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IRCT20240725062542N1 IRCT 2024-11-28 Qazvin University of Medical Sciences The Effect of Dignity Therapy on the Demoralization in Patients Undergoing Chemotherapy in Qazvin City, 2024 The Effect of Dignity Therapy on the Demoralization in Patients Undergoing Chemotherapy 2024-12-31 anticipated 84 Complete https://irct.ir/trial/79752 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Randomization description: 1. Participants will be selected based on inclusion criteria and availability through a convenience sampling method. 2. After selection, they will be assigned to either group using a simple randomization with balanced blocks. 3. Given the study's two-group nature, a balanced block randomization with a block size of 4 will be employed for the randomization. 4. To determine the randomization order by a block of 4, an online tool for producing random allocation lists (https://www.sealedenvelope.com/simple-randomiser/v1/lists) will be used. N/A Cancer, Chemotherapy. Intervention 1: Intervention Group: Dignity therapy is a brief individual therapy in which the therapist asks a series of open-ended questions to the patient within a 30 to 60-minute session, encouraging them to talk about their life and significant events. The patient's speech is recorded, rewritten, and edited. After a few days, it is returned to the patient to allow the creation of necessary changes before the final version is prepared. The final version is kept as a booklet as a memento for the patient's family and loved ones. Intervention 2: Control Group: In the control group, questionnaires are completed initially, immediately after the intervention, and 3 months post-intervention. At the end, a booklet containing educational points on the disease and points that should be observed during the disease is given to the patient. https://www.sciencedirect.com/science/article/abs/pii/S1462388925001589 Abstract Purpose Demoralization is a common psychological distress experienced by cancer patients undergoing chemotherapy. This study aimed to evaluate the effectiveness of nurse-led dignity therapy in reducing demoralization syndrome among this patient population. Methods A randomized controlled trial was conducted with 84 patients undergoing chemotherapy, who were allocated to either an intervention group (n = 42) receiving three sessions of dignity therapy by a trained oncology nurse, or a control group (n = 42) receiving standard care. Assessments were performed at baseline, one month, and three months post-intervention using a demographic questionnaire and the Demoralization Scale (DS). Data were analyzed using repeated-measures multivariate analysis of variance (MANOVA-RM) to examine changes in demoralization over time and between groups. Results The intervention group showed a significant reduction in demoralization symptoms compared to controls (P < 0.001, standardized mean difference = –1.65). The group-by-time interaction was significant (P = 0.006), indicating that the effects were maintained at follow-up. Conclusions Nurse-led dignity therapy is an effective psychotherapeutic intervention to alleviate demoralization syndrome in patients undergoing chemotherapy. Its integration into oncology nursing practice may enhance psychological outcomes and overall patient care. Keywords: Cancer, Chemotherapy, Dignity Therapy, Demoralization, Nurse-led Intervention Yes - There is a plan to make this available What will be shared: All data collected will potentially be shareable after the participants have been de-identified. When: The data will be available 6 months after the study results have been published. To whom: The data will only be accessible to researchers affiliated with academic and research institutions. Conditions: The results of this study may be used by researchers for future studies, provided that they obtain permission from the project coordinators. Where to obtain: Executors of the plan: Sima Kazemi (nurse.simakazemi@gmail.com) Mohammad Ali Soleimani (soleimany.msn@gmail.com) How to obtain: Please contact us via email for further communication. Comments:
public Sima Kazemi
Faculty of Nursing and Midwifery, Qazvin University of Medical Sciences, Bahonar Blvd, Qazvin, Iran
Qazvin Iran (Islamic Republic of) 59811-34197 +98 28 3333 6001 nurse.simakazemi@gmail.com Qazvin University of Medical Sciences scientific Mohammad Ali Soleimani
Faculty of Nursing and Midwifery, Qazvin University of Medical Sciences, Bahonar Blvd, Qazvin, Iran
Qazvin Iran (Islamic Republic of) 59811-34197 +98 28 3333 6001 soleimany.msn@gmail.com Qazvin University of Medical Sciences Iran (Islamic Republic of) 1. Willingness to participate in the research and complete the consent form 2. Full consciousness and the ability to communicate 3. People over 18 years old 4. Being literate in reading and writing in the Persian language 5. Starting chemotherapy at least 6 months ago 6. Access to a phone or mobile for follow-up 18 years no limit Both 1. Diagnosis of a psychiatric disorder and use of psychotropic drugs (as diagnosed by a physician) 2. Experience of spiritual crises in the last 6 months (self-report) 3. Use of alcohol and drugs (self-report) Z51.2 Maintenance chemotherapy NOS Behavior Behavior Intervention Group: Dignity therapy is a brief individual therapy in which the therapist asks a series of open-ended questions to the patient within a 30 to 60-minute session, encouraging them to talk about their life and significant events. The patient's speech is recorded, rewritten, and edited. After a few days, it is returned to the patient to allow the creation of necessary changes before the final version is prepared. The final version is kept as a booklet as a memento for the patient's family and loved ones. Control Group: In the control group, questionnaires are completed initially, immediately after the intervention, and 3 months post-intervention. At the end, a booklet containing educational points on the disease and points that should be observed during the disease is given to the patient. This is a score that each participant will receive based on the 24-item Distress Thermometer scale developed by Kissane (2004). Timepoint: The Demoralization Syndrome questionnaire will be administered at three different time points: before the intervention, immediately after the intervention, and three months post-intervention for follow-up. Method of measurement: The Demoralization Syndrome (DS) is a tool designed by Kissane and colleagues (2004) to assess Demoralization Syndrome in cancer patients. Qazvin University of Medical Sciences Approved 2024-10-22 Ethics Committee of Qazvin University of Medical Sciences Faculty of Nursing and Midwifery, Qazvin University of Medical Sciences, Bahonar Blvd, Qazvin, Iran Qazvin Qazvin Iran (Islamic Republic of)