UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037651 |
|---|---|
| Receipt number | R000042934 |
| 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 |
| Date of disclosure of the study information | 2019/08/10 |
| Last modified on | 2021/12/03 18:24:07 |
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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
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
eritano@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042934
| Research Plan | |
|---|---|
| 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 |
