UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000032718 |
|---|---|
| Receipt number | R000037309 |
| Scientific Title | Comparison of the burden on nurses and wheelchair-enabled patients due to different methods of toileting assistance with and without sit-to-stand lifts |
| Date of disclosure of the study information | 2018/05/26 |
| Last modified on | 2022/08/01 19:05:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comparison of the burden on nurses and wheelchair-enabled patients due to different methods of toileting assistance with and without sit-to-stand lifts
Acronym
Burden on nurses and wheelchair-enabled patients from different toileting assistance methods
Scientific Title
Comparison of the burden on nurses and wheelchair-enabled patients due to different methods of toileting assistance with and without sit-to-stand lifts
Scientific Title:Acronym
Burden on nurses and wheelchair-enabled patients from different toileting assistance methods
Region
| Japan |
Condition
Condition
Healthy individuals
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Electromyography (EMG) and goniometry will be used to evaluate the physical effects on nurses and compare the burden from conventional human-powered toileting assistance and newer assistance with sit-to-stand lifts. Also, a questionnaire survey on physical burden will be conducted with nurses and wheelchair-enabled patients to verify whether sit-to-stand lifts reduce physical burden associated with toileting assistance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle activity of surface EMG
Key secondary outcomes
Goniometry
Questionnaires
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
toileting assistance method with sit-to-stand lift
Interventions/Control_2
toileting assistance method without sit-to-stand lift
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
| 24 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Nurses: Inpatient care experience of 3 years or more, and expertise in toileting assistance
Simulated patients: Healthy individuals 65 years of age or older
Key exclusion criteria
Nurses: Acute low back pain
Simulated patient: individuals with motor disorder
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yoshimi |
| Middle name | |
| Last name | Kobayashi |
Organization
Kanagawa University of Human Services*
*No longer with this institution
Division name
School of Nursing, Faculty of Health & Social Services
Zip code
238-8522
Address
1-10-1 Heiseicho, Yokosuka,Kanagawa
TEL
048-828-2796
kobayashi-ktr@kuhs.ac.jp
Public contact
Name of contact person
| 1st name | Yoshimi |
| Middle name | |
| Last name | Kobayashi |
Organization
Kanagawa University of Human Services
Division name
School of Nursing, Faculty of Health & Social Services
Zip code
2388522
Address
1-10-1 Heiseicho, Yokosuka, Kanagawa
TEL
046-828-2500
Homepage URL
wct.nurse.patient@gmail.com
Sponsor or person
Institute
Kanagawa University of Human Services
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Research Ethics Committee, Kanagawa University of Human Services
Address
1-10-1 Heiseicho, Yokosuka, Kanagawa
Tel
046-828-2530
kenkyuurinri@kuhs.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
神奈川県立保健福祉大学
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 26 | Day |
Related information
URL releasing protocol
https://doi.org/10.18892/jsnas.20.0_47
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.18892/jsnas.20.0_47
Number of participants that the trial has enrolled
13
Results
Eight nurses and one healthy person in her 60s as a patient participated in the study.
When using the powered sit-to-stand lift for toileting care, the nurse's muscle activity was reduced and the goniometer showed a lesser degree of forward bending posture compared the one-person-assisted care. In the questionnaire, nurses were positive about this method.
The results of the questionnaire answered by the patient role also reduced her burden.
Results date posted
| 2022 | Year | 08 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Nurses: The nurses should be nurses with at least 3 years of clinical experience and have experience with wheelchair toilet assistance in a hospital ward. Excluded those with acute back pain.
Patient role: A healthy person over 65 years of age, excluding those with musculoskeletal diseases.
Participant flow
Participants in the experiment were recruited using network sampling. Those who were likely to visit the facility where the experiment was conducted were invited to participate.
The cooperation of 13 people was requested, 8 nurses and 1 person playing the role of a patient.
Adverse events
Nothing in particular.
Outcome measures
Muscle activity of surface EMG
Goniometry
Questionnaires
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 29 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2019 | 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
| 2018 | Year | 05 | Month | 25 | Day |
Last modified on
| 2022 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037309
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
