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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021894
Receipt No. R000022960
Scientific Title Situated learning for nurses to progress the communication of lightly sedated conscious patients on mechanical ventilators in an ICU.
Date of disclosure of the study information 2016/04/13
Last modified on 2019/04/17

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Basic information
Public title Situated learning for nurses to progress the communication of lightly sedated conscious patients on mechanical ventilators in an ICU.
Acronym Situated learning for nurses to progress the communication of lightly sedated conscious patients on mechanical ventilators in an ICU.
Scientific Title Situated learning for nurses to progress the communication of lightly sedated conscious patients on mechanical ventilators in an ICU.
Scientific Title:Acronym Situated learning for nurses to progress the communication of lightly sedated conscious patients on mechanical ventilators in an ICU.
Region
Japan

Condition
Condition ICU nurse
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To create the model of care for situated learning for nurses to progress the communication of lightly sedated conscious patients on mechanical ventilators in an ICU.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Qualitative change of recognition and the practice of the nurse before and after the intervention.
Key secondary outcomes Change of the subjective evaluation of the patient on the change of the nurse's recognition and the practice.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 to make the nurse observing the intentionalness of the patient during daily life care duties and compare the change in the communication with the patient.
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 ICU nurse


Key exclusion criteria None


Target sample size 20

Research contact person
Last name of lead principal investigator
1st name Ayako
Middle name
Last name Noguchi
Organization Tokyo Medical and Dental University Graduate School of Health Care Siences.
Division name Critical and Invasive-palliative Care Nursing
Zip code 113-8510
Address 1-5-45 Yushima Bunkyoku Tokyo
TEL 03-3813-6111(7768)
Email ayakcc@tmd.ac.jp

Public contact
1st name of contact person
1st name Ayako
Middle name
Last name Noguchi
Organization Tokyo Medical and Dental University Graduate School of Health Care Siences.
Division name Critical and Invasive-palliative Care Nursing
Zip code 113-8510
Address 1-5-45 Yushima Bunkyoku Tokyo
TEL 03-3813-6111(7768)
Homepage URL
Email ayakcc@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Faculty of Medicine of Tokyo Medical and DentalUniversity Ethics Committee
Address 1-5-45 Yushima Bunkyoku Tokyo
Tel 03-5803-4085
Email info.bec@tmd.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 京都府立医科大学附属病院 University Hospital, Kyoto Prefectural University of Medicine

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 13 Day

Related information
URL releasing protocol org/10.1016/j.iccn.2018.10.006
Publication of results Published

Result
URL related to results and publications org/10.1016/j.iccn.2018.10.006
Number of participants that the trial has enrolled 57
Results
After the intervention, the incidence-rate ratios for nurses noticing of patients' intent to communicate were 1.53; there was no change in the frequency of patients' intent to communicate. Further, nurses became more aware of and reflected on their own practices, showed increased interest in co-workers' practices, and considered their actions from patients' perspectives. Patients' satisfaction with nurses' respect for their wishes and dignity also increased.
Results date posted
2019 Year 04 Month 17 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The intensive care unit of a university hospital.
Participant flow
Action research was applied. Specifically, three interventions promoting awareness of patients' intent to communicate were administered and, pre- and post-intervention, observations of patient-nurse interactions, unstructured interviews with nurses, and a patients' satisfaction survey were conducted. 
Adverse events
none
Outcome measures
Nurses' awareness of lightly sedated mechanically ventilated patients' intent to communicate
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 04 Month 01 Day
Date of IRB
2016 Year 01 Month 26 Day
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 04 Month 13 Day
Last modified on
2019 Year 04 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022960

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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