UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033131 |
|---|---|
| Receipt number | 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 | 2023/06/29 09:24:26 |
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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
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
yukondo@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
Gunma University
Address
Showa-machi, maebashi Gunma
Tel
027-220-7111
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
https://www.jstage.jst.go.jp/article/jjsnr/42/3/42_20190731394/_article/-char/ja/
Publication of results
Partially published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jjsnr/42/3/42_20190731394/_article/-char/ja/
Number of participants that the trial has enrolled
5
Results
The VAS value of pain was significantly different before and after the hand bath day (p = 0.043). There was no significant difference between the groups on the hand bath day and the control day (p = 0.460). As a result of the content analysis of the interview, 113 recording units, 58 codes, 26 subcategories, 11 categories [warming], [relaxing], [pain relief], etc. were extracted.
Results date posted
| 2021 | Year | 06 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The average age was 45.6years for 3 males and 2 females.
Participant flow
They were divided into group A (hand bath day-control day) and group B (control day-hand bath day) in the order in which consent was obtained.
Adverse events
none
Outcome measures
Visual analogue scale
Intervieiw
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2023 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037783
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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