UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research into the objective and subjective effects of reflexology on healthy females -evaluation from core body temperature and skin temperature, subjective indicators-
Title of the study (Brief title)	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	Yoko Tokiwa
Organization	Graduate school of Health Sciences,Gunma University
Division name	Applied health sciences unit
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	Yumi Arai
Organization	Graduate school of Health Sciences,Gunma University
Division name	Applied health sciences unit
Address	3-39-22 Showa-machi,Maebashi City,Gunma, Japan
TEL	027-220-8914
Homepage URL
Email	m15711020@gunma-u.ac.jp

Sponsor
Institute	Gunma University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025243