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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033131
Receipt No. R000037783
Scientific Title Subjective evaluation by the hand bath of cancer patients with pain
Date of disclosure of the study information 2018/10/01
Last modified on 2019/06/26

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Basic information
Public title Subjective evaluation by the hand bath of cancer patients with pain
Acronym Subjective evaluation by the hand bath of cancer patients with pain
Scientific Title Subjective evaluation by the hand bath of cancer patients with pain
Scientific Title:Acronym Subjective evaluation by the hand bath of cancer patients with pain
Region
Japan

Condition
Condition cancer patient with pain
Classification by specialty
Nursing
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study intervenes in a hand bath for cancer patients with pain and is to determine a subjective evaluation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes pain(Before and after enforcement of hand bath day and the control day)
Key secondary outcomes Interview(after enforcement of hand bath day and the control day)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 hand wash(one day)
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
80 years-old >=
Gender Male and Female
Key inclusion criteria (1) Receive the diagnosis of cancer,
(2) Receive cancer notification,
(3) There is cancer pain,
(4) Is without the mental disorder,
(5) A symptom is stable,
(6) Cannot wash a hand alone,
(7) There is the intention that study entry is possible,
(8) 20 years old or older
Key exclusion criteria The person who does not meet criteria for selection
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Yuka
Middle name
Last name kondo
Organization Gunma University
Division name Graduate school health sciences department of nursing
Zip code 371-8511
Address Showa-machi, maebashi Gunma
TEL 027-220-7771
Email yukondo@gunma-u.ac.jp

Public contact
Name of contact person
1st name Yuka
Middle name
Last name kondo
Organization Gunma University
Division name Graduate school health sciences department of nursing
Zip code 371-8511
Address Showa-machi, maebashi Gunma
TEL 027-220-7771
Homepage URL
Email yukondo@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)

IRB Contact (For public release)
Organization Gunma University
Address Showa-machi, maebashi Gunma
Tel 027-220-7111
Email yukondo@gunma-u.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

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 01 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
2018 Year 10 Month 01 Day
Date of IRB
2018 Year 09 Month 05 Day
Anticipated trial start date
2018 Year 10 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 06 Month 25 Day
Last modified on
2019 Year 06 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037783

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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