UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037791 |
|---|---|
| Receipt number | R000043093 |
| Scientific Title | The usefulness of Healing Touch by nurses for home care patient |
| Date of disclosure of the study information | 2019/08/24 |
| Last modified on | 2020/09/03 11:12:06 |
* 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
The usefulness of Healing Touch by nurses for home care patient
Acronym
The usefulness of Healing Touch by nurses for home care patient
Scientific Title
The usefulness of Healing Touch by nurses for home care patient
Scientific Title:Acronym
The usefulness of Healing Touch by nurses for home care patient
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of usual care adding to Healing Touch for home care patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical and Mental symptom(Visual Analogue Scale)
Key secondary outcomes
Change of Mood(Profile of Mood States2)
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
Ususal Care+Healing Touch, one weekly 4 weeks
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
1)Home treatment patient who receives home nursing care
2)Level and awareness:Clear
3)Body movements:Moderate
4)Patient who can communicate with verbal or non-verbal as pen talk
Key exclusion criteria
1)severe mental and physical symptoms and pain.
2)Level and awareness:not clear
3)Unstable vital signs
4)Not keeping same position for 20 minutes, or in a strong movement
5)difficulty to understand what we say, or to recognize. No or poor response for our question.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kumiko |
| Middle name | |
| Last name | Morita |
Organization
Tokyo Medical and Dental University
Division name
Graduate school of Health Care Scientce, Department of Community Health Promotion Nursing
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5337
morita.phn@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Harumi |
| Middle name | |
| Last name | Yamamoto |
Organization
Tokyo Medical and Dental University
Division name
Graduate school of Health Care Scientce, Department of Community Health Promotion Nursing
Zip code
113-8619
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5337
Homepage URL
yamahs@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental 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
Tokyo Medical and Dental University
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-5096
morita.phn@tmd.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
| 2019 | Year | 08 | Month | 24 | 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
9
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
| 2019 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 09 | Month | 15 | Day |
Date trial data considered complete
| 2020 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 10 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 24 | Day |
Last modified on
| 2020 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043093
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
