Tokyo, Oct. 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063192) titled 'Effects of a Death Cafe Intervention Among Nurses: A Randomized Controlled Trial With Post-intervention Interviews' on Oct. 6.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - National Defense Medical College
Condition:
Condition - Nurses (not a disease-specific study)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The primary objective of this study is to evaluate the effects of a Death Cafe intervention on terminal care attitudes among nurses working at a single acute care hospital in Japan through a randomized controlled trial. Secondary exploratory objectives are to examine changes in each subscale score of the Death Attitude Inventory (DAI) and associations between these changes and changes in terminal care attitudes. In addition, post-intervention focus group interviews and free-text questionnaire responses will be used to explore participants' experiences of dialogue and insights, providing a complementary understanding of the context and meaning of the quantitative findings.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Intervention group (Group A):
Each participant will attend one approximately 60-minute Death Cafe session involving participant-led dialogue about death and life. Each group will normally comprise five participants, with adjustments to four to six participants as needed. The session will consist of a five-minute introduction and explanation of ground rules, 50 minutes of dialogue, and a five-minute closing. The same facilitator will conduct all sessions using a predefined discussion theme and a facilitation checklist.
One approximately 60-minute focus group interview will be conducted for evaluation purposes on the same day after the Death Cafe. Both the Death Cafe and the interview will be audio-recorded.
Questionnaires will be administered one week before, one week after, and one month after the Death Cafe.
Interventions/Control_2 - Control group (Group B):
Participants will continue their usual work and daily activities without receiving a study-provided Death Cafe session or focus group interview during the comparative assessment period.
The same questionnaires as those used in the intervention group will be administered at three time points: one week before, one week after, and one month after a prespecified corresponding Death Cafe date.
After the study period ends, participants who wish to attend will be offered an opportunity to participate in a Death Cafe.
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Nurses employed at the participating acute care hospital in Japan.
2. Previous experience of participating in a death conference.
3. Ability to understand the purpose and procedures of the study and provision of voluntary written informed consent.
Key exclusion criteria - 1. Individuals judged by the investigator to be at risk of substantial psychological distress from participation in research concerning terminal care. Eligibility will be determined in consultation with the individual, using an individual consultation and the K6 psychological distress scale as needed.
2. Individuals planning to take a leave of absence or leave their employment during the data collection period.
Target Size - 50
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2027 Year 05 Month 26 Day
Date of IRB - 2027 Year 06 Month 16 Day
Anticipated trial start date - 2027 Year 10 Month 07 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072317
Disclaimer: Curated by HT Syndication.