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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000004186
Receipt No. R000005020
Scientific Title RCT of Tactile touch for elderly people
Date of disclosure of the study information 2010/09/10
Last modified on 2011/12/01

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Basic information
Public title RCT of Tactile touch for elderly people
Acronym RCT of Tactile touch for elderly people
Scientific Title RCT of Tactile touch for elderly people
Scientific Title:Acronym RCT of Tactile touch for elderly people
Region
Japan

Condition
Condition healthy elderly people
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to find the efficacy of tactile touch for healthy eldery people.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II,III

Assessment
Primary outcomes HR, HRV(HF, LH/HF), Blood Pressure, Skin Temperature, Blood flow, finger pulse wave, VAS(relax-tension) and POMS
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 rest(base line)(5min), Blood Pressure Measurement(2min), tactile touch for left hand (10min), rest(5min)
Interventions/Control_2 rest(base line)(5min), Blood Pressure Measurement(2min), rest(15min)
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
65 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria The erderly people who has an ablily of decision making by oneself about the participation to the research, and who sends a normal social life and has a physical strength for going out alone.
Key exclusion criteria plan to move/renovate, the damage of a blood vessel and the lymph of arms.
Target sample size 44

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukari Kawahara
Organization The Japanese Red Cross College of Nursing
Division name Department of Fundamental nursing
Zip code
Address 4-1-3, Hiroo, Shibuya, Tokyo, Japan, 150-0012
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization The Japanese Red Cross College of Nursing
Division name Department of Fundamental Nursing
Zip code
Address 4-1-3, Hiroo, Shibuya, Tokyo, Japan, 150-0012
TEL
Homepage URL
Email

Sponsor
Institute The Japanese Red Cross College of Nursing
Institute
Department

Funding Source
Organization Scientific Research from the Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
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 日本赤十字看護大学

Other administrative information
Date of disclosure of the study information
2010 Year 09 Month 10 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 No longer recruiting
Date of protocol fixation
2010 Year 07 Month 20 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
2011 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 09 Month 10 Day
Last modified on
2011 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005020

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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