UMIN-CTR Clinical Trial

Basic information
Public title	A study for establishing what nursing skills are required in repositioning a patient up in bed with a focus on the patient's comfort
Acronym	A study for establishing what nursing skills are required in repositioning a patient up in bed with a focus on the patient's comfort
Scientific Title	A study for establishing what nursing skills are required in repositioning a patient up in bed with a focus on the patient's comfort
Scientific Title:Acronym	A study for establishing what nursing skills are required in repositioning a patient up in bed with a focus on the patient's comfort
Region	Japan

Condition
Condition	Healthy elderly adults
Classification by specialty	Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess how assisted repositioning up in bed affects the patient's comfort and identify the influential factors, with an ultimate aim of establishing what nursing skills are required to offer a better comfort to patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Autonomic nervous activities
Key secondary outcomes	Body angles Subjective assessment Time required for repositioning a patient up in bed

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Without using sliding sheets as assistive devices
Interventions/Control_2	Sliding sheets inserted from the patient's head side and the patient moved with a transfer belt
Interventions/Control_3	Sliding sheets inserted from the front side of the side-lying patient and the patient moved from the lateral side of the bed
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Healthy elderly persons aged 65 years or older
Key exclusion criteria	Those with a present history of neuropathy, diabetes mellitus, severe heart disease, arrhythmia, or uncontrolled hypertension Those who suffer from pain when being repositioned with assistance Those having cognitive difficulties Those with a Body Mass Index (BMI)of<18.5 or >=25
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Erika Middle name Last name Shudo
Organization	Sapporo Medical University
Division name	Department of Nursing, School of Health Sciences
Zip code	060-8556
Address	S1,W17,Chuoku,Sapporo
TEL	011-611-2111
Email	eritano@sapmed.ac.jp

Public contact
Name of contact person	1st name Erika Middle name Last name Shudo
Organization	Sapporo Medical University
Division name	Department of Nursing, School of Health Sciences
Zip code	060-8556
Address	S1,W17,Chuoku,Sapporo
TEL	011-611-2111
Homepage URL
Email	eritano@sapmed.ac.jp

Sponsor
Institute	Sapporo Medical University
Institute
Department

Funding Source
Organization	Grant-in-Aid for Scientific Research
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	Sapporo Medical University Research Ethics Committee
Address	S1, W17, Chuo-ku, Sapporo
Tel	011-611-2111
Email	rinri@sapmed.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

Other administrative information
Date of disclosure of the study information	2019 Year 08 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	10
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	Completed
Date of protocol fixation	2019 Year 07 Month 01 Day
Date of IRB	2019 Year 07 Month 01 Day
Anticipated trial start date	2019 Year 08 Month 15 Day
Last follow-up date	2022 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	2019 Year 08 Month 09 Day
Last modified on	2021 Year 12 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042934