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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name