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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028507
Receipt No. 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 2018/08/06

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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
Email 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
Email akiko-hiruta@slcn.ac.jp

Sponsor
Institute St. Luke's International University
Institute
Department

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
Email

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 Open public recruiting
Date of protocol fixation
2017 Year 06 Month 01 Day
Date of IRB
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
2018 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032625

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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