UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039113 |
|---|---|
| Receipt number | 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 | 2021/07/09 19:04:38 |
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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
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
kawai@kkh.biglobe.ne.jp
Sponsor or person
Institute
Fujita Health University Hospital
Institute
Department
Personal name
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
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
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000044609
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.3918/jsicm.28_277
Number of participants that the trial has enrolled
16
Results
Some patients reported that physical restraint did not pose a safety problem. However, some believed that it should not be used because it violated the human rights and dignity of patients (the certainty of the evidence was low). The medical staff was worried about the adverse events, but reported that they
used it for safety (high). The medical staff believed that, as alternatives to physical restraint, it was important to modify the existing system (high).
Results date posted
| 2021 | Year | 07 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Our search identified 16 studies for inclusion.
Participant flow
systematic review
Adverse events
Not applicable
Outcome measures
The views of patients or their families and medical staff regarding physical restraint and its alternatives in the ICU.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2021 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044609
| Research Plan | |
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| 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 |
