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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039113
Receipt No. R000044609
Scientific Title Physical restraint in the intensive care unit: a qualitative systematic review
Date of disclosure of the study information 2020/01/10
Last modified on 2020/07/12

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Basic information
Public title Physical restraint in the intensive care unit: a qualitative systematic review
Acronym A qualitative systematic review of physical restraint
Scientific Title Physical restraint in the intensive care unit: a qualitative systematic review
Scientific Title:Acronym A qualitative systematic review of physical restraint
Region
Japan

Condition
Condition critically ill patients requiring intensive care
Classification by specialty
Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To identify patients' and their families' thoughts regarding physical restraint, medical staff's thoughts regarding physical restraint, alternatives to physical restraint.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Patients' and their families' thoughts regarding physical restraint, medical staff's thoughts regarding physical restraint, alternatives to physical restraint.
Key secondary outcomes

Base
Study type Others,meta-analysis etc

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Studies on ICU patients who are 18 years old or over and their family, or ICU staff.
qualitative studies (interviews, field research, focus group, open-ended questionnaire).
Key exclusion criteria Quantitative research
Case reports or case series
non-English and non-Japanese language abstracts
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Osamu
Middle name
Last name Nishida
Organization Fujita Health University School of Medicine
Division name Department of Anesthesiology and Critical Care Medicine
Zip code 470-1192
Address 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL 0562-93-9008
Email nishida@fujita-hu.ac.jp

Public contact
Name of contact person
1st name Yusuke
Middle name
Last name Kawai
Organization Fujita Health University Hospital
Division name Department of Nursing
Zip code 470-1192
Address 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL 0562-93-2111
Homepage URL
Email kawai@kkh.biglobe.ne.jp

Sponsor
Institute Fujita Health University Hospital
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 Fujita Health University Hospital
Address 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan.
Tel 0562-93-2111
Email kawai@kkh.biglobe.ne.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
2020 Year 01 Month 10 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 297
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
2019 Year 04 Month 10 Day
Date of IRB
2019 Year 04 Month 10 Day
Anticipated trial start date
2019 Year 04 Month 25 Day
Last follow-up date
2020 Year 01 Month 31 Day
Date of closure to data entry
2020 Year 02 Month 22 Day
Date trial data considered complete
2020 Year 03 Month 05 Day
Date analysis concluded
2020 Year 03 Month 10 Day

Other
Other related information We searched the MEDLINE, CENTRAL, CINAHL, JAPAN MEDICAL ABSTRACTS SOCIETY.
Two reviewers (Yusuke Kawai, Toru Yamada) independently screened the title and abstract of each study returned by the search to determine whether the inclusion criteria were met. Disagreement was resolved by discussion between the two reviewers, occasionally with arbitration by a third reviewer (Kazuma Yamakawa).
We used GRADE-CERQual(Confidence in the Evidence from Reviews of Qualitative research) to assess confidence in review findings.

Management information
Registered date
2020 Year 01 Month 10 Day
Last modified on
2020 Year 07 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044609

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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