UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063154 |
|---|---|
| Receipt number | R000072281 |
| Scientific Title | Development of a mental health training program focused on self-care for DMAT nurses |
| Date of disclosure of the study information | 2026/10/02 |
| Last modified on | 2026/10/02 17:12:14 |
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Basic information
Public title
Development of a training program on disaster stress management for nurses in Disaster Medical Assistance Team
Acronym
Development of a stress management training program for nurses in Disaster Medical Assistance Team
Scientific Title
Development of a mental health training program focused on self-care for DMAT nurses
Scientific Title:Acronym
Development of a Mental Health Training Program for DMAT Nurses
Region
| Japan |
Condition
Condition
DMAT nurse team members with disaster response experience
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We believe that conducting mental health training centered on self-care is an effective way to ensure that DMAT nurses can perform their duties adequately at their assignment sites. To achieve this, we believe it is necessary to review the content of the training program, evaluate it, and conduct pilot tests.
The objective of this study is, first, to clarify the current state of mental health among DMAT nurses after deployment and the factors associated with it; and, based on these findings, to develop a training program centered on self-care to help nurse volunteers cope with disaster-related stress.
Basic objectives2
Others
Basic objectives -Others
To clarify the current state of mental health among DMAT nurses following their deployment and the factors associated with it, and, based on these findings, to develop a training program centered on self-care to help nurse team members cope with disaster-related stress.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) A Longitudinal analysis of mental health and associated factors following the deployment of DMAT members
An online questionnaire survey was conducted over a period of approximately two months.
IES-R scores, K6 scores, and self-care scale scores, along with the factors associated with them
(2) Development of a training program centered on self-care to address disaster stress among DMAT nurses
Conducted an interview survey with DMAT nurses
Individual responses to and coping strategies for disaster stress; current self-care practices and challenges; and requests regarding the specific content and implementation methods of the training program
Key secondary outcomes
(1) A Longitudinal analysis of mental health and associated factors following the deployment of DMAT members
An online questionnaire survey was conducted over a period of approximately two months.
Specific self-care methods used by DMAT members and differences by profession
(2) Development of a training program centered on self-care to address disaster stress among DMAT nurses
Conducted an interview survey with DMAT nurses
The impact of communication among nurses
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) A longitudinal study on the mental health of DMAT members following deployment and related factors
DMAT team members working at designated DMAT medical institutions and hospitals in Japan
DMAT team members who have actually participated in disaster response activities prior to the survey
Any gender
20 years of age or older
Individuals who are in good health and capable of performing their normal duties
Individuals who checked the consent box on the online survey form and agreed to participate in this study
(2) Development of a training program centered on self-care to address stress among DMAT nurses
DMAT nurses employed at DMAT-designated hospitals in Japan
DMAT nurses who have actually participated in disaster response activities prior to the interview survey
Any gender
20 years of age or older
Individuals in good health who are able to perform their regular duties
Individuals who have given their consent to participate in this study by checking the consent box on the webpage and entering their name to confirm their intention to participate in the interview survey
Key exclusion criteria
People who have received psychiatric treatment within the past 6 months
People who reported having mental health issues at the time of the survey
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Satoh |
Organization
Hamamatsu University School of Medicine
Division name
Clinical Nursing
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu, Shizuoka 431-3192, Japan
TEL
053-435-2808
yu-ki@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Satoh |
Organization
Hamamatsu University School of Medicine
Division name
Clinical Nursing
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu, Shizuoka 431-3192, Japan
TEL
053-435-2808
Homepage URL
yu-ki@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Yuki Satoh
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
University of Tsukuba
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu, Shizuoka 431-3192, Japan
Tel
053-435-2808
yu-ki@hama-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
372
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2025 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 14 | Day |
Date of closure to data entry
| 2026 | Year | 09 | Month | 09 | Day |
Date trial data considered complete
| 2026 | Year | 10 | Month | 11 | Day |
Date analysis concluded
| 2026 | Year | 12 | Month | 31 | Day |
Other
Other related information
For this study, we sent a research protocol, a survey request form, a sample web survey form, and a reply postcard for requesting additional survey request forms to the heads of DMAT-designated medical institutions nationwide and to the directors of nursing at each facility. We then obtained permission to distribute a sheet of paper bearing the QR code for this study's website to eligible team members at those facilities. Participants were asked to respond anonymously, and it was explained in writing that checking the consent box on the web questionnaire would be considered as consent to participate in the study. Furthermore, participants were asked to check a box indicating their willingness to participate in interviews and to provide their contact information for future contact; it was explained in writing that doing so would be considered as consent to participate in the interviews.
The web survey was conducted as a cross-sectional study targeting 361 nurse, physician, and logistics team members working at DMAT-designated medical institutions nationwide who had experience being deployed as part of a DMAT team. Psychological distress was assessed using the K6, and post-traumatic stress symptoms were assessed using the IES-R. We conducted a hierarchical multiple regression analysis using the following explanatory variables: gender, job type, post-deployment stress, major stressful experiences within the past 10 years, support environment, and presence or absence of self-care.
For the interview study, we contacted participants who had checked the consent box during the web survey at a later date and conducted focus group interviews (FGIs) with 11 DMAT nurses who had experience being deployed as part of DMAT.
Management information
Registered date
| 2026 | Year | 10 | Month | 02 | Day |
Last modified on
| 2026 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072281
