study project will continue the intervention scheme and track the results of dignity, demoralization, depression, and other indicators at 6 and 9 months after the intervention. This study can help understand the status of dignity among terminal patients in Taiwan, and extend the terminal patient dignity scale and dignity therapy to noncancer terminal patients, in order to provide appropriate care to maintain dignity. It is also expected to provide a reference for the government to formulate empirical care policies on dignity therapy.

Conditions

End of Life Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

dignity therapy

Dignity therapists use the "Dignity Psychotherapy Question Protocol" to guide patients through life's most important issues, providing them with the opportunity to participate in and discuss the things they would like their families to remember them for. During the process, dignity therapists use audio recording to fully record, transcribe, and edit the interview material, creating a valuable record that the patient wishes to preserve. The edited document is then returned to the patient, who then gives it to their family members.

Group Type: EXPERIMENTAL

dignity therapy

Intervention Type: BEHAVIORAL

Dignity therapists use the "Dignity Psychotherapy Question Protocol" to guide patients through life's most important issues, providing them with the opportunity to participate in and discuss the things they would like their families to remember them for. During the process, dignity therapists use audio recording to fully record, transcribe, and edit the interview material, creating a valuable record that the patient wishes to preserve. The edited document is then returned to the patient, who then gives it to their family members.

Hospice palliative care

Participants routinely performed hospice palliative care

Group Type: PLACEBO_COMPARATOR

Hospice palliative care

Intervention Type: BEHAVIORAL

Participants regularly receive hospice care

Interventions

dignity therapy

Dignity therapists use the "Dignity Psychotherapy Question Protocol" to guide patients through life's most important issues, providing them with the opportunity to participate in and discuss the things they would like their families to remember them for. During the process, dignity therapists use audio recording to fully record, transcribe, and edit the interview material, creating a valuable record that the patient wishes to preserve. The edited document is then returned to the patient, who then gives it to their family members.

Intervention Type: BEHAVIORAL

Hospice palliative care

Participants regularly receive hospice care

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Patients diagnosed with a terminal illness by their attending physician, whose disease has progressed to the point where death is inevitable, and who are receiving palliative care such as hospice care, hospice home care, or hospice co-care.

2. Patients aged 20 or above.

3. Patients who can communicate in Mandarin or Taiwanese.

4. Patients who are willing to participate in this research project and complete the consent form after the purpose and process of the research are explained.

Exclusion Criteria

1. Those diagnosed by a physician with dementia, delirium, or other organic brain disease.

2. Those who are unconscious and incapable of acting.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH), Taiwan

UNKNOWN

Sponsor Role: collaborator

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kaohsiung Medical University

Kaohsiung City, , Taiwan

Countries

Taiwan

Other Identifiers

KMUHIRB-F(I)-20220202

Identifier Type: -

Identifier Source: org_study_id