UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018411 |
|---|---|
| Receipt number | R000021235 |
| Scientific Title | Pilot study of the hand treatment which reduces a palliative care unit inpatient's feeling of worthlessness |
| Date of disclosure of the study information | 2015/12/01 |
| Last modified on | 2022/01/31 16:01:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Pilot study of the hand treatment which reduces a palliative care unit inpatient's feeling of worthlessness
Acronym
the hand treatment which reduces a palliative care unit inpatient's feeling of worthlessness
Scientific Title
Pilot study of the hand treatment which reduces a palliative care unit inpatient's feeling of worthlessness
Scientific Title:Acronym
the hand treatment which reduces a palliative care unit inpatient's feeling of worthlessness
Region
| Japan |
Condition
Condition
Cancer patient
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We verify the effect of the hand treatment which reduces the feeling of worthlessness of the patient who is in a palliative care unit.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cancer Fatigue Scale
evaluation time: Just before intervention and immediately after intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Hand treatment
Enforcement period: Three to six after patch test enforcement days
Enforcement time: 10 minutes
Number of times: 3 times
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
cancer patient in the hospital
Key exclusion criteria
a patient with generation of heat beyond patient
aggravation of somatic symptoms is predicted to be with a patient
hand treatment with consciousness disorder, dementia, and symptomatic brain transition
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | yoko |
| Middle name | |
| Last name | iwawaki |
Organization
Kyoto Prefectural university of Medicine
Division name
School of Medicine, Department of Nursing
Zip code
602-0857
Address
410, Nakagoryo-cho, Kamigyo-ku, Kyoto-shi, Kyoto
TEL
075-212-5446
iwawaki@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | YOKO |
| Middle name | |
| Last name | iwawaki |
Organization
Kyoto Prefectural university of Medicine
Division name
School of Medicine, Department of Nursing
Zip code
6020857
Address
School of Medicine, Department of Nursing
TEL
075-212-5446
Homepage URL
iwawaki@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine School of Nursing
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural university of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural university of Medicine
Address
410, Nakagoryo-cho, Kamigyo-ku, Kyoto-shi, Kyoto
Tel
0752125446
iwawaki@koto.kpu-m.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
| 2015 | Year | 12 | 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
Completed
Date of protocol fixation
| 2015 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 05 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 24 | Day |
Last modified on
| 2022 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021235
