UMIN-CTR Clinical Trial

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