UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020116 |
|---|---|
| Receipt number | R000023236 |
| Scientific Title | The quantitative analysis of back massage skills in healthy volunteer |
| Date of disclosure of the study information | 2015/12/08 |
| Last modified on | 2024/03/05 12:58:23 |
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Basic information
Public title
The quantitative analysis of back massage skills in healthy volunteer
Acronym
The quantitative analysis of nursing arts
Scientific Title
The quantitative analysis of back massage skills in healthy volunteer
Scientific Title:Acronym
The quantitative analysis of nursing arts
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aims of this study are to clarify expert nurses' back massage skills and psychological change.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Two main outcomes for nurses.
1. Back massage skills parameters: the force, speed, motion and area of back massage on hand, voice volume and pitch, time and position.
2. Psychological parameters: Two dimensional Mood Scale-Short Term (TDMS), heart rate variability and questionnaire.
Key secondary outcomes
Sub outcomes for a healthy volunteer: heart rate variability and questionnaire.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
20 nurses provide back massage for a healthy volunteer. Each nurse provides it twice and the test term leaves to their option.
In the test, expert nurses are measured back massage skills and psychological change before and after the test.
The healthy volunteer is measured heart rate variability evaluates intervention effect and fills out the questionnaire.
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
For expert nurses:
1. work over 5 years of experience and still working for nurse
2. be evaluated by patient or someone in back massage skill
For a healthy volunteer:
1. BMI: 18.5~25.0
Key exclusion criteria
For expert nurses:
1. be in therapy or have a history of cardiac disease, hypertension, skin disease and autonomic insufficiency.
2. be affected with locomotor apparatus disease.
For a healthy volunteer:
1. be in therapy or have a history of cardiac disease, hypertension, skin disease and autonomic insufficiency.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masayo |
| Middle name | |
| Last name | Kashiwagi |
Organization
Tokyo Medical and Dental university, Graduate School of Health Care Sciences
Division name
Division of Fundamental and scientific Nursing care innovation
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5345
kashiwagi.fnls@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Masayo |
| Middle name | |
| Last name | Kashiwagi |
Organization
Tokyo Medical and Dental university, Graduate School of Health Care Sciences
Division name
Division of Fundamental and scientific Nursing care innovation
Zip code
1138519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5345
Homepage URL
kashiwagi.fnls@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental university, Graduate School of Health Care Sciences
Institute
Department
Personal name
Funding Source
Organization
None
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
Tokyo Medical and Dental university Medical ERB
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
03-3813-6111
info.bec@tmd.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
東京医科歯科大学
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 08 | 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
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 08 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 08 | Day |
Last modified on
| 2024 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023236
| Research Plan | |
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| Registered date | File name |
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