UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054175 |
|---|---|
| Receipt number | R000061864 |
| Scientific Title | Assessment of Ease in Positioning -Relation between subjective evaluation and objective evaluation using autonomic index- |
| Date of disclosure of the study information | 2024/04/19 |
| Last modified on | 2024/04/17 12:09:13 |
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Basic information
Public title
Assessment of Ease in Positioning -Relation between subjective evaluation and objective evaluation using autonomic index-
Acronym
Assessment of Ease in Positioning -Relation between subjective evaluation and objective evaluation using autonomic index-
Scientific Title
Assessment of Ease in Positioning -Relation between subjective evaluation and objective evaluation using autonomic index-
Scientific Title:Acronym
Assessment of Ease in Positioning -Relation between subjective evaluation and objective evaluation using autonomic index-
Region
| Japan |
Condition
Condition
Healthy individuals
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the possibility of using autonomic nervous activity as a measure of comfort in positioning.
To clarify the relationship between subjective indices over time in basic positions such as supine, lateral recumbent, and prone, and objective indices of autonomic nervous system activity obtained from heart rate data.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective evaluation of ease using VAS
Heart rate variability data
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Adjustment of body position
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
| 39 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adult men and women aged 18-39 years
Key exclusion criteria
Those who are aware of sensory neuropathy, motor neuropathy, etc. and have difficulty in daily activities, and those who do not agree to the lifestyle requirements related to the survey.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Takahashi |
Organization
Graduate School of Nursing Sapporo City University
Division name
Graduate School of Nursing
Zip code
0600011
Address
Kita 11 Nishi 13, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
0117262500
2172004@st.scu.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Takahashi |
Organization
Graduate School of Nursing Sapporo City University
Division name
Graduate School of Nursing
Zip code
0600011
Address
Kita 11 Nishi 13, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
0117262500
Homepage URL
2172004@st.scu.ac.jp
Sponsor or person
Institute
Sapporo City University
Institute
Department
Personal name
Funding Source
Organization
Sapporo City University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Nursing Sapporo City University
Address
Kita 11 Nishi 13, Chuo-ku, Sapporo, Hokkaido, Japan
Tel
0117262500
2172004@st.scu.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
| 2024 | Year | 04 | Month | 19 | 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
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
Preinitiation
Date of protocol fixation
| 2024 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 17 | Day |
Last modified on
| 2024 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061864
| 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 |
