UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028507 |
|---|---|
| Receipt number | R000032625 |
| Scientific Title | Randomized clinical trial on a CBT-based communication skills training for perinatal loss care providers in Japan |
| Date of disclosure of the study information | 2017/08/03 |
| Last modified on | 2021/02/28 12:09:10 |
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Basic information
Public title
Randomized clinical trial on a CBT-based communication skills training for perinatal loss care providers in Japan
Acronym
A CBT-based communication training for perinatal loss care providers
Scientific Title
Randomized clinical trial on a CBT-based communication skills training for perinatal loss care providers in Japan
Scientific Title:Acronym
A CBT-based communication training for perinatal loss care providers
Region
| Japan |
Condition
Condition
Nurses and midwives who report high stress and sense of difficulty related to communicating with patients and families who lost their babies during the perinatal period.
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This RCT aims to examine the efficacy of a training program by measuring clinicians' self-efficacy in their communication skills.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinicians' self-efficacy in communicating with patients
(pre- and 3-month-post-intervention)
Key secondary outcomes
Anxiety and sense of difficulty in communication
Knowledge about effective communication
Belief in communication
Communication behaviors
Self-compassion
Compassion fatigue
(pre- and 3-month-post-intervention)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Duration will be 6 weeks. Intervention will be given twice (beginning and 6 weeks later). Midwives, a psychologist, and a counselor who has experienced perinatal loss will provide an initial 2-day communication skills training (6 hours per day) as well as the second daylong intervention (5 hours).
Interventions/Control_2
Will receive training upon completion of the experiment.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Licensed midwives and nurses who meet the following criteria:
Having provided direct care for patients and families who experienced death of a child during the perinatal period.
Having an opportunity to provide direct care for patients and families who had perinatal death.
Key exclusion criteria
Individuals who lack fluency in spoken and written Japanese and those who have plans to leave clinical practice during the study.
Target sample size
84
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akiko Hiruta |
Organization
St. Luke's International University
Division name
Division of Women's Health and Midwifery
Zip code
Address
10-1, Akashi-cho, Chuo-ku, Tokyo, Japan
TEL
+81-3-3543-6391
akiko-hiruta@slcn.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiko Hiruta |
Organization
St. Luke's International University
Division name
Division of Women's Health and Midwifery
Zip code
Address
10-1, Akashi-cho, Chuo-ku, Tokyo, Japan
TEL
+81-3-3543-6391
Homepage URL
akiko-hiruta@slcn.ac.jp
Sponsor or person
Institute
St. Luke's International University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology - Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
聖路加国際大学
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 03 | 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
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
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 15 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 02 | Day |
Last modified on
| 2021 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032625
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
