UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022366 |
|---|---|
| Receipt number | R000025243 |
| Scientific Title | Research into the objective and subjective effects of reflexology on healthy females -evaluation from core body temperature and skin temperature, subjective indicators- |
| Date of disclosure of the study information | 2016/05/23 |
| Last modified on | 2017/10/16 21:41:22 |
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Basic information
Public title
Research into the objective and subjective effects of reflexology on healthy females
-evaluation from core body temperature and skin temperature, subjective indicators-
Acronym
Research into effects of reflexology
Scientific Title
Research into the objective and subjective effects of reflexology on healthy females
-evaluation from core body temperature and skin temperature, subjective indicators-
Scientific Title:Acronym
Research into effects of reflexology
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the objective and subjective effects of reflexology on healthy females
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Core temperature before and after intervention
1.before intervention
2.20 minutes after starting intervention
3.right after intervention
4.5 minutes after
5.10 minutes after
6.15 minutes after
Key secondary outcomes
Skin temperature,pulse,blood pressure,ancle and foot circumference measurement,conscious symptoms(before and 15 minutes after intervention)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
45minutes reflexology treatment(one time for a person)
Order of the interventions is randomized by lot.Two interventions are carried out on different days of follicular phase in same menstrual cycle.
Interventions/Control_2
45minutes rest(one time for a person)
Order of the interventions is randomized by lot.Two interventions are carried out on different days of follicular phase in same menstrual cycle.
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
| 39 | years-old | >= |
Gender
Female
Key inclusion criteria
1)Female nurses who work at Gunma University Hospital
2)Persons who meet the conditions following 1-4
1.Persons who have no cardiovascular disease and blood disease
2.Persons who have no injury and infectious disease, pain of foot
3.Persons who are not pregnant
4.Persons with a stable menstrual cycle
Key exclusion criteria
Persons who do not satisfy the above criteria
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoko Tokiwa |
Organization
Graduate school of Health Sciences,Gunma University
Division name
Applied health sciences unit
Zip code
Address
3-39-22 Showa-machi,Maebashi City,Gunma, Japan
TEL
027-220-8914
ytokiwa@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yumi Arai |
Organization
Graduate school of Health Sciences,Gunma University
Division name
Applied health sciences unit
Zip code
Address
3-39-22 Showa-machi,Maebashi City,Gunma, Japan
TEL
027-220-8914
Homepage URL
m15711020@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma 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
Address
Tel
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
| 2016 | Year | 05 | Month | 23 | 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
| 2016 | Year | 04 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 19 | Day |
Last modified on
| 2017 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025243
